Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Linvoseltamab for Relapsed Refractory Multiple Myeloma (RRMM)

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.

Official registry: https://clinicaltrials.gov/study/NCT05730036 · Regeneron Pharmaceuticals · enrollment listed as 410

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Linvoseltamab, Elotuzumab, or Pomalidomide. The registry lists allocation as randomized. This study is researching an experimental drug called linvoseltamab, also called REGN5458.

They plan to enroll about 410 people at 159 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: Linvoseltamab, Elotuzumab, Pomalidomide, Dexamethasone

Primary outcome (registry wording): Progression Free Survival (PFS) per International Myeloma Working Group (IMWG) response criteria determined by Independent Review Committee (IRC) in CD38 antibody exposed participants

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Age 18 years or older (or legal adult age in the country) at the time of the screening visit
  • 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
  • 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
  • Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
  • Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium
  • Life expectancy of at least 6 months

Public study contact (from the registry)

Clinical Trials Administrator

844-734-6643

clinicaltrials@regeneron.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

159 listed

+ 149 sites outside the US on the same record

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FAQ about this NCT record

Is NCT05730036 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05730036?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05730036?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary