Study of Linvoseltamab Drug Safety and Effectiveness in Adults With Newly Diagnosed Multiple Myeloma Eligible or Not for Stem Cell Transplant

What this Trial Is About

Researchers are studying an experimental drug called linvoseltamab in adults newly diagnosed with symptomatic multiple myeloma who have not yet received treatment. The study aims to evaluate the safety, tolerability, and effectiveness of linvoseltamab, particularly how it may shrink tumors and work before and after stem cell transplant. This trial includes phases to find the right dosing and to monitor side effects and responses over time. Linvoseltamab is given by intravenous infusion in different dosing schedules. The study has several parts Phase 1 includes dose escalation and evaluation of alternative dosing regimens, while Phase 2 treats transplant-eligible participants for a fixed time and transplant-ineligible participants until disease progression with the selected dosing. The study evaluates linvoseltamab both before and after autologous stem cell transplantation. Participants will be closely monitored through various assessments including tracking side effects, measuring drug levels in the blood, and checking for antibodies against the drug. Response to treatment is measured by tumor shrinkage and minimal residual disease status up to five years. Safety monitoring continues up to 90 days after the last dose, with long-term follow-up for treatment effectiveness and survival. The study duration varies depending on transplant eligibility and treatment response.

A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment