Linvoseltamab alone or with carfilzomib versus standard combination regimens for adults with relapsed/refractory multiple myeloma.
An Open-Label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab Plus Carfilzomib Versus Standard of Care Combination Regimens in Patients With Relapsed/Refractory Multiple Myeloma
This trial tests whether linvoseltamab alone or together with carfilzomib works better than standard combination treatments for adults with relapsed or refractory multiple myeloma who have had 1–3 prior therapies.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 915 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Drugs / interventions | belantamab, Chimeric Antigen Receptor, immunotherapy, linvoseltamab |
| Locations | 16 sites (New York, New York and 15 other locations) |
| Trial ID | NCT07222761 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with relapsed or refractory multiple myeloma who have received 1–3 prior therapies (including lenalidomide and either a proteasome inhibitor or an anti‑CD38 antibody), have progressive disease, and have ECOG performance status of 0–2 are the intended participants.
Not a fit: Patients who previously received BCMA‑targeted T cell therapies (BCMA bispecifics, BiTEs, or CAR‑T) or who have plasma cell leukemia, symptomatic amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome are not likely to be eligible or to benefit from this study.
Why it matters
Potential benefit: If successful, the linvoseltamab regimens could produce deeper and longer responses and potentially extend survival compared with current standard regimens.
How similar studies have performed: Other BCMA‑targeting bispecific antibodies and CAR‑T cell therapies have shown promising activity in relapsed/refractory myeloma, though the specific linvoseltamab plus carfilzomib combination is being tested here.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New York, New York and 15 other locations
- Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
- OhioHealth — Columbus, Ohio, United States (Recruiting)
- Mater Misericordiae Ltd — Brisbane, Queensland, Australia (Recruiting)
- Gold Coast Hospital and Health Service — Southport, Queensland, Australia (Recruiting)
- Chonnam National University Hwasun Hospital — Hwasun, Jeollanam-do, South Korea (Recruiting)
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
- Severance Hospital; Division of Hematology — Seoul, South Korea (Recruiting)
- Samsung Medical Center — Seoul, South Korea (Recruiting)
- Seoul St. Mary's Hospital, The Catholic University of Korea — Seoul, South Korea (Recruiting)
- Ulsan University Hospital — Ulsan, South Korea (Recruiting)
- Aberdeen Royal Infirmary — Aberdeen, Aberdeenshire, United Kingdom (Recruiting)
- Royal Cornwall Hospital National Health Service (NHS) Foundation Trust — Truro, Cornwall, United Kingdom (Recruiting)
- University Hospitals Plymouth National Health Service (NHS) Foundation Trust - Hematology — Plymouth, Devon, United Kingdom (Recruiting)
- Norfolk and Norwich University Hospital National Health Service (NHS) Foundation Trust — Norwich, Norfolk, United Kingdom (Recruiting)
- University Hospitals Birmingham NHS Trust, Center for Clinical — Birmingham, West Midlands, United Kingdom (Recruiting)
- Ninewells Hospital and Medical School — Dundee, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.