ClinicalTrials.gov
History of Changes for Study: NCT02399085
Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL (L-MIND)
Latest version (submitted September 28, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 25, 2015 None (earliest Version on record)
2 August 31, 2015 Study Status, Eligibility, Arms and Interventions and Oversight
3 December 23, 2015 Recruitment Status, Study Status and Contacts/Locations
4 February 5, 2016 Contacts/Locations and Study Status
5 March 9, 2016 Contacts/Locations and Study Status
6 October 21, 2016 Contacts/Locations, Study Status, Eligibility, Outcome Measures and Study Description
7 December 15, 2016 Study Status and Study Identification
8 August 9, 2017 Study Status and Contacts/Locations
9 December 5, 2017 Recruitment Status, Study Status, Contacts/Locations, Outcome Measures, Arms and Interventions, Study Design and Conditions
10 June 4, 2019 Study Status
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Results Submission Events
11 January 23, 2020 Outcome Measures, Study Status, Document Section, Results, Arms and Interventions and Study Design
12 February 5, 2020 Study Status
13 September 1, 2021 References, Contacts/Locations, Study Status and Oversight
14 February 9, 2023 Recruitment Status, Contacts/Locations, Study Status and Participant Flow
15 February 9, 2023 Participant Flow, Contacts/Locations and Study Status
16 March 13, 2023 Study Status
17 September 28, 2023 Outcome Measures, Adverse Events, Document Section, Participant Flow, References, Arms and Interventions, Study Status, More Information, Study Description, Study Identification, Baseline Characteristics, IPDSharing, Contacts/Locations, Eligibility and Conditions
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Study NCT02399085
Submitted Date:  September 28, 2023 (v17)
Open or close this module Study Identification
Unique Protocol ID: MOR208C203
Brief Title: Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL (L-MIND)
Official Title: A Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined With MOR00208 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL)
Secondary IDs: 2014-004688-19 [EudraCT Number]
Open or close this module Study Status
Record Verification: September 2023
Overall Status: Completed
Study Start: March 29, 2016
Primary Completion: November 14, 2022 [Actual]
Study Completion: April 19, 2023 [Actual]
First Submitted: March 13, 2015
First Submitted that
Met QC Criteria:		 March 25, 2015
First Posted: March 26, 2015 [Estimate]
Results First Submitted: November 27, 2019
Results First Submitted that
Met QC Criteria:		 January 23, 2020
Results First Posted: February 5, 2020 [Actual]
Last Update Submitted that
Met QC Criteria:		 September 28, 2023
Last Update Posted: October 23, 2023 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: MorphoSys AG
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This is a Phase II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of Lenalidomide Combined with MOR00208 in Participants with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R-R DLBCL).
Detailed Description:

The aim of this single-arm, multicentre, open-label Phase II study is to evaluate the Lenalidomide (LEN) combined with Tafasitamab (MOR00208) in adult participants with DLBCL who had relapsed after or were refractory to at least one, but no more than three previous systemic regimens administered for the treatment of their DLBCL and who were not candidates for high-dose chemotherapy and subsequent Autologous stem cell transplants and were thus considered to have exhausted their therapeutic options. One prior therapy line had to include an anti-CD20 targeted therapy (e.g., rituximab [RTX]).

MOR00208 and LEN were administered for up to 12 cycles (28 days each), followed by MOR00208 monotherapy until progression, in participants with at least stable disease or a better response.
Open or close this module Conditions
Conditions: Diffuse Large B-cell Lymphoma
Keywords: DLBCL
Efficacy
MOR00208
Tafasitamab
lenalidomide
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 81 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Tafasitamab (MOR00208) + lenalidomide (LEN)

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

 Drug: Tafasitamab
12 mg/kg
Other Names:
  • MOR00208
Drug: Lenalidomide
25 mg
Other Names:
  • LEN
  • Revlimid®
Open or close this module Outcome Measures
[See Results Section.]
Primary Outcome Measures:
1. Number of Participants With Best Objective Response Rate (ORR)
[ Time Frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled ]

ORR = complete response [CR] + partial response [PR]; Independent Radiology/Clinical Review Committee (IRC) Evaluation.

ORR after MOR00208 and Lenalidomide combination therapy assessed by the IRC evaluation.

ORR was defined as the number of participants of the total number of participants treated with MOR00208 + LEN with CR or PR as best response achieved at any time during the study.
Secondary Outcome Measures:
1. Duration of Response (DoR) by IRC Evaluation
[ Time Frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled ]

DoR [months] = (date of assessment of tumor progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.
2. DoR by Investigator (INV) Evaluation
[ Time Frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled ]

DoR [months] = (date of assessment of tumour progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.
3. Progression-free Survival (PFS) by IRC Evaluation
[ Time Frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled ]

PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.
4. PFS by INV Evaluation
[ Time Frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled ]

PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.
5. Overall Survival (OS)
[ Time Frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled ]

OS was defined as the time from the date of the first administration of any study drug until death from any cause (documented by the date of death).
6. Disease Control Rate (DCR) by IRC Evaluation
[ Time Frame: Approximately 2.5 years after first participant enrolled ]

DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.
7. DCR by INV Evaluation
[ Time Frame: Approximately 2.5 years after first participant enrolled ]

DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.
8. Time to Progression (TTP) by IRC Evaluation
[ Time Frame: Approximately 2.5 years after first participant enrolled ]

TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.
9. TTP by INV Evaluation
[ Time Frame: Approximately 2.5 years after first participant enrolled ]

TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.
10. Time to Next Treatment (TTNT)
[ Time Frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled ]

Kaplan-Meier analysis of TTNT in FAS population. TTNT is defined as the time from the first administration of any study drug to the institution of next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity and participant preference) or death of any cause, whatever comes first.
11. Event-free Survival (EFS) by IRC Evaluation
[ Time Frame: Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled ]

EFS is defined as the time (in months) from the date of the first administration of any study drug to the date of tumour progression, first initiation of a new non-study anti-neoplastic therapy or death from any cause whichever comes first.
12. Serum Drug Levels of MOR00208
[ Time Frame: Cycle 1 Days 1, 4, 15 predose and 1 hr post-dose; Cycle 2 Days 1, 15 predose and 1 hr post-dose; Cycle 3 Days 1, 15 predose and 1 hr post-dose; Cycles 4, 5, 6, 7, 9, 11,13, 15, 17, 19, 21, 23 Day 1 predose; End of Treatment ]

The pharmacokinetics (PK) profile of MOR00208 was investigated by quantifying serum drug levels at baseline and after repeated IV administrations for up to 24 treatment cycles using sparse sampling.

