A Trial to Learn How Well Linvoseltamab Works Compared to the Combination of Elotuzumab, Pomalidomide and Dexamethasone for Adult Participants With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)

• ClinicalTrials.gov Identifier: NCT05730036
• Recruitment Status: Recruiting
• First Posted: February 15, 2023
• Last Update Posted: April 30, 2024
• Sponsor: Regeneron Pharmaceuticals
• Information provided by (Responsible Party): Regeneron Pharmaceuticals

Study Description

Brief Summary:

This study is researching an experimental drug called linvoseltamab, also called REGN5458.

Linvoseltamab has previously been studied by itself (without other cancer drugs) in participants who had advanced multiple myeloma that returned and needed to be treated again after many other therapies had failed. These participants were no longer benefiting from standard medications and had no good treatment options. In that study, some participants who were treated with linvoseltamab had improvement of their myeloma (shrinkage of their tumors), including some participants who had complete responses (that is, the treatment got rid of all evidence of myeloma in their bodies).

This study is focused on participants who have multiple myeloma that has returned or needs to be treated again after one to four prior treatments and have standard cancer treatment options available to them. The aim of this study is to see how safe and effective linvoseltamab is compared to a combination of three cancer drugs: elotuzumab, pomalidomide and dexamethasone, (called EPd) in participants who have returned after having received prior treatment that included lenalidomide, a proteosome inhibitor, and (for participants in some countries) a cluster of differentiation 38 (CD38) antibody. Half of the participants in this study will get linvoseltamab, and the other half will get EPd.

This study is looking at several other research questions, including:

• How long participants benefit from receiving linvoseltamab compared with EPd
• How many participants treated with linvoseltamab or EPd have improvement of their multiple myeloma and by how much
• What side effects happen from taking linvoseltamab compared to EPd
• How long participants live while receiving treatment or after treatment with linvoseltamab compared to EPd
• If there is any improvement in pain after treatment with linvoseltamab compared to EPd

Condition or disease	Intervention/treatment	Phase
Relapsed Refractory Multiple Myeloma (RRMM)	Drug: Linvoseltamab; Drug: Elotuzumab; Drug: Pomalidomide; Drug: Dexamethasone	Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 380 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Randomized, Phase 3 Study of Linvoseltamab (REGN5458; Anti- BCMA x Anti-CD3 Bispecific Antibody) Versus the Combination of Elotuzumab, Pomalidomide, and Dexamethasone (EPd), in Patients With Relapsed/Refractory Multiple Myeloma (LINKER-MM3)
• Actual Study Start Date: September 18, 2023
• Estimated Primary Completion Date: December 26, 2032
• Estimated Study Completion Date: December 26, 2032

Arms and Interventions

Arm	Intervention/treatment
Experimental: Linvoseltamab; Randomization 1:1	Drug: Linvoseltamab; REGN5458 will be administered by intravenous (IV) infusion; Other Name: REGN5458
Active Comparator: Elotuzumab/Pomalidomide/Dexamethasone (EPd); Randomization 1:1	Drug: Elotuzumab; Elotuzumab will be administered by IV infusion; Other Name: Empliciti; Drug: Pomalidomide; Pomalidomide capsules will administered by mouth (PO); Other Name: Pomalyst; Drug: Dexamethasone; Dexamethasone tablets/capsules will be administered PO and/or by IV infusion; Other Name: Decadron

Outcome Measures

Primary Outcome Measures :

1. Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants [ Time Frame: Up to approximatively 5 years ]

Secondary Outcome Measures :

1. PFS per IMWG response criteria determined by IRC in all participants [ Time Frame: Up to approximatively 5 years ]
2. Objective Response (OR) of Partial Response (PR) or better per IMWG response criteria as determined by the IRC in CD38 antibody exposed participants [ Time Frame: Up to approximatively 5 years ]
3. OR of PR or better per IMWG response criteria as determined by the IRC in all participants [ Time Frame: Up to approximatively 5 years ]
4. OR of Very Good Partial Response (VGPR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants [ Time Frame: Up to approximatively 5 years ]
5. OR of VGPR or better per IMWG response criteria as determined by IRC in all participants [ Time Frame: Up to approximatively 5 years ]
6. OR of Complete Response (CR) or better per IMWG response criteria as determined by IRC in CD38 antibody exposed participants [ Time Frame: Up to approximatively 5 years ]
7. OR of CR or better per IMWG response criteria as determined by IRC in all participants [ Time Frame: Up to approximatively 5 years ]
8. Incidence of minimal residual disease (MRD) negative status in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
9. Incidence of MRD negative status in all participants [ Time Frame: Up to approximatively 5 years ]
10. Overall Survival (OS) in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
11. OS in all participants [ Time Frame: Up to approximatively 5 years ]
12. Mean change in the worst pain score measured by Brief Pain Inventory-Short Form (BPI-SF) Item 3 in participants previously exposed to CD38 antibodies [ Time Frame: Baseline to week 12 ]
    The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain.
13. Mean change in the worst pain score measured by BPI-SF Item 3 in all participants [ Time Frame: Baseline to week 12 ]
    The BPI-SF is a validated, self-administered questionnaire designed to measure a participant's perceived level of pain. The BPI-SF Item 3 uses a numeric rating scale to assess pain severity and pain interference in the past 24 hours. The numeric rating scale ranges from 0 (no pain) to 10 (worst imaginable pain), where higher scores indicate greater intensity of pain.
14. Incidence of treatment emergent adverse events (TEAEs) in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
15. Incidence TEAEs in all participants [ Time Frame: Up to approximatively 5 years ]
16. Severity of TEAEs in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
17. Severity of TEAEs in all participants [ Time Frame: Up to approximatively 5 years ]
18. Incidence of adverse events of special interest (AESI) in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
19. Incidence of AESI in all participants [ Time Frame: Up to approximatively 5 years ]
20. Severity of AESI in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
21. Severity AESI in all participants [ Time Frame: Up to approximatively 5 years ]
22. Incidence of Serious Adverse Events (SAE) in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
23. Incidence of SAE in all participants [ Time Frame: Up to approximatively 5 years ]
24. Severity of SAE in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
25. Severity of SAE in all participants [ Time Frame: Up to approximatively 5 years ]
26. PFS per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
27. PFS per IMWG response criteria as determined by the investigator in all participants [ Time Frame: Up to approximatively 5 years ]
28. OR of PR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
29. OR of PR or better per IMWG response criteria as determined by the investigator in all participants [ Time Frame: Up to approximatively 5 years ]
30. OR of VGPR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
31. OR of VGPR or better per IMWG response criteria as determined by the investigator in all participants [ Time Frame: Up to approximatively 5 years ]
32. OR of CR or better per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
33. OR of CR or better per IMWG response criteria as determined by the investigator in all participants [ Time Frame: Up to approximatively 5 years ]
34. Duration of Response (DoR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
35. DoR as per IMWG response criteria as determined by the investigator in all participants [ Time Frame: Up to approximatively 5 years ]
36. DoR as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
37. DoR as per IMWG response criteria as determined by the IRC in all participants [ Time Frame: Up to approximatively 5 years ]
38. Duration of MRD negative status in the bone marrow in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
39. Duration of MRD negative status in the bone marrow in all participants [ Time Frame: Up to approximatively 5 years ]
40. Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
41. Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the investigator in all participants [ Time Frame: Up to approximatively 5 years ]
42. Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the IRC in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
43. Time from randomization to objective response (≥PR) as per IMWG response criteria as determined by the IRC in all participants [ Time Frame: Up to approximatively 5 years ]
44. Concentration of linvoseltamab in the serum over time in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
45. Concentration of linvoseltamab in the serum over time in all participants [ Time Frame: Up to approximatively 5 years ]
46. Incidence of antidrug antibodies (ADAs) in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
47. Incidence of ADAs in all participants [ Time Frame: Up to approximatively 5 years ]
48. Titer of ADAs in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
49. Titer of ADAs in all participants [ Time Frame: Up to approximatively 5 years ]
50. Incidence of neutralizing antibodies (Nabs) to linvoseltamab over time in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
51. Incidence of Nabs to linvoseltamab over time in all participants [ Time Frame: Up to approximatively 5 years ]
52. Proportion of Pain Responders in participants previously exposed to CD38 antibodies [ Time Frame: At week 12 ]
    Defined by at least a 2-point reduction from baseline in the BPI-SF Item 3 without an increase in analgesic use using the modified Analgesic Quantification Algorithm (AQA).
53. Proportion of Pain Responders in all participants [ Time Frame: At week 12 ]
    Defined by at least a 2-point reduction from baseline in the BPI-SF Item 3 without an increase in analgesic use using the modified Analgesic Quantification Algorithm (AQA).
54. Change in patient-reported global health status/quality of life (QoL), per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in participants previously exposed to CD38 antibodies [ Time Frame: Baseline to week 12 ]
    The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
55. Change in patient-reported QoL, per EORTC QLQ-C30 in all participants [ Time Frame: Baseline to week 12 ]
    The EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including global health status/quality of life, functional Scales (physical, role, emotional, cognitive, and social), symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Participants rate items on a 4-point scale, with 1 as "not at all" and 4 as "very much."
56. Change in patient reported disease symptoms per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20]) in participants previously exposed to CD38 antibodies [ Time Frame: Baseline to week 12 ]
    The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.
57. Change in patient reported disease symptoms per EORTC QLQ-MY20 in all participants [ Time Frame: Baseline to week 12 ]
    The EORTC QLQ-MY20 is a self -administered instrument to assess QoL in persons with MM. This 20-item questionnaire measures the following domains: symptom scales, including disease symptoms (6 items) and symptoms related to side effects of treatment (10 items); function scale and future perspective (3 items); and body image (1 item). A high score represents a high level of symptoms or problems.
58. Patient-Reported Outcomes in Patient Global Impression of Symptom Severity (PGIS) in participants previously exposed to CD38 antibodies [ Time Frame: Baseline to week 12 ]

