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

JRCT ID: jRCT2061240057

Registered date:18/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Relapsed Refractory Multiple Myeloma
• Date of first enrollment: 31/10/2024
• Target sample size: 38
• Countries of recruitment: United States,Japan,Canada,Japan,Belgium,Japan,France,Japan,Germany,Japan,Italy,Japan,Spain,Japan,Netherlands,Japan,Poland,Japan,United Kingdom,Japan,South Korea,Japan,Australia,Japan,Taiwan,Japan,Singapore,Japan,Israel,Japan,Brazil,Japan,Chile,Japan,Ireland,Japan,Austria,Japan,Romania,Japan
• Study type: Interventional

Intervention(s)

Drug: Linvoseltamab (REGN5458) will be administered by intravenous (IV) infusion
Drug: Elotuzumab will be administered by IV infusion
Drug: Pomalidomide capsules will administered by mouth (PO)
Drug: Dexamethasone tablets/capsules will be administered PO and/or by IV infusion

Outcome(s)

• Primary Outcome: Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 exposed participants [Time Frame: Up to approximatively 5 years]
• Secondary Outcome: Please see Attachment.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.
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
NOTE: Other protocol defined inclusion criteria apply

Exclude criteria

1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenstroem 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 intravenous (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 exclusion criteria apply

Related Information

• Primary Sponsor: Rafael Conti, MD
• Secondary ID(s): NCT05730036,2022-501396-62-00