Study of Linvoseltamab Dose Reduction for Treating Relapsed or Refractory Multiple Myeloma Evaluating Safety and Effectiveness with Different Dosing Schedules

What this Trial Is About

Researchers are evaluating the safety and feasibility of reducing the dose of linvoseltamab, a bispecific antibody, in treating patients with multiple myeloma that has returned after improvement, does not respond to treatment, or is resistant to three classes of therapies including proteasome inhibitors, immunomodulatory agents, and monoclonal antibodies. This phase III trial aims to find optimal dosing schedules that might lower treatment side effects while maintaining disease control. Participants initially receive linvoseltamab intravenously once a week for 14 weeks, then every two weeks if the disease does not progress or side effects are unacceptable. Disease response is checked starting at week 3 and every 4 weeks thereafter. Patients achieving a very good partial response or better after at least 14 weeks are assigned to one of three groups receiving reduced doses every 4, 8, or 12 weeks. Throughout the trial, patients undergo bone marrow tests, blood sample collection, and may have CT or PETCT scans as needed. After treatment ends, patients are followed for 3 months. During the study, participants will have regular evaluations including bone marrow aspiration and biopsy, blood tests, and imaging scans to monitor disease and safety. Researchers will measure outcomes such as early disease progression within 3 months of dose reduction and residual disease status one year after starting treatment. The trial involves frequent clinic visits for treatment and assessments, with ongoing monitoring to understand the effects of dose adjustments over time.

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