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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 Participants With Multiple Myeloma That is Resistant to Current Standard of Care Treatments

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

Phase 1RecruitingRegeneron PharmaceuticalsNCT05137054Data as of Sep 2026Location: International · 5 countries

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

Treatments studied

Immunotherapy

LinvoseltamabDaratumumabIsatuximabCemiplimab

Targeted therapy

CarfilzomibBortezomib

Endocrine / hormonal

LenalidomidePomalidomide

Other

FianlimabNirogacestatCevostamab

Cancer type

Multiple Myeloma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: systemic anti-myeloma therapy

RRMM with progression following at least 3 lines of therapy, or at least 2 lines of therapy and either prior exposure to at least 1 anti-CD38 antibody, 1 immunomodulatory imide drug (IMiD) and 1 Proteasome Inhibitor (PI), or double-refractory to 1 PI and 1 IMiD, or the combination of 1 PI and 1 IMiD

Must have received: systemic anti-myeloma therapy

RRMM with progressive disease and received at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 IMiD, and 1 PI or triple-class refractory disease (anti-CD38 antibody, IMiD, PI)

Must have received: systemic anti-myeloma therapy

Progressive RRMM in participants with triple-class refractory disease (anti-CD38 antibody, IMiD, PI) after at least 3 lines of therapy

Must have received: systemic anti-myeloma therapy

Progressive RRMM after at least 3 lines of therapy including exposure to at least 1 anti-CD38 antibody, 1 IMiD, and 1 PI

Cannot have received: allogeneic stem cell transplant

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

Cannot have received: autologous stem cell transplant

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

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

Exception: BCMA antibody-drug conjugates are not excluded

Prior treatment with a T cell-based immunotherapy directed against B-Cell Maturation Antigen (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: BCMA-directed CAR T-cell therapy

Exception: Cohort 2: Dose expansion: Prior treatment with a BCMA-directed CAR T-cell therapy will not be exclusionary if completed at least 12 weeks prior to first study treatment

Cohort 2: Dose expansion: Prior treatment with a BCMA-directed CAR T-cell therapy will not be exclusionary if completed at least 12 weeks prior to first study treatment

Cannot have received: lenalidomide (lenalidomide)

Exception: Known malabsorption syndrome or pre-existing gastrointestinal (GI) condition that may impair absorption of lenalidomide; delivery of lenalidomide via nasogastric tube or gastrostomy tube is not allowed

Cohort 3: Known malabsorption syndrome or pre-existing gastrointestinal (GI) condition that may impair absorption of lenalidomide; delivery of lenalidomide via nasogastric tube or gastrostomy tube is not allowed

Cannot have received: bortezomib (bortezomib)

Exception: Peripheral neuropathy grade ≥2

Cohort 4: Peripheral neuropathy grade ≥2

Cannot have received: pomalidomide (pomalidomide)

Exception: Known malabsorption syndrome or pre-existing GI conditions that may impair absorption of pomalidomide; delivery of pomalidomide via nasogastric tube or gastrostomy tube is not allowed

Cohort 5: Known malabsorption syndrome or pre-existing GI conditions that may impair absorption of pomalidomide; delivery of pomalidomide via nasogastric tube or gastrostomy tube is not allowed

Cannot have received: anti-LAG-3 agent

Cohort 7: Prior treatment with anti-Lymphocyte Activation Gene 3 (LAG-3) agents

Cannot have received: anti-PD-1 agent

Cohort 8: Prior treatment with anti-PD-1 or anti-PD-L1 agents

Cannot have received: anti-PD-L1 agent

Cohort 8: Prior treatment with anti-PD-1 or anti-PD-L1 agents

Cannot have received: solid organ transplant

Cohort 7: Prior solid organ transplant; Cohort 8: Prior solid organ transplant

Cannot have received: cevostamab or FcRH5-targeted agent (cevostamab)

Cohort 10: Prior treatment with cevostamab or another agent with the same target [Fragment crystallizable Receptor-like 5 (FcRH5)]

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 →

Frequently asked questions

Is NCT05137054 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior allogeneic stem cell transplant, autologous stem cell transplant, T cell-based immunotherapy directed against BCMA (bispecific antibodies, BiTEs, BCMA CAR-T cells) disqualifies patients from enrollment.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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