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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT05730036
Phase
PHASE3
Status
Recruiting
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Conditions

  • Relapsed Refractory Multiple Myeloma (RRMM)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Sep 18, 2023
Status verified
Oct 2025
Primary completion
Apr 19, 2033
Completion
Apr 19, 2033

Study Design

Enrollment
410 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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 ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of California Los Angeles (UCLA)Los AngelesCalifornia90095-
University of Florida Division of Sponsored ProgramsGainesvilleFlorida32611-
University of Kentucky, Markey Cancer Center Clinical Research OrganizationLexingtonKentucky40536-
Norton Cancer InstituteLouisvilleKentucky40207-
Stony Brook UniversityStony BrookNew York11794-
Levine Cancer CenterCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27705-
Kaiser Permanente NorthwestPortlandOregon97227-
MD Anderson Cancer CenterHoustonTexas77030-
University of WashingtonSeattleWashington98195-

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By research site
University of California Los Angeles (UCLA)· Los Angeles, CAUniversity of Florida Division of Sponsored Programs· Gainesville, FLUniversity of Kentucky, Markey Cancer Center Clinical Research Organization· Lexington, KYNorton Cancer Institute· Louisville, KYStony Brook University· Stony Brook, NYLevine Cancer Center· Charlotte, NC

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