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OncoMatch/Clinical Trials/NCT05137054

A Study to Examine the Effects of Novel Therapy Linvoseltamab in Combination With Other Cancer Treatments for Adult Patients With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

Is NCT05137054 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for multiple myeloma.

Phase 1RecruitingRegeneron PharmaceuticalsNCT05137054Data as of May 2026

Treatment: Linvoseltamab · Daratumumab · Carfilzomib · Lenalidomide · Bortezomib · Pomalidomide · Isatuximab · Fianlimab · Cemiplimab · Nirogacestat · CevostamabThis 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. In the initial study, some participants treated with linvoseltamab had improvement of their myeloma, including complete responses (no evidence of myeloma in their bodies). This study is the first time linvoseltamab will be combined with other cancer therapies. The main goal is to understand if linvoseltamab can be given safely with other cancer treatments, and if so, what dose of linvoseltamab should be used for each combination. The study is looking at several other research questions, including: * How many participants treated with linvoseltamab in combination with each of the other cancer treatments have improvement of their multiple myeloma * What side effects may happen from taking linvoseltamab together with another cancer treatment * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug(s) (which could make the study drug(s) less effective or could lead to side effects)

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 2 prior lines

Must have received: anti-CD38 antibody

prior exposure to at least 1 anti-CD38 antibody

Must have received: immunomodulatory imide drug (IMiD)

prior exposure to at least 1 immunomodulatory imide drug (IMiD)

Must have received: proteasome inhibitor

prior exposure to at least 1 proteasome inhibitor (PI)

Cannot have received: T cell-based immunotherapy directed against BCMA bispecific antibodies and bispecific T-cell engagers (BiTEs), and BCMA chimeric antigen receptor (CAR) T cells

Exception: BCMA antibody-drug conjugates are not excluded

prior treatment with a T cell-based immunotherapy directed against BCMA bispecific antibodies and bispecific T-cell engagers (BiTEs), and BCMA chimeric antigen receptor (CAR) T cells (Note: BCMA antibody-drug conjugates are not excluded)

Cannot have received: systemic anti-myeloma therapy

Treatment with any systemic anti-myeloma therapy within 5 half-lives or within 21 days prior to first administration of study drug regimen, whichever is shorter

Cannot have received: allogeneic and autologous stem cell transplantation

History of allogeneic and autologous stem cell transplantation, as described in the protocol

Lab requirements

Blood counts

adequate hematologic function, as defined in protocol

Kidney function

adequate creatinine clearance, as defined in protocol

Liver function

adequate hepatic function, as defined in protocol

Cardiac function

Cardiac ejection fraction <40% by echocardiogram (Echo) or multigated acquisition (MUGA) scan excluded

Adequate creatinine clearance, hematologic function and hepatic function, as defined in protocol; Cardiac ejection fraction <40% by echocardiogram (Echo) or multigated acquisition (MUGA) scan excluded

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Scripps Clinic Torrey Pines · La Jolla, California
  • Winship Cancer Institute of Emory University · Atlanta, Georgia
  • Indiana University Health Simon Cancer Center · Indianapolis, Indiana
  • Dana Farber/Harvard Cancer Center · Boston, Massachusetts
  • Karmanos Cancer Institute · Detroit, Michigan

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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