Trial on the Effect of Isatuximab to Lenalidomide/Bortezomib/Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Myeloma (GMMG HD7)

• ClinicalTrials.gov Identifier: NCT03617731
• Recruitment Status: Active, not recruiting
• First Posted: August 6, 2018
• Last Update Posted: May 12, 2023
• Sponsor: University of Heidelberg Medical Center
• Information provided by (Responsible Party): Prof. Dr. Hartmut Goldschmidt, University of Heidelberg Medical Center

Study Description

Brief Summary:

Trial in patients with newly diagnosed myeloma to evaluate the effect of isatuximab in induction therapy with lenalidomide/bortezomib/dexamethasone (RVd) and in lenalidomide maintenance treatment

Condition or disease	Intervention/treatment	Phase
Multiple Myeloma	Drug: Lenalidomide; Drug: Bortezomib; Drug: Dexamethasone; Drug: Isatuximab	Phase 3

Detailed Description:

Prospective, multicentre, randomised, parallel group, open, phase III clinical trial, for patients with confirmed diagnosis of untreated multiple myeloma requiring systemic therapy.

Investigational Medicinal Products: Isatuximab, Lenalidomide

1. Randomization: Patients are randomized in one of 2 study arms (IA or IB) before induction therapy. Patients randomized in arm IA will receive 3 cycles RVd (Bortezomib (Velcade®), Lenalidomide (Revlimid®, each cycle is 42 days), Dexamethasone). Patients in arm IB will additionally receive the monoclonal antibody Isatuximab in the 3 cycles RVd. After induction therapy patients undergo intensifying therapy according to GMMG standard (usually mobilization therapy followed by stem cell collection and autologous stem cell transplantation).
2. Randomization: Before maintenance treatment patients are randomized in one of 2 study arms (IIA and IIB): Patients in arm IIA receive Lenalidomide maintenance therapy for three years, patients in arm IIB receive additional Isatuximab.

There are two primary objectives:

1. to compare the induction regimen (IA vs IB) regarding minimal residual disease (MRD) negativity after induction (assessed by flow cytometry; sensitivity at least 1e-5)
2. to compare the maintenance strategies (arms IIA vs IIB) regarding progression-free survival (PFS), defined as time from 2nd randomization (prior to maintenance therapy) to progression or death from any cause whichever occurs first.

The duration of the trial for each patients is expected to be 45-48 months (induction and intensification treatment: 6-9 months, 3 months rest between intensification and start of maintenance phase 36 months).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 662 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 2 x 2 arms, 1. randomization before induction therapy (arm IA and IB), 2. randomization before maintenance therapy (arm IIA and IIB)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Phase III Trial Assessing the Benefit of the Addition of Isatuximab to Lenalidomide / Bortezomib / Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma
• Actual Study Start Date: October 18, 2018
• Estimated Primary Completion Date: May 2025
• Estimated Study Completion Date: December 2025