MOR00208 PK sample was taken pre-dose and 1 hour ± 10 min after the end of MOR00208 infusion for Cycle 1 to Cycle 23. MOR00208 PK sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21, 23).
13. Number of Participants Who Developed Anti-MOR00208 Antibodies
[ Time Frame: Baseline, Up to a maximum of 23 cycles. ]

The Anti-MOR00208 Antibodies were investigated by quantifying serum drug levels at baseline and after repeated intravenous (IV) administrations planned for up to 24 treatment cycles using sparse sampling. Anti-MOR00208 antibody sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21,23).
14. Number of Participants That Experienced Treatment-emergent Adverse Events (TEAEs)
[ Time Frame: Approximately 6.5 years after first participant enrolled ]

TEAEs are defined as any adverse event reported in the following time interval (including the lower and upper limits): date of first administration of study treatment; date of last administration of study treatment + 30 days, or if they are considered to be related to the study drug.
15. Severity of Treatment-emergent Adverse Events (TEAEs)
[ Time Frame: Approximately 6.5 years after first participant enrolled ]

Number of participants with Severity of TEAEs during MOR00208 and LEN combination therapy.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Major Inclusion Criteria:

  1. Age >18 years
  2. Histologically confirmed diagnosis of DLBCL
  3. Tumour tissue for central pathology review and correlative studies had to be provided.
  4. Participants must had:
    • relapsed and/or refractory disease
    • at least one bidimensionally measurable, PET positive disease site (transverse diameter of ≥1.5 cm and perpendicular diameter of ≥1.0 cm at baseline)
    • received at least one, but no more than three previous systemic regimens for the treatment of DLBCL and one therapy line must had included a CD20-targeted therapy
    • Eastern Cooperative Oncology Group 0 to 2
  5. Participants were not considered in the opinion of the investigator eligible, or participants unwilling to undergo intensive salvage therapy including ASCT
  6. Participants had to meet the following laboratory criteria at screening:
    • absolute neutrophil count ≥1.5 × 10˄9/L
    • platelet count ≥90 × 10˄9/L
    • total serum bilirubin ≤2.5 × ULN or ≤5 × ULN in cases of Glibert's Syndrome or liver involvement by lymphoma
    • alanine transaminase, aspartate aminotransferase and alkaline phosphatase ≤3 × ULN or <5 × ULN in cases of liver involvement
    • serum creatinine clearance ≥60 mL/minute
  7. Females of childbearing potential (FCBP) must:
    • not be pregnant
    • refrain from breastfeeding and donating blood or oocytes
    • agreed to ongoing pregnancy testing
    • committed to continued abstinence from heterosexual intercourse, or agree to use and be able to comply with the use of double-barrier contraception
  8. Males (if sexually active with a FCBP) had to
    • use an effective barrier method of contraception
    • refrain from donating blood or sperm
  9. In the opinion of the investigator the participants had to:
    • be able and willing to receive adequate prophylaxis and/or therapy for thromboembolic events
    • be able to understand, give written informed consent and comply with all study-related procedures, medication use, and evaluations
    • had no history of noncompliance in relation to medical regimens or not be considered potentially unreliable and/or uncooperative
    • be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and gave written acknowledgement of this.

Major Exclusion Criteria:

  1. Participants who had:
    • other histological type of lymphoma
    • primary refractory DLBCL
    • a history of "double/triple hit" genetics
  2. Participants who had, within 14 days prior to Day 1 dosing:
    • not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
    • underwent major surgery or suffered from significant traumatic injury
    • received live vaccines.
    • required parenteral antimicrobial therapy for active, intercurrent infections
  3. Participants who:
    • had, in the opinion of the investigator, not recovered sufficiently from the adverse toxic effects of prior therapies
    • were previously treated with CD19-targeted therapy or immunomodulatory drugs (IMiDs)® (e.g., thalidomide, LEN)
    • had a history of hypersensitivity to compounds of similar biological or chemical composition to MOR00208, IMiDs® and/or the excipients contained in the study drug formulations
    • had undergone ASCT within the period ≤ 3 months prior to the signing of the Informed Consent Form. Patients who had a more distant history of ASCT had to exhibit full haematological recovery before enrolment into the study
    • had undergone previous allogenic stem cell transplantation
    • had a history of deep venous thrombosis/embolism, threatening thromboembolism or known thrombophilia or were at a high risk for a thromboembolic event in the opinion of the investigator and who were not willing/able to take venous thromboembolic event prophylaxis during the entire treatment period
    • concurrently used other anti-cancer or experimental treatments
  4. Prior history of malignancies other than DLBCL, unless the participant had been free of the disease for ≥5 years prior to screening.
  5. Participants with:
    • positive hepatitis B and/or C serology.
    • known seropositivity for or history of active viral infection with human immunodeficiency virus (HIV)
    • CNS lymphoma involvement
    • history or evidence of clinically significant cardiovascular, CNS and/or other systemic disease that would in the investigator's opinion preclude participation in the study or compromised the participant's ability to give informed consent.
Open or close this module Contacts/Locations
Study Officials: Johannes Duell, MD
Principal Investigator
MorphoSys AG
Locations: United States, California
CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center
Bakersfield, California, United States, 93309
UCLA - David Geffen School of Medicine
Los Angeles, California, United States, 90095
Cancer Care - Torrance Memorial Physician Network
Redondo Beach, California, United States, 90277
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
United States, Colorado
St. Mary's Hospital And Regional Medical Center
Grand Junction, Colorado, United States, 81501
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Michigan
St. Joseph Mercy Hospital Cancer Care Center
Ypsilanti, Michigan, United States, 48179
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, South Carolina
Charleston Hematology Oncology Associates
Charleston, South Carolina, United States, 29414
United States, Texas
Tyler Hematology-Oncology
Tyler, Texas, United States, 75701
Belgium
ZNA Middelheim dep Klinische studies Hematologie
Antwerp, Belgium, 2020
AZ Groeninge-Campus Maria's Voorzienigheid
Kortrijk, Belgium, 8500
Centre Hospitalier Universitaire (CHU) de Liege
Liege, Belgium, 4000
Clinique Universitaire de Mont Godinne
Yvoir, Belgium, 5530
Czechia
University Hospital Olomouc Hematoonkologicka klinika
Olomouc, Czechia, 779 00
France
CHU De Clermont Ferrand - Hopital Estaing Service Hematologie Clinique Et Thrapie Cellulaire
Clermont-Ferrand, France, 63000
Centre Hospitalier Universitaire (CHU) De Limoges Hopital Dupuytren
Limoges, France, 87042
Centre Hospitalier Lyon-Sud (CHLS)
Lyon, France, 69495
Hopital Universitaire Necker Enfants Malades Service de Hematologie Adultes
Paris, France, 75015
Germany
Universitatsklinikum Essen, Abteilung Haematologie
Essen, Germany, 45147
Krankenhaus Nordwest GmbH - Institut Fuer Klinisch-Onkologische Forschung (IKF)
Frankfurt, Germany, 60488
Klinikum Grosshadern-Klinikum Der Ludwig-Maximilian Universitaet Muenchen
Munich, Germany, 81337
Klinikum Nuernberg Nord Medizinische Klinik 5 Hamatologie
Nürnberg, Germany, 90419
Universitaetsklinikum Wuerzburg
Würzburg, Germany, 97080
Hungary
Semmelweis Egyetem I. Sz. Belgyogyaszati Klinika-Semmelweis University
Budapest, Hungary, 1038
National Institute of Oncology Hematological Department
Budapest, Hungary, 1122
DEKK, Belgyogyaszati Klinika
Debrecen, Hungary, 4032
Somogy Megyei Kaposi Mor Oktato Korhaz (Kaposi Mor County Hospital)
Kaposvár, Hungary, 7400
Italy
Azienda Ospedaliera Univerisitaria Policlinico Consorziale Di Bari UOC Ematologia con Trapianto
Bari, Italy, 70124
Ist.Ematologia E Oncologia Medica L.E A.Seragnoli Azienda Ospedaliero-Universitaria, Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Azienda Ospedaliero Universitaria Careggi-S.O.D. Patologia Medica
Firenze, Italy, 50134
Azienda Ospedaliero - Universitaria Policlinico di Modena Dip di Medicina Diagnostica, Clinica e di Sanità Pubblica
Modena, Italy, 41124
AOU Maggiore della Cartia
Novara, Italy, 28100
A .O. S. Maria della Misericordia
Perugia, Italy, 6132
Tor Vergata University Department Of Hematology
Roma, Italy, 00133
Az Ospedaliera Santa Maria Facolta di Medicina e Chirurgia
Terni, Italy, 5100
A.O.U. Citta della Salute e della Scienza di Torino
Torino, Italy, 10126
Poland
Pratia MCM Krakow
Krakow, Poland, 30-510
Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSWiA z Warmimsko
Olsztyn, Poland, 10228
Szpital Wojewodzk I w Opolu SP ZOZ Oddzial Hematologii i Onkologii Hematologicznej
Opole, Poland, 45061
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych w Poznaniu im. prof. Ludwika Bierkowskiego
Poznan, Poland, 60631
Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie
Rzeszow, Poland, 35055
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, Poland, 02781
MTZ Clinical Research Sp. z o.o
Warszawa, Poland, 02106
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy Klinika Nowotworow Ukladu Chlonnego Ul.
Warszawa, Poland, 02781
Spain
Hospital Universitari Germans Trias i Pujol (HUGTP)
Badalona, Spain, 08916
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Institut Catala D'Oncologia-Hospital Duran Y Reynals
Barcelona, Spain, 08097
Hospital Universitario Fundacion Jimenez Diaz Servicio de Hematologia Unidad de Linformas Oncohealth Institute
Madrid, Spain, 28040
Hospital Universitario Puerta de Hierro de Majadahonda
Madrid, Spain, 28222
Complejo Hospitalario de Navarra (CHN)
Pamplona, Spain, 31008
Hospital Universitario Quiron Salud Madrid
Pozuelo De Alarcón, Spain, 28223
Hospital Universitario Virgen del Rocio, Hospital de la Mujer Servicio de Hematologia
Sevilla, Spain, 41013
United Kingdom
The Royal Bournemouth & Christchurch Hospitals
Bournemouth, United Kingdom, BH77DW
Royal Liverpool University Hospital - Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom, L7 8XP
Sarah Cannon Research Institute
London, United Kingdom, W1G 6AD
The Newcastle Hospitals NHS Foundation Trust
Newcastle, United Kingdom, NE7 7DN
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations: [Study Results] Salles G, Duell J, Gonzalez Barca E, Tournilhac O, Jurczak W, Liberati AM, Nagy Z, Obr A, Gaidano G, Andre M, Kalakonda N, Dreyling M, Weirather J, Dirnberger-Hertweck M, Ambarkhane S, Fingerle-Rowson G, Maddocks K. Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study. Lancet Oncol. 2020 Jul;21(7):978-988. doi: 10.1016/S1470-2045(20)30225-4. Epub 2020 Jun 5. PubMed 32511983
[Study Results] Duell J, Maddocks KJ, Gonzalez-Barca E, Jurczak W, Liberati AM, De Vos S, Nagy Z, Obr A, Gaidano G, Abrisqueta P, Kalakonda N, Andre M, Dreyling M, Menne T, Tournilhac O, Augustin M, Rosenwald A, Dirnberger-Hertweck M, Weirather J, Ambarkhane S, Salles G. Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma. Haematologica. 2021 Sep 1;106(9):2417-2426. doi: 10.3324/haematol.2020.275958. PubMed 34196165
[Study Results] Duell J, Obr A, Augustin M, Endell J, Liu H, Geiger S, Silverman IM, Ambarkhane S, Rosenwald A. CD19 expression is maintained in DLBCL patients after treatment with tafasitamab plus lenalidomide in the L-MIND study. Leuk Lymphoma. 2022 Feb;63(2):468-472. doi: 10.1080/10428194.2021.1986219. Epub 2021 Nov 15. No abstract available. PubMed 34779360
Links: Description: CD19 expression is maintained in DLBCL patients after treatment with tafasitamab plus lenalidomide in the L-MIND study
Description: Tafasitamab plus lenalidomide in relapsed or refractory diffuse large B-cell lymphoma (L-MIND): a multicentre, prospective, single-arm, phase 2 study
Description: Long-term outcomes from the Phase II L-MIND study of tafasitamab (MOR208) plus lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma
Available IPD/Information:
Open or close this module Document Section
Study Protocol
Document Date: February 24, 2021
Uploaded: 07/21/2023 07:59
File Name: Prot_001.pdf
Statistical Analysis Plan
Document Date: February 10, 2023
Uploaded: 07/21/2023 08:01
File Name: SAP_002.pdf
Study Results
Open or close this module Participant Flow
Recruitment Details The participants were enrolled into this study at sites in Hungary, Belgium, Czechia, France, Poland, Italy, Germany, Spain, United Kingdom, and the United States.
Pre-assignment Details
 
Arm/Group Title Treatment (MOR00208, Lenalidomide)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.
Period Title: Overall Study
Started 81
Received MOR00208 + LEN 80
Received MOR00208 Only 1
Completed: Participants Who Were Still on Treatment at EOS 8
Not Completed: Participants Who Were no Longer Receiving Treatment at EOS 73
Completed 8
Not Completed 73
Reason Not Completed
Adverse Event 16
Death 2
Withdrawal by Subject 8
Progressive disease/ Disease relapse 42
Physician Decision 5
Open or close this module Baseline Characteristics
Arm/Group TitleTreatment (MOR00208, Lenalidomide)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Baseline Participants 81
Baseline Analysis Population Description [Not Specified]
Age, Categorical
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed81 Participants
<=18 years
0
0%
Between 18 and 65 years
23
28.4%
>=65 years
58
71.6%
Age, Continuous
Mean (Standard Deviation)
Unit of measure: years
Number Analyzed81 Participants
69.3(9.53)
Sex: Female, Male
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed81 Participants
Female
37
45.68%
Male
44
54.32%
Race (NIH/OMB)
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed81 Participants
American Indian or Alaska Native
0
0%
Asian
2
2.47%
Native Hawaiian or Other Pacific Islander
0
0%
Black or African American
0
0%
White
72
88.89%
More than one race
0
0%
Unknown or Not Reported
7
8.64%
Region of Enrollment
Measure Type: Count of Participants
Unit of measure: Participants
Number Analyzed81 Participants
Hungary
7
8.64%
Belgium
5
6.17%
United States
6
7.41%
Czechia
3
3.7%
Poland
7
8.64%
Italy
13
16.05%
United Kingdom
5
6.17%
France
9
11.11%
Germany
11
13.58%
Spain
15
18.52%
Open or close this module Outcome Measures
1. Primary Outcome:
Title Number of Participants With Best Objective Response Rate (ORR)
Description

ORR = complete response [CR] + partial response [PR]; Independent Radiology/Clinical Review Committee (IRC) Evaluation.

ORR after MOR00208 and Lenalidomide combination therapy assessed by the IRC evaluation.

ORR was defined as the number of participants of the total number of participants treated with MOR00208 + LEN with CR or PR as best response achieved at any time during the study.

Time Frame Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description
Full analysis set (FAS): The FAS included all participant who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once.
 
Arm/Group TitleTreatment (MOR00208, Lenalidomide)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

Overall Number of Participants Analyzed80
Measure Type: Count of Participants
Unit of Measure: Participants
Approximately 4.5 years after first participant enrolled
46
57.5%
Approximately 6.5 years after first participant enrolled
46
57.5%
2. Secondary Outcome:
Title Duration of Response (DoR) by IRC Evaluation
Description DoR [months] = (date of assessment of tumor progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.
Time Frame Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description
FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
 
Arm/Group TitleTreatment (MOR00208, Lenalidomide)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

Overall Number of Participants Analyzed46
Median (95% Confidence Interval)
Unit of Measure: Months
Approximately 4.5 years after first participant enrolled
43.9(26.1 to NA) [1]
Approximately 6.5 years after first participant enrolled
NA(33.8 to NA) [2]
[1]NA Explanation: [Not available]. Upper limit not reached due to insufficient number of events at later stages of follow-up.
[2]NA Explanation: [Not available]. Median and upper limit not reached due to insufficient number of events at later stages of follow-up.
3. Secondary Outcome:
Title DoR by Investigator (INV) Evaluation
Description DoR [months] = (date of assessment of tumour progression or death - date of assessment of first documented response of (CR or PR) + 1)/30.4375.
Time Frame Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description
FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
 
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

Overall Number of Participants Analyzed52
Median (95% Confidence Interval)
Unit of Measure: Months
Approximately 4.5 years after first participant enrolled
43.9(13.9 to NA) [1]
Approximately 6.5 years after first participant enrolled
43.4(14.1 to NA) [1]
[1]NA Explanation: Not available. Upper limit not reached due to insufficient number of events at later stages of follow-up.
4. Secondary Outcome:
Title Progression-free Survival (PFS) by IRC Evaluation
Description PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.
Time Frame Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description
FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
 
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Participants Analyzed42
Median (95% Confidence Interval)
Unit of Measure: Months
Approximately 4.5 years after first participant enrolled
11.6(6.3 to 45.7)
Approximately 6.5 years after first participant enrolled
11.6(5.7 to 45.7)
5. Secondary Outcome:
Title PFS by INV Evaluation
Description PFS time was defined as the time (in months) from the date of the first administration of any study drug to the date of tumor progression or death from any cause.
Time Frame Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description
FAS: The FAS includes all participants who received at least one dose of MOR00208 and one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
   
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Participants Analyzed49
Median (95% Confidence Interval)
Unit of Measure: Months
 
Approximately 4.5 years after first participant enrolled
Number Analyzed Participants
9.1(5.5 to 28.0)
Approximately 6.5 years after first participant enrolled
Number Analyzed Participants
9.1(5.5 to 45.5)
6. Secondary Outcome:
Title Overall Survival (OS)
Description OS was defined as the time from the date of the first administration of any study drug until death from any cause (documented by the date of death).
Time Frame Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description
FAS: The FAS includes all participants who received at least one dose of MOR00208 and one dose of LEN. This means that both study drugs must have been applied at least once. Inclusive of participants with available data.
   
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Participants Analyzed44
Median (95% Confidence Interval)
Unit of Measure: Months
 
Approximately 4.5 years after first participant enrolled
Number Analyzed Participants
33.5(18.3 to NA) [1]
Approximately 6.5 years after first participant enrolled
Number Analyzed Participants
33.5(18.3 to NA) [1]
[1]NA Explanation: Not available. Upper limit not reached due to insufficient number of events at later stages of follow-up.
7. Secondary Outcome:
Title Disease Control Rate (DCR) by IRC Evaluation
Description DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.
Time Frame Approximately 2.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description
FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once.
 
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Participants Analyzed80
Measure Type: Count of Participants
Unit of Measure: Participants
59
73.8%
8. Secondary Outcome:
Title DCR by INV Evaluation
Description DCR = CR + PR + SD (Stable disease); IRC Evaluation DCR was defined as the number of participants having CR, PR or SD based on the best objective response achieved at any time during the study.
Time Frame Approximately 2.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description
FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once.
 
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Participants Analyzed80
Measure Type: Count of Participants
Unit of Measure: Participants
60
75%
9. Secondary Outcome:
Title Time to Progression (TTP) by IRC Evaluation
Description TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.
Time Frame Approximately 2.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description
FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
 
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Participants Analyzed35
Median (95% Confidence Interval)
Unit of Measure: Months
16.2(7.4 to NA) [1]
[1]NA Explanation: Not available. Upper limit not reached due to insufficient number of events at later stages of follow-up.
10. Secondary Outcome:
Title TTP by INV Evaluation
Description TTP is defined as the time from the first administration of any study drug until documented DLBCL progression or death as a result of lymphoma.
Time Frame Approximately 2.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description
FAS: The FAS included all participants who received at least one dose of MOR00208 and at least one dose of LEN. This meant that both study drugs had to be administered at least once. Inclusive of participants with available data.
 
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Participants Analyzed40
Median (95% Confidence Interval)
Unit of Measure: Months
14.1(6.3 to NA) [1]
[1]NA Explanation: Not available. Upper limit not reached due to insufficient number of events at later stages of follow-up.
11. Secondary Outcome:
Title Time to Next Treatment (TTNT)
Description Kaplan-Meier analysis of TTNT in FAS population. TTNT is defined as the time from the first administration of any study drug to the institution of next anti-neoplastic therapy (for any reason including disease progression, treatment toxicity and participant preference) or death of any cause, whatever comes first.
Time Frame Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description
FAS: The FAS includes all participants who received at least one dose of MOR00208 and one dose of LEN. This means that both study drugs must have been applied at least once. Inclusive of participants with available data.
   
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Participants Analyzed55
Median (95% Confidence Interval)
Unit of Measure: Months
 
Approximately 4.5 years after first participant enrolled
Number Analyzed Participants
12.1(7.3 to 24.7)
Approximately 6.5 years after first participant enrolled
Number Analyzed Participants
12.5(7.3 to 28)
12. Secondary Outcome:
Title Event-free Survival (EFS) by IRC Evaluation
Description EFS is defined as the time (in months) from the date of the first administration of any study drug to the date of tumour progression, first initiation of a new non-study anti-neoplastic therapy or death from any cause whichever comes first.
Time Frame Approximately 4.5 years after first participant enrolled; Approximately 6.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description
FAS: The FAS includes all participants who received at least one dose of MOR00208 and one dose of LEN. This means that both study drugs must have been applied at least once. Inclusive of participants with available data.
   
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Participants Analyzed55
Median (95% Confidence Interval)
Unit of Measure: Months
 
Approximately 4.5 years after first participant enrolled
Number Analyzed Participants
8.7(5.3 to 21.0)
Approximately 6.5 years after first participant enrolled
Number Analyzed Participants
9.1(5.3 to 23.5)
13. Secondary Outcome:
Title Serum Drug Levels of MOR00208
Description

The pharmacokinetics (PK) profile of MOR00208 was investigated by quantifying serum drug levels at baseline and after repeated IV administrations for up to 24 treatment cycles using sparse sampling.

MOR00208 PK sample was taken pre-dose and 1 hour ± 10 min after the end of MOR00208 infusion for Cycle 1 to Cycle 23. MOR00208 PK sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21, 23).

Time Frame Cycle 1 Days 1, 4, 15 predose and 1 hr post-dose; Cycle 2 Days 1, 15 predose and 1 hr post-dose; Cycle 3 Days 1, 15 predose and 1 hr post-dose; Cycles 4, 5, 6, 7, 9, 11,13, 15, 17, 19, 21, 23 Day 1 predose; End of Treatment
Outcome Measure Data
Analysis Population Description

PK analysis set (PKAS): The PKAS included all participants who received at least one dose of MOR00208 and had at least one quantifiable MOR00208 serum concentration.

Number analyzed includes only participants with data at each timepoint.

   
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Participants Analyzed81
Mean (Standard Deviation)
Unit of Measure: ng/mL
 
Cycle 1 Day 1 (Predose)
Number Analyzed Participants
6.7(53.09)
Cycle 1 Day 1 (1 hour post dose)
Number Analyzed Participants
249075.9(53724.93)
Cycle 1 Day 4 (pre-dose)
Number Analyzed Participants
126306.8(39105.37)
Cycle 1 Day 4 (1 hour post-dose)
Number Analyzed Participants
363626.2(82971.54)
Cycle 1 Day 15 (pre dose)
Number Analyzed Participants
157722.3(50655.86)
Cycle 1 Day 15 (1 hour post-dose)
Number Analyzed Participants
396262.1(97215.09)
Cycle 2 Day 1 (predose)
Number Analyzed Participants
181870.8(72582.62)
Cycle 2 Day 1 (1 hour post-dose)
Number Analyzed Participants
439788.2(126930.55)
Cycle 2 Day 15 (Pre Dose)
Number Analyzed Participants
217846.9(77799.93)
Cycle 2 Day 15 (1 hour post-dose) )
Number Analyzed Participants
442940.2(85475.90)
Cycle 3 Day 1 (predose)
Number Analyzed Participants
208520.6(68866.46)
Cycle 3 Day 1 (1 hour post-dose)
Number Analyzed Participants
466135.8(112647.31)
Cycle 3 Day 15 (predose)
Number Analyzed Participants
223909.4(85170.91)
Cycle 3 Day 15 (1 hour post-dose)
Number Analyzed Participants
455635.0(104198.64)
Cycle 4 Day 1 (predose) )
Number Analyzed Participants
216328.4(94553.25)
Cycle 5 Day 1 (pre dose)
Number Analyzed Participants
142134.4(72691.16)
Cycle 6 Day 1 (pre dose)
Number Analyzed Participants
115132.3(55774.77)
Cycle 7 Day 1 (pre dose)
Number Analyzed Participants
114661.5(73328.15)
Cycle 9 Day 1 (pre dose)
Number Analyzed Participants
108640.4(52282.72)
Cycle 11 Day 1 (pre dose)
Number Analyzed Participants
126472.0(64872.47)
Cycle 13 Day 1 (pre dose)
Number Analyzed Participants
100853.5(61229.42)
Cycle 15 Day 1 (pre dose)
Number Analyzed Participants
159676.5(61199.32)
Cycle 17 Day 1 (pre dose)
Number Analyzed Participants
175855.1(64592.17)
Cycle 19 Day 1 (pre dose)
Number Analyzed Participants
197045.0(69962.05)
Cycle 21 Day 1 (pre dose)
Number Analyzed Participants
197228.0(53222.03)
Cycle 23 Day 1 (pre dose)
Number Analyzed Participants
224253.3(64686.85)
End of Treatment
Number Analyzed Participants
141240.7(114804.40)
14. Secondary Outcome:
Title Number of Participants Who Developed Anti-MOR00208 Antibodies
Description The Anti-MOR00208 Antibodies were investigated by quantifying serum drug levels at baseline and after repeated intravenous (IV) administrations planned for up to 24 treatment cycles using sparse sampling. Anti-MOR00208 antibody sample (pre-dose only) were taken in odd numbered additional treatment cycles only (e.g., treatment Cycles 13, 15,17, 19, 21,23).
Time Frame Baseline, Up to a maximum of 23 cycles.
Outcome Measure Data
Analysis Population Description
Immunogenicity analysis set (IAS): The IAS included participants who had at least one anti-MOR00208 antibody assessment.
   
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Participants Analyzed81
Measure Type: Count of Participants
Unit of Measure: Participants
Yes (Treatment-emergent ADAs)
0
0%
No (Negative baseline and post baseline results)
72
88.9%
Not evaluable (Positive baseline results)
2
2.5%
Missing (No post baseline results available)
7
8.6%
15. Secondary Outcome:
Title Number of Participants That Experienced Treatment-emergent Adverse Events (TEAEs)
Description TEAEs are defined as any adverse event reported in the following time interval (including the lower and upper limits): date of first administration of study treatment; date of last administration of study treatment + 30 days, or if they are considered to be related to the study drug.
Time Frame Approximately 6.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description

Safety analysis set (SAF):

The SAF includes all participants who received at least one dose of MOR00208 or LEN and had at least one post-baseline safety assessment.

 
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Participants Analyzed81
Measure Type: Count of Participants
Unit of Measure: Participants
81
100%
16. Secondary Outcome:
Title Severity of Treatment-emergent Adverse Events (TEAEs)
Description Number of participants with Severity of TEAEs during MOR00208 and LEN combination therapy.
Time Frame Approximately 6.5 years after first participant enrolled
Outcome Measure Data
Analysis Population Description

SAF:

The SAF includes all participants who received at least one dose of MOR00208 or LEN and had at least one post-baseline safety assessment.