    The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".

    The global anchor, PGIS will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.

59. Patient-Reported Outcomes in PGIS in all participants [ Time Frame: Baseline to week 12 ]

    The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".

    The global anchor, PGIS will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.

60. Patient-Reported Outcomes in Patient Global Impression of Change (PGIC) in participants previously exposed to CD38 antibodies [ Time Frame: Baseline to week 12 ]

    The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change".

    The global anchor, PGIC will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.

61. Patient-Reported Outcomes in PGIC in all participants [ Time Frame: Baseline to week 12 ]

    The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change".

    The global anchor, PGIC will be used for interpretation of EORTC QLQ-C30, EORTC QLQ-MY20, and BPI-SF.

62. Change in patient-reported general health status per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) in participants previously exposed to CD38 antibodies [ Time Frame: Baseline to week 12 ]
    The EQ-5D-5L consists of EQ-5D descriptive system 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.
63. Change in patient-reported general health status per EQ-5D-5L in all participants [ Time Frame: Baseline to week 12 ]
    The EQ-5D-5L consists of EQ-5D descriptive system 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.

Eligibility Criteria

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

Criteria

Key Inclusion Criteria:

1. Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1. Patients with ECOG 2 solely due to local symptoms of myeloma (eg. pain) may be allowed after discussion with the Medical Monitor.

3. Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol.

   Note: Participants in Israel also must have previously received a CD38 antibody. Participants in the EU and the UK must have previously received 2 to 4 prior lines of therapy, including a CD38 antibody.

4. Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
5. Adequate hematologic, hepatic, renal and cardiac function, as well as evidence of adequate bone marrow reserves
6. Life expectancy of at least 6 months

Key Exclusion Criteria:

1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
2. Prior treatment with elotuzumab and/or pomalidomide
3. Participants with known MM brain lesions or meningeal involvement
4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
5. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.
6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
7. History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder.
8. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
9. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol.

NOTE: Other protocol defined inclusion/exclusion criteria apply

Contacts and Locations

Contacts

Contact: Clinical Trials Administrator; 844-734-6643; clinicaltrials@regeneron.com

Locations

United States, California

UCLA; Recruiting

Los Angeles, California, United States, 90095

United States, Kentucky

Norton Cancer Institute - St. Matthews Campus; Recruiting

Louisville, Kentucky, United States, 40207

United States, New York

Stony Brook University Hospital; Recruiting

Stony Brook, New York, United States, 11794

United States, North Carolina

Levine Cancer Center; Recruiting

Charlotte, North Carolina, United States, 28204

United States, Oregon

Kaiser Permanente Northwest; Recruiting

Portland, Oregon, United States, 97227

United States, Washington

University of Washington-Seattle Cancer Care Alliance; Recruiting

Seattle, Washington, United States, 98109

Australia, New South Wales

Royal Prince Alfred Hospital; Recruiting

Camperdown, New South Wales, Australia, 2050

Royal North Shore Hospital; Recruiting

St Leonards, New South Wales, Australia, 2065

Australia, Queensland

Royal Brisbane Hospital; Recruiting

Herston, Queensland, Australia, 4029

Integrated Clinical Oncology Network; Recruiting

South Brisbane, Queensland, Australia, 4101

Australia, Victoria

University Hospital Geelong; Recruiting

Geelong, Victoria, Australia, 3220

Austin Hospital; Recruiting

Heidelberg, Victoria, Australia, 3084

St Vincents Hospital Melbourne; Recruiting

Melbourne, Victoria, Australia, 3065

Brazil

Hospital Sao Rafael; Recruiting

Salvador, Bahia, Brazil, 41253-190

Associacao Dr Bartholomeu Tacchini (Instituto Tacchini De Pesquisa Em Saude); Recruiting

