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

Tracking Information

• First Submitted Date: February 6, 2023
• First Posted Date: February 15, 2023
• Last Update Posted Date: April 30, 2024
• Actual Study Start Date: September 18, 2023
• Estimated Primary Completion Date: December 26, 2032 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 22, 2024): 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 ]
• Original Primary Outcome Measures (submitted: February 6, 2023): Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) [ Time Frame: Up to approximatively 5 years ]

Current Secondary Outcome Measures (submitted: April 22, 2024)

• PFS per IMWG response criteria determined by IRC in all participants [ Time Frame: Up to approximatively 5 years ]
• 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 ]
• OR of PR or better per IMWG response criteria as determined by the IRC in all participants [ Time Frame: Up to approximatively 5 years ]
• 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 ]
• OR of VGPR or better per IMWG response criteria as determined by IRC in all participants [ Time Frame: Up to approximatively 5 years ]
• 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 ]
• OR of CR or better per IMWG response criteria as determined by IRC in all participants [ Time Frame: Up to approximatively 5 years ]
• Incidence of minimal residual disease (MRD) negative status in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• Incidence of MRD negative status in all participants [ Time Frame: Up to approximatively 5 years ]
• Overall Survival (OS) in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• OS in all participants [ Time Frame: Up to approximatively 5 years ]
• 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.
• 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.
• Incidence of treatment emergent adverse events (TEAEs) in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• Incidence TEAEs in all participants [ Time Frame: Up to approximatively 5 years ]
• Severity of TEAEs in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• Severity of TEAEs in all participants [ Time Frame: Up to approximatively 5 years ]
• Incidence of adverse events of special interest (AESI) in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• Incidence of AESI in all participants [ Time Frame: Up to approximatively 5 years ]
• Severity of AESI in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• Severity AESI in all participants [ Time Frame: Up to approximatively 5 years ]
• Incidence of Serious Adverse Events (SAE) in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• Incidence of SAE in all participants [ Time Frame: Up to approximatively 5 years ]
• Severity of SAE in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• Severity of SAE in all participants [ Time Frame: Up to approximatively 5 years ]
• PFS per IMWG response criteria as determined by the investigator in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• PFS per IMWG response criteria as determined by the investigator in all participants [ Time Frame: Up to approximatively 5 years ]
• 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 ]
• OR of PR or better per IMWG response criteria as determined by the investigator in all participants [ Time Frame: Up to approximatively 5 years ]
• 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 ]
• OR of VGPR or better per IMWG response criteria as determined by the investigator in all participants [ Time Frame: Up to approximatively 5 years ]
• 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 ]
• OR of CR or better per IMWG response criteria as determined by the investigator in all participants [ Time Frame: Up to approximatively 5 years ]
• 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 ]
• DoR as per IMWG response criteria as determined by the investigator in all participants [ Time Frame: Up to approximatively 5 years ]
• 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 ]
• DoR as per IMWG response criteria as determined by the IRC in all participants [ Time Frame: Up to approximatively 5 years ]
• Duration of MRD negative status in the bone marrow in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• Duration of MRD negative status in the bone marrow in all participants [ Time Frame: Up to approximatively 5 years ]
• 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 ]
• 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 ]
• 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 ]
• 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 ]
• Concentration of linvoseltamab in the serum over time in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• Concentration of linvoseltamab in the serum over time in all participants [ Time Frame: Up to approximatively 5 years ]
• Incidence of antidrug antibodies (ADAs) in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• Incidence of ADAs in all participants [ Time Frame: Up to approximatively 5 years ]
• Titer of ADAs in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• Titer of ADAs in all participants [ Time Frame: Up to approximatively 5 years ]
• Incidence of neutralizing antibodies (Nabs) to linvoseltamab over time in participants previously exposed to CD38 antibodies [ Time Frame: Up to approximatively 5 years ]
• Incidence of Nabs to linvoseltamab over time in all participants [ Time Frame: Up to approximatively 5 years ]
• 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).
• 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).
• 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."
• 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."
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Original Secondary Outcome Measures (submitted: February 6, 2023)

• Objective Response (OR) greater or equal to Partial Response (PR) per IMWG response criteria [ Time Frame: Up to approximatively 5 years ]
  ORR will be assessed using IMWG response critieria by the IRC
• Objective Response Rate (ORR) greater or equal to Very Good Partial Response (VGPR) per IMWG response criteria as determined by IRC [ Time Frame: Up to approximatively 5 years ]
• Objective Response Rate (ORR) greater or equal to Complete Response (CR) per IMWG response criteria as determined by IRC [ Time Frame: Up to approximatively 5 years ]
• Incidence of minimal residual disease (MRD) negative status [ Time Frame: Up to approximatively 5 years ]
• Overall Survival (OS) [ Time Frame: Up to approximatively 5 years ]
• Mean change from baseline in the worst pain score measured by Brief Pain Inventory-Short Form (BPI-SF) Item 3 [ 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.
• Progression-free Survival (PFS) per IMWG response criteria as determined by the investigator [ Time Frame: Up to approximatively 5 years ]
• Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Up to approximatively 5 years ]
• Severity of treatment emergent adverse events (TEAEs) [ Time Frame: Up to approximatively 5 years ]
• Incidence of adverse events of special interest (AESI) [ Time Frame: Up to approximatively 5 years ]
• Severity of adverse events of special interest (AESI) [ Time Frame: Up to approximatively 5 years ]
• Incidence of Serious Adverse Events (SAE) [ Time Frame: Up to approximatively 5 years ]
• Severity of Serious Adverse Events (SAE) [ Time Frame: Up to approximatively 5 years ]
• ORR greater or equal to PR per IMWG response criteria [ Time Frame: Up to approximatively 5 years ]
  ORR will be assessed using IMWG response critieria by the investigator
• ORR greater or equal to VGPR per IMWG response criteria [ Time Frame: Up to approximatively 5 years ]
  ORR will be assessed using IMWG response criteria by the investigator
• ORR greater or equal to CR per IMWG response criteria [ Time Frame: Up to approximatively 5 years ]
  ORR will be assessed using IMWG response criteria by the investigator
• Duration of Response (DoR) as per IMWG response criteria [ Time Frame: Up to approximatively 5 years ]
  DoR will be assessed using IMWG response criteria by the investigator and IRC
• Duration of MRD negative status in the bone marrow [ Time Frame: Up to approximatively 5 years ]
• Time from randomization to objective response (≥PR) as per IMWG response criteria [ Time Frame: From randomization to objective response, up to approximatively 5 years ]
  As determined by IRC and investigator
• Concentration of linvoseltamab in the serum over time [ Time Frame: Up to approximatively 5 years ]
• Incidence of antidrug antibodies (ADAs) [ Time Frame: Up to approximatively 5 years ]
• Titer of antidrug antibodies (ADAs) [ Time Frame: Up to approximatively 5 years ]
• Incidence of neutralizing antibodies (NAbs) to linvoseltamab over time [ Time Frame: Up to approximatively 5 years ]
• Proportion of Pain Responders [ 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
• Change from baseline 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) [ 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."
• Change from baseline in patient reported disease symptoms per EORTC Quality of Life Questionnaire-Multiple Myeloma (MM) module 20 [QLQ-MY20]) [ 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.
• Change from baseline in Patient Global Impression of Severity (PGIS) [ 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".
• Change from baseline in Patient Global Impression of Change (PGIC) [ 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"
• Change from baseline in patient-reported general health status per EuroQoL-5 Dimension-5 Level Scale [EQ-5D-5L]) [ 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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)

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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Relapsed Refractory Multiple Myeloma (RRMM)

Intervention

• Drug: Linvoseltamab
  REGN5458 will be administered by intravenous (IV) infusion
  Other Name: REGN5458
• 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

Study Arms

• Experimental: Linvoseltamab
  Randomization 1:1
  Intervention: Drug: Linvoseltamab
• Active Comparator: Elotuzumab/Pomalidomide/Dexamethasone (EPd)
  Randomization 1:1
  Interventions:

  • Drug: Elotuzumab
  • Drug: Pomalidomide
  • Drug: Dexamethasone

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: April 22, 2024): 380
• Original Estimated Enrollment (submitted: February 6, 2023): 286
• Estimated Study Completion Date: December 26, 2032
• Estimated Primary Completion Date: December 26, 2032 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Australia, Brazil, Canada, France, Israel, Italy, Korea, Republic of, Poland, Singapore, Spain, Taiwan, United Kingdom, United States

Administrative Information

• NCT Number: NCT05730036
• Other Study ID Numbers: R5458-ONC-2245; 2022-501396-62-00 ( Other Identifier: EUCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: Informed Consent Form (ICF)
• Supporting Materials: Clinical Study Report (CSR)
• Supporting Materials: 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/

• Current Responsible Party: Regeneron Pharmaceuticals
• Original Responsible Party: Same as current
• Current Study Sponsor: Regeneron Pharmaceuticals
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trial Management; Regeneron Pharmaceuticals

• PRS Account: Regeneron Pharmaceuticals
• Verification Date: April 2024