REGN17372 plus linvoseltamab tolerability 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 1/2, first-in-human study of REGN17372 gives the experimental agent together with linvoseltamab or linvoseltamab alone to adults with relapsed or refractory multiple myeloma who have had at least three prior lines of therapy. Phase 1 focuses on safety and finding the best dose of REGN17372 when combined with linvoseltamab, while Phase 2 evaluates tolerability and clinical activity. The trial will monitor side effects, drug levels in the blood, and whether the body makes antibodies against the drugs, and will measure tumor responses using standard myeloma criteria. Eligible participants must have measurable disease, ECOG ≤1, and adequate organ function and will be treated at participating hospitals in New South Wales, Australia.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Participants with RRMM who have exhausted (or are not a candidate for) all therapeutic options that are expected to provide meaningful clinical benefit and have received at least 3 lines of therapy as defined in the protocol
2. ECOG performance status score ≤1
3. Participants must have measurable disease for response assessment as described in the protocol
4. Adequate hematologic, cardiac, hepatic, and renal function, as described in the protocol

Key Exclusion Criteria:

1. Participants with non-secretory MM, active plasma cell leukemia, known amyloidosis, Waldenström macroglobulinemia, or known POEMS syndrome as defined in the protocol
2. Participants who have known MM brain lesions or CNS involvement
3. Participants with a history of PML, a neurocognitive condition or CNS movement disorder, or a history of seizure within 12 months prior to entering screening
4. Prior treatment with GPRC5D-directed immunotherapies (phase 1 and phase 2) and/or prior treatment with a BCMAxCD3 bispecific antibody (phase 2)

Note: Other protocol defined inclusion/exclusion criteria apply

Where it's running

• South Western Sydney Local Health District - Liverpool Hosptial
  Liverpool, New South Wales, Australia Recruiting
• Prince of Wales Hospital
  Randwick, New South Wales, Australia Recruiting
• Illawarra Cancer care centre, Wollongong Hospital
  Wollongong, New South Wales, Australia Recruiting
• Royal Adelaide Hospital
  Adelaide, South Australia, Australia Recruiting
• St Vincents Hospital Melbourne
  Fitzroy, Victoria, Australia Recruiting
• Peter MacCallum Cancer Centre
  Melbourne, Victoria, Australia Recruiting

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.

• Comparing linvoseltamab to a combination of three other cancer drugs for relapsed/refractory multiple myeloma

  This study is testing if a new drug called linvoseltamab works better than a standard combination of three other cancer drugs for adults with relapsed or refractory multiple myeloma.

  Recruiting at 19 sites Phase 3 Regeneron Pharmaceuticals · Los Angeles, California and 158 other locations · NCT05730036

• 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.