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: IA; Patients in arm IA are treated with 3 cycles RVd (lenalidomide 25 mg/d p.o. d1 - 14 and d22 - 35; bortezomib 1.3 mg/m2 s.c. d1, 4, 8, 11, 22, 25, 29, 32; dexamethasone p.o. 20 mg/d d1-2, 4-5, 8-9, 11-12, 15, 22-23, 25-26, 29-30, 32-33).Treatment repeats every 42 days (d43 = cycle 2 d1). Standard intensification: For all patients, stem cells are mobilized by GMMG Standard protocols (CAD: cyclophosphamide, doxorubicin, dexamethasone) and G-CSF. At least 7.5x106 CD34+ cells/kg body weight are harvested. High dose treatment (melphalan 200mg/m², HDT) followed by autologous stem cell transplantation (ASCT) is started 4 - 6 weeks after CAD. For patients not in CR after HDT1, a second HDT is performed within 3 months.	Drug: Lenalidomide; 25 mg per os on day 1-14 and d22-35 in induction cycle 1-3 (Arms IA and IB) 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-39 (Arms IIA and IIB); Other Name: Revlimid; Drug: Bortezomib; all arms: 1,3 mg/m^2 subcutaneous on day 1, 4, 8, 11, 22, 25, 29 32 in 3 induction cycles; Other Name: Velcade; Drug: Dexamethasone; 20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 and 15 and 22,23 and 25,26 and 29,30 and 32,33 in induction cycles 1-3 (Arms IA and IB). Maintenance cycle 1 on day 1, 8, 15, 22 Dexamethasone 20 mg/d per os (Arm IIA). In Arm IIB Dexamethasone 20 mg i.v. on days of Isatuximab infusion in the first maintenance cycle (d 1, 8, 15, 22), dexamethasone will be administered intravenously as part of the premedication. If an isatuximab dose is skipped or discontinued dexamethasone should be administered orally.
Experimental: IB; Patients in arm IB are treated with 3 cycles RVd + Isatuximab (lenalidomide 25 mg/d p.o. d1 - 14 and d22 - 35; bortezomib 1.3 mg/m2 s.c. d1, 4, 8, 11, 22, 25, 29, 32;dexamethasone p.o. 20 mg/d d1-2, 4-5, 8-9, 11-12, 15, 22-23, 25-26, 29-30, 32-33).Isatuximab (10 mg/kg i.v. C1: d 1, 8, 15, 22, 29; C2-3: d 1, 15, 29).Treatment repeats every 42 days (d43 = cycle 2 d1). Standard intensification: For all patients, stem cells are mobilized by GMMG Standard protocols (CAD: cyclophosphamide, doxorubicin, dexamethasone) and G-CSF. At least 7.5x106 CD34+ cells/kg body weight are harvested. High dose treatment (melphalan 200mg/m², HDT) followed by autologous stem cell transplantation (ASCT) is started 4 - 6 weeks after CAD. For patients not in CR after HDT1, a second HDT is performed within 3 months.	Drug: Lenalidomide; 25 mg per os on day 1-14 and d22-35 in induction cycle 1-3 (Arms IA and IB) 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-39 (Arms IIA and IIB); Other Name: Revlimid; Drug: Bortezomib; all arms: 1,3 mg/m^2 subcutaneous on day 1, 4, 8, 11, 22, 25, 29 32 in 3 induction cycles; Other Name: Velcade; Drug: Dexamethasone; 20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 and 15 and 22,23 and 25,26 and 29,30 and 32,33 in induction cycles 1-3 (Arms IA and IB). Maintenance cycle 1 on day 1, 8, 15, 22 Dexamethasone 20 mg/d per os (Arm IIA). In Arm IIB Dexamethasone 20 mg i.v. on days of Isatuximab infusion in the first maintenance cycle (d 1, 8, 15, 22), dexamethasone will be administered intravenously as part of the premedication. If an isatuximab dose is skipped or discontinued dexamethasone should be administered orally.; Drug: Isatuximab; 10 mg/kg in the vein( i.v) on day 1,8,15, 22, 29 in induction cycle 1 on day 1, 15 and 29 in induction cycle 2 and 3 (Arm IB). 10 mg/kg i.v. on day 1,8, 15 and 22 in maintenance cycle 1, 10 mg/kg i.v. on day 1 and 15 in maintenance cycle 2 and 3, 10 mg/kg i.v. on day 1 in maintenance cycle 4 - 39 (Arm IIB)
Active Comparator: IIA; maintenance treatment with Lenalidomide 10mg/d (increased to 15mg/d after 3 months) repeated every 28d. Maintenance treatment is planned for up to 36 months or until progression if progression occurs first.	Drug: Lenalidomide; 25 mg per os on day 1-14 and d22-35 in induction cycle 1-3 (Arms IA and IB) 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-39 (Arms IIA and IIB); Other Name: Revlimid
Experimental: IIB; maintenance treatment with Lenalidomide 10mg/d (increased to 15mg/d after 3 months) + Isatuximab (10 mg/kg; C1: d1, 8, 15, 22; C2-C3: d1 + 15; C4-39:d1, repeated every 28d). Within the trial, maintenance treatment is planned for up to 36 months or until progression if progression occurs first.	Drug: Lenalidomide; 25 mg per os on day 1-14 and d22-35 in induction cycle 1-3 (Arms IA and IB) 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-39 (Arms IIA and IIB); Other Name: Revlimid; Drug: Isatuximab; 10 mg/kg in the vein( i.v) on day 1,8,15, 22, 29 in induction cycle 1 on day 1, 15 and 29 in induction cycle 2 and 3 (Arm IB). 10 mg/kg i.v. on day 1,8, 15 and 22 in maintenance cycle 1, 10 mg/kg i.v. on day 1 and 15 in maintenance cycle 2 and 3, 10 mg/kg i.v. on day 1 in maintenance cycle 4 - 39 (Arm IIB)