   
Arm/Group TitleTafasitamab (MOR00208) + Lenalidomide (LEN)
Arm/Group Description

MOR00208:

MOR00208 was administered via IV infusion at a dose of 12 mg/kg. For the first three cycles (Cycles 1 to 3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle.

Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle.

LEN:

Participants self-administered a starting dose of 25 mg oral LEN daily on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings.

On days when both study drugs were given together, LEN was administered prior to MOR00208.

Overall Number of Participants Analyzed81
Measure Type: Count of Participants
Unit of Measure: Participants
Severe
43
53.1%
Moderate
31
38.3%
Mild
6
7.4%
Missing
1
1.2%
Open or close this module Adverse Events
 
Time Frame From first day of study drug administration through 30 days after last dose, up to maximum duration of 6.5 years approximately after first participant enrolled.
Adverse Event Reporting Description All adverse events (AEs) (except non-serious AEs for screening failures) that occurred after the provision of informed consent and up to 30 days after last study drug administration was recorded in the eCRF and in the participant's medical records, whether or not they were considered by the investigator to be related to the study drug. Thereafter, only AEs assessed as related were collected at the end of the study.
 
Arm/Group Title Treatment (MOR00208, Lenalidomide)
Arm/Group Description

MOR00208 was administered via intravenous Infusion, weekly (Cycle 1-3) of the study each cycle consisted of a MOR00208 infusion on Day 1, Day 8, Day 15 and Day 22 of the cycle. Additionally, a loading dose was administered on Day 4 of Cycle 1. Thereafter MOR00208 was administered on a bi-weekly (every 14 days) basis with infusions on Day 1 and Day 15 of each 28-day cycle, until disease progression or unacceptable toxicity or discontinuation due to any other reason.

Lenalidomide (Revlimid®), PO, daily, on Days 1-21 of each cycle, for up to 12 cycles in total. LEN dose could be modified in a de-escalating fashion or discontinued based upon clinical and laboratory findings. Treatment with LEN was stopped in case of disease progression, or unacceptable toxicity, or discontinuation for any other reason.

On days when both study drugs were given together, LEN was administered prior to tafasitamab.
All-Cause Mortality
  Treatment (MOR00208, Lenalidomide)
 Affected / At Risk (%)# Events
Total 45 / 81 (55.56%)
Serious Adverse Events
  Treatment (MOR00208, Lenalidomide)
 Affected / At Risk (%)# Events
Total 47 / 81 (58.02%)
Blood and lymphatic system disorders
Agranulocytosis † A 1 / 81 (1.23%)2
Febrile neutropenia † A 5 / 81 (6.17%)5
Cardiac disorders
Atrial fibrillation † A 2 / 81 (2.47%)2
Cardiac failure congestive † A 2 / 81 (2.47%)2
Cardio-respiratory arrest † A 1 / 81 (1.23%)1
Myocardial ischaemia † A 1 / 81 (1.23%)1
Gastrointestinal disorders
Diarrhoea † A 1 / 81 (1.23%)1
General disorders
Fatigue † A 1 / 81 (1.23%)1
Pyrexia † A 1 / 81 (1.23%)1
Sudden death † A 1 / 81 (1.23%)1
Hepatobiliary disorders
Biliary colic † A 1 / 81 (1.23%)1
Cholecystitis † A 1 / 81 (1.23%)2
Infections and infestations
Bronchitis † A 2 / 81 (2.47%)2
Bronchopulmonary aspergillosis † A 1 / 81 (1.23%)2
COVID-19 † A 3 / 81 (3.7%)3
COVID-19 pneumonia † A 1 / 81 (1.23%)1
Cytomegalovirus infection † A 1 / 81 (1.23%)1
Enterobacter bacteraemia † A 1 / 81 (1.23%)1
Escherichia bacteraemia † A 1 / 81 (1.23%)1
Febrile infection † A 1 / 81 (1.23%)1
Gastroenteritis rotavirus † A 1 / 81 (1.23%)1
Influenza † A 1 / 81 (1.23%)1
Intervertebral discitis † A 1 / 81 (1.23%)1
Klebsiella sepsis † A 1 / 81 (1.23%)1
Lower respiratory tract infection † A 2 / 81 (2.47%)4
Neutropenic sepsis † A 1 / 81 (1.23%)1
Parainfluenzae virus infection † A 1 / 81 (1.23%)1
Pneumonia † A 7 / 81 (8.64%)7
Progressive multifocal leukoencephalopathy † A 1 / 81 (1.23%)1
Respiratory syncytial virus infection † A 1 / 81 (1.23%)1
Respiratory tract infection † A 1 / 81 (1.23%)1
Sepsis † A 1 / 81 (1.23%)2
Soft tissue infection † A 1 / 81 (1.23%)1
Streptococcal sepsis † A 1 / 81 (1.23%)1
Urinary tract infection † A 1 / 81 (1.23%)1
Urinary tract infection enterococcal † A 1 / 81 (1.23%)1
Varicella zoster virus infection † A 1 / 81 (1.23%)1
Injury, poisoning and procedural complications
Femur fracture † A 1 / 81 (1.23%)1
Lower limb fracture † A 1 / 81 (1.23%)1
Wound complication † A 1 / 81 (1.23%)1
Musculoskeletal and connective tissue disorders
Arthritis † A 1 / 81 (1.23%)1
Muscular weakness † A 1 / 81 (1.23%)1
Osteonecrosis † A 1 / 81 (1.23%)1
Pathological fracture † A 1 / 81 (1.23%)1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma † A 2 / 81 (2.47%)2
Bowen's disease † A 1 / 81 (1.23%)1
Breast cancer † A 1 / 81 (1.23%)1
Lung adenocarcinoma † A 1 / 81 (1.23%)1
Myelodysplastic syndrome † A 1 / 81 (1.23%)1
Myeloproliferative neoplasm † A 1 / 81 (1.23%)1
Prostate cancer † A 1 / 81 (1.23%)1
Squamous cell carcinoma † A 2 / 81 (2.47%)2
Tumour flare † A 1 / 81 (1.23%)1
Nervous system disorders
Cerebrovascular accident † A 1 / 81 (1.23%)1
Cervicobrachial syndrome † A 1 / 81 (1.23%)1
Cognitive disorder † A 1 / 81 (1.23%)1
Facial paralysis † A 1 / 81 (1.23%)1
Sciatica † A 1 / 81 (1.23%)1
Transient global amnesia † A 1 / 81 (1.23%)1
Transient ischaemic attack † A 1 / 81 (1.23%)1
Renal and urinary disorders
Renal failure † A 1 / 81 (1.23%)1
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease † A 1 / 81 (1.23%)2
Dyspnoea † A 2 / 81 (2.47%)2
Pulmonary embolism † A 3 / 81 (3.7%)3
Respiratory failure † A 1 / 81 (1.23%)1
Vascular disorders
Deep vein thrombosis † A 1 / 81 (1.23%)1
Haematoma † A 1 / 81 (1.23%)1
†Indicates events were collected by systematic assessment.
ATerm from vocabulary, MedDRA 25.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
  Treatment (MOR00208, Lenalidomide)
 Affected / At Risk (%)# Events
Total 75 / 81 (92.59%)
Blood and lymphatic system disorders
Anaemia † A 30 / 81 (37.04%)74
Febrile neutropenia † A 5 / 81 (6.17%)6
Leukopenia † A 10 / 81 (12.35%)44
Lymphopenia † A 5 / 81 (6.17%)10
Neutropenia † A 40 / 81 (49.38%)215
Thrombocytopenia † A 23 / 81 (28.4%)71
Gastrointestinal disorders
Abdominal pain † A 8 / 81 (9.88%)9
Abdominal pain upper † A 6 / 81 (7.41%)8
Constipation † A 15 / 81 (18.52%)21
Diarrhoea † A 30 / 81 (37.04%)63
Nausea † A 12 / 81 (14.81%)21
Vomiting † A 12 / 81 (14.81%)15
General disorders
Asthenia † A 21 / 81 (25.93%)39
Fatigue † A 13 / 81 (16.05%)24
Mucosal inflammation † A 6 / 81 (7.41%)9
Oedema peripheral † A 20 / 81 (24.69%)35
Pyrexia † A 18 / 81 (22.22%)39
Immune system disorders
Hypogammaglobulinaemia † A 5 / 81 (6.17%)5
Infections and infestations
Bronchitis † A 12 / 81 (14.81%)19
Gastroenteritis † A 6 / 81 (7.41%)9
Nasopharyngitis † A 8 / 81 (9.88%)11
Respiratory tract infection † A 9 / 81 (11.11%)17
Rhinitis † A 7 / 81 (8.64%)7
Sinusitis † A 6 / 81 (7.41%)7
Upper respiratory tract infection † A 8 / 81 (9.88%)9
Urinary tract infection † A 10 / 81 (12.35%)15
Injury, poisoning and procedural complications
Infusion related reaction † A 5 / 81 (6.17%)5
Investigations
Blood alkaline phosphatase increased † A 5 / 81 (6.17%)9
Blood creatinine increased † A 7 / 81 (8.64%)17
C-reactive protein increased † A 9 / 81 (11.11%)12
Gamma-glutamyltransferase increased † A 6 / 81 (7.41%)9
Metabolism and nutrition disorders
Decreased appetite † A 18 / 81 (22.22%)20
Hyperglycaemia † A 5 / 81 (6.17%)18
Hypocalcaemia † A 5 / 81 (6.17%)16
Hypokalaemia † A 15 / 81 (18.52%)28
Hypomagnesaemia † A 8 / 81 (9.88%)26
Musculoskeletal and connective tissue disorders
Arthralgia † A 6 / 81 (7.41%)11
Back pain † A 16 / 81 (19.75%)19
Muscle spasms † A 12 / 81 (14.81%)16
Pain in extremity † A 8 / 81 (9.88%)913
Nervous system disorders
Headache † A 7 / 81 (8.64%)19
Paraesthesia † A 7 / 81 (8.64%)7
Sciatica † A 5 / 81 (6.17%)8
Psychiatric disorders
Anxiety † A 6 / 81 (7.41%)10
Renal and urinary disorders
Dysuria † A 5 / 81 (6.17%)5
Respiratory, thoracic and mediastinal disorders
Cough † A 24 / 81 (29.63%)36
Dyspnoea † A 10 / 81 (12.35%)16
Oropharyngeal pain † A 6 / 81 (7.41%)6
Productive cough † A 5 / 81 (6.17%)5
Skin and subcutaneous tissue disorders
Pruritus † A 8 / 81 (9.88%)9
Rash † A 8 / 81 (9.88%)10
Rash maculo-papular † A 5 / 81 (6.17%)5
Vascular disorders
Hypertension † A 7 / 81 (8.64%)10
Hypotension † A 6 / 81 (7.41%)6
†Indicates events were collected by systematic assessment.
ATerm from vocabulary, MedDRA 25.1
Open or close this module Limitations and Caveats
[Not specified]
Open or close this module More Information
Certain Agreements:
Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact:
Name/Official Title:
 Lisa Walz
Organization:
 MorphoSys AG
Phone:
 +49 89 89927 26240
Email:
 Lisa.Walz@morphosys.com
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