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.
RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Linvoseltamab for Multiple Myeloma

This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma. Linvoseltamab has previously been studied as a single agent (without other cancer treatments) in participants with multiple myeloma that returned after prior therapies and needed to be treated again.

Official registry: https://clinicaltrials.gov/study/NCT05137054 · Regeneron Pharmaceuticals · enrollment listed as 317

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

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, Daratumumab, or Carfilzomib. The registry lists allocation as randomized. This study is researching an experimental drug called linvoseltamab in combination with other drugs for the treatment of a blood cancer called multiple myeloma.

They plan to enroll about 317 people at 42 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Phase 1b Study of REGN5458 (Anti-BCMA x Anti-CD3 Bispecific Antibody) Plus Other Cancer Treatments for Patients With Relapsed/Refractory Multiple Myeloma

Interventions: Linvoseltamab, Daratumumab, Carfilzomib, Lenalidomide, Bortezomib, Pomalidomide, Isatuximab, Fianlimab, Cemiplimab, Nirogacestat, Cevostamab

Primary outcome (registry wording): Incidence of Dose Limiting Toxicities (DLTs) for each study regimen during the observation period

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤1
  • Participants must have measurable disease as defined in the protocol according to IMWG consensus criteria
  • Adequate creatinine clearance, hematologic function and hepatic function, as defined in protocol
  • Life expectancy of at least 6 months
  • Cohort Specific who can join:
  • For participants without measurable disease by biochemical parameters \[serum or urine M-protein, or serum involved Free Light Chain (FLC)\], presence of at least 1 soft tissue plasmacytoma with a single diameter of ≥2 cm

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

42 listed

+ 29 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phaseBuffalo, New York
Not a traditional drug phase: testing Beta-Adrenergic Antagonist for Plasma Cell Myeloma

This clinical trial investigates the effect of non-chemotherapeutic interventions in patients with multiple myeloma or MDS. Non-chemotherapeutic interventions such as physical activity and nutritional interventions (e.g., modifications in diet) have been shown to positively affect the immune system and improve overall quality of life.

NCT05312255 · Official ClinicalTrials.gov record · Roswell Park Cancer Institute

FAQ about this NCT record

Is NCT05137054 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 NCT05137054?

Phase 1. 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 NCT05137054?

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