Outcome Measures

Primary Outcome Measures :

1. MRD negativity after induction Treatment (comparison of arms IA and IB) [ Time Frame: 18 weeks after start of study treatment ]
   Detection of minimal residual disease by flow cytometry (sensitivity at least 1e-5)
2. Progression Free Survival (PFS) after second randomization (arms IIA and IIB) [ Time Frame: time from 2. randomization to progression or death from any cause whichever comes first, censored after three years of maintenance therapy ]
   Response Evaluation by IMWG criteria

Secondary Outcome Measures :

1. to compare the four treatment arms (IA-IIA, IA-IIB, IB-IIA, IB-IIB) regarding Progression free survival (PFS) [ Time Frame: time from 1. randomization (study inclusion) to progression or death whichever comes first (assessed up to 79 months) ]
   Response evaluation by IMWG criteria
2. to compare all 4 treatment arms (IA-IIA, IA-IIB, IB-IIA, IB-IIB) regarding overall survival (OS) from time of 1.randomization [ Time Frame: time from randomisation to time of death from any cause (assessed up to 79 months) ]
   survival status
3. Overall survival from second randomization [ Time Frame: time from 2. randomization to time of death from any cause (assessed up to 75 months) ]
   survival status
4. Complete Response (CR) rates after induction therapy [ Time Frame: After induction treatment (18 weeks after start of treatment) ]
   Response Evaluation by IMWG criteria
5. Complete Response (CR) after high dose therapy [ Time Frame: After high dose therapy (9 or 12 months after start of therapy) ]
   Response Evaluation by IMWG criteria
6. Complete Response (CR) during/after maintenance therapy [ Time Frame: During/after maintenance therapy (6 months after start of therapy up to 36 months of maintenance therapy) ]
   Response Evaluation by IMWG criteria
7. MRD negativity after high dose therapy [ Time Frame: After high dose therapy (9 or 12 months after start of therapy) ]
   Detection of minimal residual disease by flow cytometry (sensitivity at least 1e-5)
8. MRD negativity during and after maintenance therapy [ Time Frame: up to 36 months after start of maintenance therapy ]
   Detection of minimal residual disease by flow cytometry (sensitivity at least 1e-5)
9. Best response to treatment during the trial [ Time Frame: response assessment after 3 months, 4,5 months, 5,5 months, 9 months (if applicable: 3 months later after 2. high dose therapy) subsequently every 3 months during maintenance treatment, up to 48 months after start of study treatment ]
   Response evaluation by IMWG criteria
10. PFS 2 (PFS after next line of therapy) from 2. randomization [ Time Frame: time from 2. randomization to time of overall end of trial (up to 75 months) ]
    Response evaluation by IMWG criteria
11. Toxicity during induction and maintenance with respect to adverse events of CTC grade >3 (and specific adverse events of CTC grade > 2 as defined in the protocol and serious adverse events [ Time Frame: : from first administration of study drug until 30 days after last administration of study drug or any drug of the study treatment or upon start of a new subsequent chemotherapy, whichever occurs first ]
    toxicity according CTCAE Version v5.0
12. Quality of Life Assessment [ Time Frame: assessed at baseline, after ca. 4.5 months, 9 months, (additionally after 12 months,if a second high dose therapy is administered) after 12 months of maintenance and at end of study (up to 50 months) ]
    EORTC (European Organization of Research and Treatment of Cancer) -QLQC30 Questionnaire to assess the quality of life of cancer patients. Impairment of daily life is asked in 4 scales from "not at all" (best) to "very much" (worst scale), EORTC-QLQMY20 questionnaire to assess health-related quality of life in patients with multiple myeloma with 4 scales from "not at all (best scale) to "very much" (worst scale); EQ(EuroQol Group)-5D-5L Health questionnaire comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Additionally a visual analogue scale from 100 (best) to 0 (worst scale) is used to assess the quality of health questionnaires.
13. Pharmakokinetic analyses of Isatuximab in induction treatment of patients in Arm IB (selected sites only) [ Time Frame: Up to 18 weeks in induction treatment (C1: D1, before infusion, at end of infusion, 1 h after infusion, C1 D8,15,22,29 before infusion; C2 and 3:D1 before infusion ]
    Determination of serum concentration of isatuximab at different timepoints before, during and after isatuximab infusion
14. Pharmakokinetic analyses of Isatuximab in maintenance treatment of patients in Arm IIB (selected sites only) [ Time Frame: Up to 9 months (C1: D1, before infusion, at end of infusion, 1 h after infusion, C1 D8,15,22 before infusion, C2 -9, D1: before infusion ]
    Determination of serum concentration of isatuximab at different timepoints

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Confirmed diagnosis of untreated multiple myeloma requiring systemic therapy (diagnostic criteria (IMWG updated criteria (2014)1) see appendix IA. For some patients systemic therapy may be required though these diagnostic criteria are not fulfilled. In this case the GMMG study office has to be consulted prior to inclusion.)
2. Patient is eligible for high dose therapy and autologous stem cell transplantation.

3. Measurable disease, defined as any quantifiable monoclonal protein value, defined by at least one of the following three measurements:2

   • Serum M-protein ≥ 10g/l (for IgA ≥ 5g/l)
   • Urine light-chain (M-protein) of ≥ 200 mg/24 hours
   • Serum FLC assay: involved FLC level ≥ 10 mg/dl provided sFLC ratio is abnormal
4. Age 18 - 70 years inclusive
5. WHO performance status 0-2
6. Negative pregnancy test at inclusion (females of childbearing potential)
7. All patients must agree on the requirements regarding the lenalidomide pregnancy prevention plan described in section 6. For all men and females of childbearing potential: patients must be willing and capable to use adequate contraception during the complete therapy.

8. All patients must

   • agree to abstain from donating blood while taking lenalidomide and for 28 days following discontinuation of lenalidomide therapy
   • agree not to share study drug lenalidomide with another person and to return all unused study drug to the investigator or pharmacist
9. Ability of patient to understand character and individual consequences of the clinical trial
10. Provide written informed consent (must be available before enrolment in the trial)

Exclusion Criteria

1. Patient has known hypersensitivity (or contraindication) to dexamethasone, sucrose histidine (as base and hydrochloride salt), boron, mannitol, and polysorbate 80 or any of the components of study therapy that are not amenable to premedication with steroids or H2 blockers that would prohibit further treatment with these agents.
2. Systemic AL amyloidosis (except for AL amyloidosis of the skin or the bone marrow)
3. Plasma cell leukemia
4. Previous chemotherapy or radiotherapy during the past 5 years except local radiotherapy in case of local myeloma progression. (Note: patients may have received a cumulative dose of up to 160 mg of dexamethasone or equivalent as emergency therapy.) Previous therapy due to smouldering myeloma may be acceptable. In this case the GMMG study office has to be consulted prior to inclusion
5. Severe cardiac dysfunction (NYHA classification III-IV), ejection fraction < 40%
6. Significant hepatic dysfunction (ASAT and/or ALAT ≥ 3 times normal level and/or serum bilirubin ≥ 1.5 times normal level if not due to hereditary abnormalities as Gilbert's disease), unless related to myeloma.
7. Patients with active or history of hepatitis B or C
8. HIV positivity
9. Patients with active, uncontrolled infections
10. Patients with severe renal insufficiency (Creatinine Clearance < 30ml/min)
11. Patients with peripheral neuropathy or neuropathic pain, CTC grade 2 or higher (as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0)
12. Patients with a history of active malignancy during the past 5 years with the exception of following malignancies after curative therapy: basal cell carcinoma of the skin, squamous cell skin carcinoma, stage 0 cervical carcinoma or any in situ malignancy
13. Patients with acute diffuse infiltrative pulmonary and/or pericardial disease
14. Autoimmune hemolytic anemia with positive Coombs test or immune thrombocytopenia
15. Platelet count < 75 x 109/l
16. Haemoglobin < 8.0 g/dl, unless related to myeloma
17. Absolute neutrophil count (ANC) < 1.0 x 109/l (the use of colony stimulating factors within 14 days before the test is not allowed)
18. Corrected serum calcium > 14 mg/dl (> 3.5 mmol/l)
19. Unable or unwilling to undergo thromboprophylaxis
20. Pregnancy and lactation
21. Participation in other clinical trials. This does not include long-term follow-up periods without active drug treatment of previous studies during the last 6 months.
22. Prisoners or subjects who are legally institutionalized, or those unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.

No patients will be allowed to enrol in this trial more than once.

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Contacts and Locations

Locations

Germany

Uniklinik RWTH Aachen, Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzelltransplantation

Aachen, Germany, 52074

Studienzentrum Aschaffenburg

Aschaffenburg, Germany, 63739

Helios Klinikum Bad Saarow, Klinik für Hämatologie, Onkologie und Palliativmedizin

Bad Saarow, Germany, 15526

Charité, Campus Benjamin Franklin , III. Medizinische Abteilung (Hämatologie/Onkologie)

Berlin, Germany, 12200

Vivantes Klinikum Neukölln, Klinik für Hämatologie und Onkologie

Berlin, Germany, 12351

HELIOS Klinikum, Klinik für Hämatologie, Onkologie und Immunologie

Berlin, Germany, 13125

Studiengesellschaft Onkologie Bielefeld GbR

Bielefeld, Germany, 33604

Klinikum Bielefeld, Klinik für Hämatologie, Onkologie und Palliativmedizin

Bielefeld, Germany, D-33604

Medizinische Universitätsklinik, Knappschaftskrankenhaus

Bochum, Germany, D-44892

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik III, Schwerpunkt Onkologie, Hämatologie und Rheumatologie

Bonn, Germany, 53105

Johanniter Krankenhaus Bonn

Bonn, Germany, 53113

Zentrum für ambulante Hämatologie und Onkologie (ZAHO)

Bonn, Germany, 53113

Städtisches Klinikum Braunschweig, Med. Klinik III, Hämatologie und Onkologie

Braunschweig, Germany, 38114

Klinikum Chemnitz GmbH, Innere Medizin III

Chemnitz, Germany, D-09116

Carl-Thiem-Klinikum Cottbus gGmbH, II. Medizinische Klinik

Cottbus, Germany, 03048

Onkologisches Studienzentrum Darmstadt

Darmstadt, Germany, 64283

Klinikum Darmstadt, Med. Klinik V, Hämatologie/Onkologie

Darmstadt, Germany, D-64283

Universitätsklinikum Carl Gustav Carus Dresden, an der Technischen Universität Dresden, Medizinische Klinik und Poliklinik I

Dresden, Germany, 01307

HELIOS St. Johannes Klinik, Akademisches Krankenhaus der Heinrich-Heine-Universität Düsseldorf

Duisburg, Germany, 47166

Marien Hospital Düsseldorf GmbH, Klinik für Onkologie, Hämatologie und Palliativmedizin

Düsseldorf, Germany, 40479

Universitätsklinikum Düsseldorf, Klinik für Hämatologie,Onkologie und Klin. Immunologie

Düsseldorf, Germany, D-40225

Universitätsklinik Erlangen

Erlangen, Germany, 91054

St. Antonius-Hospital Eschweiler, Klinik für Hämatologie / Onkologie

Eschweiler, Germany, 52249

Universitätsklinikum Essen, Klinik für Hämatologie

Essen, Germany, D-45147

Ev. Krankenhaus Essen-Werden gGmbH, Zentrum für Innere Medizin, Klinik für Hämatologie, Onkologie und Stammzelltransplantation

Essen, Germany, D-45239

Gemeinschaftspraxis Prof. Dr. Michael Kiehl und Dipl. Med. Wolfgang Stein

Frankfurt (Oder), Germany, 15236

Klinikum Frankfurt (Oder) GmbH

Frankfurt (Oder), Germany, 15236

Centrum für Hämatologie und Onkologie Bethanien

Frankfurt am Main, Germany, 60389

Agaplesion Markus Krankenhaus, Med. Klinik I

Frankfurt am Main, Germany, 60431

Krankenhaus Nordwest, Institut für Klinisch-Onkologische Forschung

Frankfurt am Main, Germany, 60488

Universitätsklinikum Frankfurt, Goethe-Universität Medizinische Klinik II

Frankfurt am Main, Germany, 60590

Klinikum Fulda, Klinisches Studienzentrum GmbH

Fulda, Germany, 36043

Universitätsklinik der Justus-Liebig-Universität, Medizinische Klinik IV

Gießen, Germany, 35385

Katholisches Karl-Leisner-Klinikum gGmbH, Wilhelm-Anton-Hospital Goch, Klinik für Hämatologie - Onkologie

Goch, Germany, 47574

Kath. Krankenhaus Hagen gGmbH, Abt. Hämatologie/Onkologie

Hagen, Germany, D-58095

Asklepios Klinik Hamburg St. Georg

Hamburg, Germany, 20099

Universitätsklinikum Hamburg Eppendorf, Zentrum für Onkologie, Studienzentrale der II. Medizinischen Klinik

Hamburg, Germany, 20246

Asklepios Klinik Hamburg Altona, II. Med. Klinik

Hamburg, Germany, D-22763

Immunologisch-onkologisches MVZ am Siloah Krankenhaus

Hannover, Germany, 30449

KRH Klinikum Siloah, Klinik für Hämatologie und Onkologie

Hannover, Germany, 30459

Onkologische Schwerpunktpraxis Heidelberg

Heidelberg, Germany, 69115

Krankenhaus St. Vincentius der evangelischen Stadtmission Heidelberg, Abt. Hämatologie, Onkologie, Rheumatologie

Heidelberg, Germany, 69117

University Hospital Heidelberg, Med. Klinik V

Heidelberg, Germany, D-69120

SLK Kliniken Heilbronn, Med. Klinik III

Heilbronn, Germany, D-74078

Marien Hospital Herne

Herne, Germany, 44625

Universitätsklinikum des Saarlandes, Innere Medizin I

Homburg (Saar), Germany, 66421

Westpfalz-Klinikum GmbH, Klinik für Innere Medizin I

Kaiserslautern, Germany, 67655

Städtisches Klinikum Karlsruhe

Karlsruhe, Germany, 76133

Praxisklinik für Hämatologie und Onkologie

Koblenz, Germany, D-56068

Uniklinik Köln, Klinik I für Innere Medizin

Köln, Germany, 50937

Gemeinschaftspraxis für Hämatologie und Onkologie am Caritas Krankenhaus

Lebach, Germany, 66822

Universitätsklinikum Leipzig AöR, Medizinische Klinik und Poliklinik I-Hämatologie und Zelltherapie, Internistische Onkologie, Hämostaseologie

