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

This 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

Trial Details

NCT ID
NCT07181941
Phase
PHASE1 / PHASE2
Sponsor
Fred Hutchinson Cancer Center
Status
RECRUITING
Cancer Type
Relapsed/Refractory Multiple Myeloma
Interventions
  • Linvoseltamab
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Computed Tomography
  • Positron Emission Tomography
  • Biospecimen Collection
Locations (sample)
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • Age ≥ 18 years. Myeloma is not seen in the younger age group and safety of B-cell maturation antigen (BCMA) T-cell engagers (TCE) in this group is …
  • Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed co…
  • Confirmed diagnosis of active multiple myeloma (MM) by International Myeloma Working Group (IMWG) diagnostic criteria
  • Patients must have myeloma that is measurable and response evaluable according to 2016 IMWG response criteria. Measurable disease is defined as one…

For full eligibility, visit ClinicalTrials.gov.

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