Comparing linvoseltamab to a combination of three other cancer drugs for 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 clinical trial is investigating the effectiveness and safety of linvoseltamab, an experimental drug, in comparison to a combination of elotuzumab, pomalidomide, and dexamethasone for adults with relapsed or refractory multiple myeloma. Participants must have previously undergone one to four lines of treatment and show disease progression. The study aims to determine if linvoseltamab can provide better outcomes than the standard combination therapy. The trial will assess tumor shrinkage and overall response rates among participants.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Age 18 years or older (or legal adult age in the country) at the time of the screening visit.
2. 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.
3. Received at least 1 and no more than 4 prior lines of anti-neoplastic MM therapies, including lenalidomide and a proteasome inhibitor and demonstrated disease progression on or after the last therapy as defined by the 2016 IMWG criteria. Participants who have received only 1 line of prior line of antimyeloma therapy must be lenalidomide refractory, as described in the protocol.

   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.
4. Patients must have measurable disease for response assessment as per the 2016 IMWG response assessment criteria, as described in the protocol
5. Adequate hematologic function and hepatic function within 7 days of randomization, as well as adequate renal and cardiac function and corrected calcium
6. Life expectancy of at least 6 months

Key Exclusion Criteria:

1. Diagnosis of plasma cell leukemia, amyloidosis, Waldenström macroglobulinemia, or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes).
2. Prior treatment with elotuzumab and/or pomalidomide
3. Participants with known MM brain lesions or meningeal involvement
4. Treatment with any systemic anti-cancer therapy within 5 half-lives or within 28 days before first administration of study drug, whichever is shorter
5. History of allogeneic stem cell transplantation within 6 months, or autologous stem cell transplantation within 12 weeks of the start of study treatment. Participants who have received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease. Steroids at doses equivalent to suppletion doses may be acceptable.
6. Prior treatment with B-cell maturation antigen (BCMA) directed immunotherapies Note: BCMA antibody-drug conjugates are allowed.
7. History of progressive multifocal leukoencephalopathy (PML), known or suspected PML, or history of a neurocognitive condition or central nervous system (CNS) movement disorder (Parkinson's disease or Parkinsonism).
8. Any infection requiring hospitalization or treatment with IV anti-infectives within 2 weeks of first administration of study drug
9. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV); or another uncontrolled infection, as defined in the protocol 10 Cardiac ejection fraction \<40%.

NOTE: Other protocol defined inclusion/exclusion criteria apply

Where it's running

• Aichi Medial University Hospital
  Nagakute, Aichi-ken, Japan Recruiting
• Chiba Cancer Center
  Chiba, Chiba, Japan Recruiting
• Kameda General Hospital
  Kamogawa, Chiba, Japan Recruiting
• National Cancer Center Hospital East
  Kashiwa-shi, Chiba, Japan Recruiting
• Kurume University Hospital
  Kurume, Fukuoka, Japan Recruiting
• Ogaki Municipal Hospital
  Ōgaki, Gifu, Japan Recruiting

+109 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.

• 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 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

• 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

• Low-dose radiation to boost elranatamab for relapsed/refractory multiple myeloma with extramedullary or paramedullary disease

  We will test whether low-dose radiation given before elranatamab helps people with relapsed or refractory multiple myeloma that has grown outside the bone or into surrounding tissue respond better to treatment.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT07382739

• Linvoseltamab alone or with carfilzomib versus standard combination regimens for adults 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.

  Recruiting at 53 sites Phase 3 Regeneron Pharmaceuticals · Atlanta, Georgia and 52 other locations · NCT07222761

• 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

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.