Leipzig, Germany, 04103

Med. Klinik A, Klinikum der Stadt Ludwigshafen am Rhein gGmbH

Ludwigshafen am Rhein, Germany, 67063

Universitätsmedizin der Johannes Gutenberg-Universität Mainz, III. Med. Klinik

Mainz, Germany, D-55131

III. Medizinische Klinik Hämatologie und Internistische Onkologie

Mannheim, Germany, 68167

Mannheimer Onkologie Praxis

Mannheim, Germany, D-68161

Philipps-Universität Marburg, Hämatologie/Onkologie/Immunologie

Marburg, Germany, 35032

Mühlenkreiskliniken (AöR) Johannes Wesling Klinikum Minden, Hämatologie/Onkologie, Hämostaseologie und Palliativmedizin

Minden, Germany, 32429

Krankenhaus Maria Hilf GmbH, Franziskuskrankenhaus, Med. Klinik I

Mönchengladbach, Germany, D-41063

Universitätsklinikum Münster, Med. Klinik A

Münster, Germany, 48149

Klinikum Osnabrück GmbH

Osnabrück, Germany, 49076

Brüderkrankenhaus St. Josef Paderborn, Klinik für Hämatologie und Onkologie

Paderborn, Germany, 33098

Krankenhaus Barmherzige Brüder, Klinik für Onkologie und Hämatologie

Regensburg, Germany, 93049

Gemeinschaftspraxis für Hämatologie und Onkologie, Onkologisches Zentrum

Saarlouis, Germany, 66740

Diakonie-Klinikum Schwäbisch Hall gGmbH, Innere Medizin III

Schwäbisch Hall, Germany, 74523

ZAHO-Zentrum für ambulante Hämatologie und Onkologie, Standort Siegburg

Siegburg, Germany, D-53721

Onkologische Schwerpunktpraxis Speyer

Speyer, Germany, D-67346

Klinikum Stuttgart, Stuttgart Cancer Center, Tumorzentrum Eva Mayr-Stihl

Stuttgart, Germany, 70174

Klinikum Mutterhaus der Borromäerinnen gGmbH

Trier, Germany, 54290

University Hospital Tübingen, Med. Klinik und Poliklinik, Abt. II

Tübingen, Germany, D-72076

Bundeswehrkrankenhaus Ulm, Abteilung Innere Medizin - Hämatologie und internistische Onkologie

Ulm, Germany, 89081

Schwarzwald-Baar Klinikum, Innere Medizin II

Villingen-Schwenningen, Germany, 78052

Rems-Murr-Kliniken gGmbH

Winnenden, Germany, 71364

Sponsors and Collaborators

University of Heidelberg Medical Center

Investigators

• Principal Investigator: Hartmut Goldschmidt, Prof. Dr.; Med. Klinik V, University Hospital Heidelberg

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Goldschmidt H, Mai EK, Bertsch U, Fenk R, Nievergall E, Tichy D, Besemer B, Durig J, Schroers R, von Metzler I, Hanel M, Mann C, Asemissen AM, Heilmeier B, Weinhold N, Huhn S, Kriegsmann K, Luntz SP, Holderried TAW, Trautmann-Grill K, Gezer D, Klaiber-Hakimi M, Muller M, Khandanpour C, Knauf W, Scheid C, Munder M, Geer T, Riesenberg H, Thomalla J, Hoffmann M, Raab MS, Salwender HJ, Weisel KC; German-Speaking Myeloma Multicenter Group (GMMG) HD7 investigators. Addition of isatuximab to lenalidomide, bortezomib, and dexamethasone as induction therapy for newly diagnosed, transplantation-eligible patients with multiple myeloma (GMMG-HD7): part 1 of an open-label, multicentre, randomised, active-controlled, phase 3 trial. Lancet Haematol. 2022 Nov;9(11):e810-e821. doi: 10.1016/S2352-3026(22)00263-0.

• Responsible Party: Prof. Dr. Hartmut Goldschmidt, Head of Division of Multiple Myeloma, University of Heidelberg Medical Center
• ClinicalTrials.gov Identifier: NCT03617731
• Other Study ID Numbers: GMMG HD7
• First Posted: August 6, 2018
• Last Update Posted: May 12, 2023
• Last Verified: May 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Dexamethasone; Lenalidomide; Bortezomib; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors