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.
Treatment: Linvoseltamab · Daratumumab · Carfilzomib · Lenalidomide · Bortezomib · Pomalidomide · Isatuximab · Fianlimab · Cemiplimab · Nirogacestat · Cevostamab — This 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Targeted therapy
Endocrine / hormonal
Other
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.
Check if I qualifyRelated pages