Linvoseltamab alone or with carfilzomib versus standard combination regimens for adults with relapsed/refractory multiple myeloma.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional trial compares linvoseltamab given as monotherapy or in combination with carfilzomib against several standard-of-care combination regimens in adults with relapsed/refractory multiple myeloma. Eligible participants must have had 1–3 prior lines of therapy that included lenalidomide and either a proteasome inhibitor or an anti‑CD38 antibody and must have documented progressive disease with ECOG performance status 0–2. The study measures depth and duration of response, safety and side effects, pharmacokinetics of linvoseltamab, and development of anti-drug antibodies. Patients with prior T cell–based BCMA-directed therapies are excluded.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Participant with RRMM who received at least 1 but not more than 3 prior lines of therapy, which must have included treatment with lenalidomide and either a Protease Inhibitor (PI) or anti-CD38 monoclonal antibody
2. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2
3. Confirmed progressive disease according to IMWG criteria during or after the most recent line of therapy

Key Exclusion Criteria:

1. Prior treatment with a T cell-based immunotherapy targeting BCMA, including BCMA-directed bispecific antibodies, Bispecific T-cell Engagers (BiTEs), and Chimeric Antigen Receptor (CAR) T cells. Antibody-drug conjugates targeting BCMA (eg, belantamab mafodotin) are not excluded
2. Diagnosis of plasma cell leukemia, symptomatic amyloidosis (including myeloma-associated amyloidosis), Waldenström macroglobulinemia (lymphoplasmacytic lymphoma), or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
3. Known Central Nervous System (CNS) involvement of myeloma including meningeal involvement
4. History of neurodegenerative condition, Progressive Multifocal Leukoencephalopathy (PML), or CNS movement disorder

NOTE: Other protocol defined inclusion/exclusion criteria apply

Where it's running

• Emory Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• Memorial Sloan Kettering Cancer Center
  New York, New York, United States Recruiting
• Stony Brook University Hospital
  Stony Brook, New York, United States Recruiting
• OhioHealth
  Columbus, Ohio, United States Recruiting
• Baylor University Medical Center
  Dallas, Texas, United States Recruiting
• University of Texas Health Science Center, Houston
  Houston, Texas, United States Recruiting

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Linvoseltamab with pre-dose Tocilizumab to reduce CRS in adults with relapsed/refractory multiple myeloma

  This study tests whether giving tocilizumab before the first dose of linvoseltamab can lower the risk of cytokine release syndrome in adults with relapsed/refractory multiple myeloma who have had at least four prior therapies.

  Recruiting at 7 sites Phase 4 Regeneron Pharmaceuticals · Los Angeles, California and 6 other locations · NCT07609940

• REGN17372 plus linvoseltamab tolerability for adults with relapsed/refractory multiple myeloma

  This trial tests whether giving REGN17372 together with linvoseltamab is safe and what dose works for adults whose multiple myeloma has come back or stopped responding.

  Recruiting at 9 sites Phase 1/2 Regeneron Pharmaceuticals · Liverpool, New South Wales and 8 other locations · NCT07455851

• Linvoseltamab vs. Daratumumab in high-risk smoldering myeloma

  This study tests whether linvoseltamab can delay progression to active myeloma better than daratumumab in people with high-risk smoldering multiple myeloma.

  Recruiting at 33 sites Phase 3 Regeneron Pharmaceuticals · Phoenix, Arizona and 32 other locations · NCT07393282

• Response-based lowering of linvoseltamab doses for relapsed or refractory multiple myeloma

  This trial tests whether lowering linvoseltamab doses for people with relapsed or refractory multiple myeloma can control the cancer while reducing side effects.

  Recruiting Phase 1/2 Fred Hutchinson Cancer Center · Seattle, Washington · NCT07181941

• Linvoseltamab versus standard daratumumab‑lenalidomide‑dexamethasone for adults with newly diagnosed, transplant‑ineligible multiple myeloma

  This trial tests whether linvoseltamab works better or is safer than the standard daratumumab‑lenalidomide‑dexamethasone combination in adults newly diagnosed with multiple myeloma who are not eligible for transplant.

  Recruiting at 59 sites Phase 3 European Myeloma Network B.V. · Adelaide and 58 other locations · NCT06932562

• Add linvoseltamab to lenalidomide maintenance to deepen responses and regain MRD-negative status in newly diagnosed multiple myeloma

  This trial tests whether adding linvoseltamab to lenalidomide maintenance can clear remaining myeloma cells (make you MRD-negative) or help patients who relapsed get back to MRD-negative in newly diagnosed multiple myeloma.

  Recruiting Phase 2 University of Miami · Miami, Florida · NCT06910124

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.