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OncoMatch/Clinical Trials/NCT07181941

Response-Based Dose Reduction of Linvoseltamab in the Treatment of Relapsed, Refractory, or Triple-Class Relapsed/Refractory Multiple Myeloma

Is NCT07181941 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Linvoseltamab for recurrent multiple myeloma.

Phase 1/2RecruitingFred Hutchinson Cancer CenterNCT07181941Data as of May 2026

Treatment: LinvoseltamabThis phase I/II trial evaluates the safety and feasibility of early, response-based dose reduction of linvoseltamab in the treatment of patients multiple myeloma that has come back after a period of improvement (relapsed), that does not respond to treatment (refractory), or that is resistant to three classes of therapeutic agents, including proteasome inhibitors, immunomodulatory agents, and monoclonal antibodies (triple-class relapsed/refractory). Linvoseltamab is a bispecific antibody. Upon administration, linvoseltamab binds to the BCMA protein on cancer cells and the CD3 protein on T cells (a type of immune cell). This generates an immune response that stimulates the T cells to kill the cancer cells. Optimal dosing schedules of linvoseltamab have not yet been determined. Reducing the dosage of linvoseltamab may reduce treatment-related side effects while maintaining long-term disease outcomes.

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Extracted eligibility criteria

Cancer type

Multiple Myeloma

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 4 prior lines

Must have received: proteasome inhibitor

received at least 4 prior lines of therapy including proteasome inhibitor (PI), immunomodulatory imide drug (IMiD), and anti-CD38 monoclonal antibody

Must have received: immunomodulatory imide drug

received at least 4 prior lines of therapy including proteasome inhibitor (PI), immunomodulatory imide drug (IMiD), and anti-CD38 monoclonal antibody

Must have received: anti-CD38 monoclonal antibody

received at least 4 prior lines of therapy including proteasome inhibitor (PI), immunomodulatory imide drug (IMiD), and anti-CD38 monoclonal antibody

Cannot have received: CAR-T cell therapy

Previous treatment with chimeric antigen receptor (CAR) T therapy or any gene therapy products

Cannot have received: gene therapy

Previous treatment with chimeric antigen receptor (CAR) T therapy or any gene therapy products

Lab requirements

Blood counts

Platelet count ≥50 x 10⁹/L (no transfusion ≤7 days); ANC ≥1.0 x 10⁹/L (no G-CSF ≤2 days); Hemoglobin ≥8.0 g/dL

Kidney function

Serum creatinine clearance by Cockcroft-Gault ≥30 mL/min (measured CrCl ≥30 mL/min allowed at PI discretion)

Liver function

Total bilirubin ≤1.5 x ULN (Gilbert syndrome exception); ALT/AST ≤2.5 x ULN; alkaline phosphatase ≤2.5 x ULN

Adequate organ function (based on testing ≤14 days prior to registration): ... see details

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

US trial sites

  • Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington

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