Bento Goncalves, Rio Grade Do Sul, Brazil, 95700084

Hospital Mae de Deus Center; Recruiting

Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270

ANIMI; Recruiting

Lages, Santa Catarina, Brazil, 88501-001

Canada, Ontario

The Ottawa Hospital; Recruiting

Ottawa, Ontario, Canada, K1H 8L6

University Health Network (UHN) - Princess Margaret Cancer Centre; Recruiting

Toronto, Ontario, Canada, M5G 2M9

France

Institut Gustave Roussy-Gustave Roussy Cancer Center -DITEP; Recruiting

Villejuif, Paris, France, 94800

Centre Hospitalier Universitaire (CHU) de Lille; Recruiting

Lille, France, 59037

Hopital Universitaire Necker; Recruiting

Paris, France, 75015

Israel

The Chaim Sheba Medical Center; Recruiting

Ramat Gan, Hamerkaz, Israel, 5265601

Rambam health care Campus; Recruiting

Haifa, Israel, 3109601

Carmel Medical Center; Recruiting

Haifa, Israel, 3436212

Shaare Zedek Medical Center; Recruiting

Jerusalem, Israel, 91031

Hadassah Medical Center; Recruiting

Jerusalem, Israel, 91120

Tel Aviv Sourasky Medical Center; Recruiting

Tel Aviv, Israel, 64239

Italy

Istituto Romagnolo per lo Studio Dei Tumori "Dino Amadori"; Recruiting

Meldola, Forli Cesena, Italy, 47014

AOU Ospedali Riuniti di Ancona; Recruiting

Ancona, Italy, 60126

IRCCS Fondazione Policlinico San Matteo Pavia; Recruiting

Pavia, Italy, 27100

U.O.C. Ematologia Ospedale Santa Maria delle Croci; Recruiting

Ravenna, Italy, 48121

AUSL IRCCS OF Reggio Emilia; Recruiting

Reggio Emilia, Italy, 42123

University of Torino, Division of Hematology; Recruiting

Torino, Italy, 10126

Candiolo Cancer Institute, FPO, IRCCS; Recruiting

Turin, Italy, 10060

Korea, Republic of

Inje University Busan Paik Hospital; Recruiting

Busan, Korea, Republic of, 47392

Pusan National University Hospital; Recruiting

Busan, Korea, Republic of, 49241

Chonnam National University Hwasun Hospital; Recruiting

Hwasun, Korea, Republic of, 58128

Gachon University Gil Medical Center; Recruiting

Incheon, Korea, Republic of, 28265

Jeonbuk National University Hospital; Recruiting

Jeonju, Korea, Republic of, 54907

Seoul National University Hospital; Recruiting

Seoul, Korea, Republic of, 03080

Severance Hospital; Recruiting

Seoul, Korea, Republic of, 03722

Asan Medical Center; Recruiting

Seoul, Korea, Republic of, 05505

Samsung Medical Center; Recruiting

Seoul, Korea, Republic of, 06351

The Catholic University of Korea Seoul St. Marys Hospital; Recruiting

Seoul, Korea, Republic of, 06591

Poland

Pratia Onkologia Katowice; Recruiting

Katowice, Poland, 40-519

Singapore

Singapore General Hospital; Recruiting

Singapore, Singapore, 169856

Spain

Hospital de Cabueñes; Recruiting

Gijon, Asturias, Spain, 33203

Hospital Universitario Central de Asturias; Recruiting

Oviedo, Asturias, Spain, 33011

Hospital universitari Son LLatzer; Recruiting

Palma de Mallorca, Baleares, Spain, 07198

Institut Catala dOncologia, Hospital Germans Trias i Pujol; Recruiting

Badalona, Barcelona, Spain, 08916

Hospital Universitari Son Espases; Recruiting

Palma de Mallorca, Islas Baleares, Spain, 07120

Hospital Universitario Quirónsalud Madrid; Recruiting

Pozuelo, Madrid, Spain, 28223

Hospital Universitario de Navarra; Recruiting

Pamplona, Navarra, Spain, 31008

Hospital Gral. Universitari D'Alacant Y C.E Babel (Hospital General De Alicante); Recruiting

Alicante, Spain, 03010

Hospital Clinic de Barcelona; Recruiting

Barcelona, Spain, 08036

Universitary Hospital La Princesa; Recruiting

Madrid, Spain, 28006

Clinica Universidad de Navarra - Sede Madrid; Recruiting

Madrid, Spain, 28027

Hospital Fundación Jimenez Diaz; Recruiting

Madrid, Spain, 28040

University Hospital La Fe; Recruiting

Valencia, Spain, 46026

Hospital Clinico Universitario Lozano Blesa de Zaragoza; Recruiting

Zaragoza, Spain, 50009

Taiwan

Kaohsiung Medical University Hospital; Recruiting

Kaohsiung, Taiwan, 807

Chang Gung Memorial Hospital- Linkou Branch; Recruiting

Taoyuan, Taiwan, 333

United Kingdom

Royal Marsden Hospital (Sutton) - Royal Marsden NHS Foundation Trust; Recruiting

Sutton, Surrey, United Kingdom, SM2 5PT

Guy's Hospital - Guy's & St Thomas' NHS Foundation Trust; Recruiting

London, United Kingdom, SE1 9RT

Hammersmith Hospital, Imperial College Healthcare NHS Trust; Recruiting

London, United Kingdom, W12 0HS

Sponsors and Collaborators

Regeneron Pharmaceuticals

Investigators

• Study Director: Clinical Trial Management; Regeneron Pharmaceuticals

More Information

• Responsible Party: Regeneron Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT05730036
• Other Study ID Numbers: R5458-ONC-2245; 2022-501396-62-00 ( Other Identifier: EUCT Number )
• First Posted: February 15, 2023
• Last Update Posted: April 30, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code
• Time Frame: When Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication, has made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry), has the legal authority to share the data, and has ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
• URL: https://vivli.org/

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

Keywords provided by Regeneron Pharmaceuticals:

BCMA X CD3 Bispecific Monoclonal Antibody; CD38 antibody; Proteasome inhibitor; Lenalidomide

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; Pomalidomide; Elotuzumab; 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