Phase 1 Study of Radioimmunotherapy with 111Indium and 225Actinium-DOTA-Daratumumab Combined with Daratumumab for Adults with Relapsed or Refractory Multiple Myeloma

What this Trial Is About

Researchers are evaluating a combination treatment involving actinium Ac 225-DOTA-daratumumab 225Ac-DOTA-daratumumab, daratumumab, and indium In 111-DOTA-daratumumab 111In-DOTA-daratumumab for patients with multiple myeloma that has returned or does not respond to previous treatments. This phase I trial aims to test the safety, side effects, and best dose of these combined therapies, which use a monoclonal antibody linked to radioactive tracers to target and attack cancer cells. Patients receive daratumumab through an intravenous infusion lasting 45 minutes. Two hours later, they receive both 111In-DOTA-daratumumab and 225Ac-DOTA-daratumumab intravenously over 20 to 30 minutes. The study uses a dose-escalation approach to find the maximum tolerated dose and recommended dose for future studies. After treatment, patients are followed closely with weekly visits for 8 weeks, biweekly visits for 4 weeks, monthly visits for 16 weeks, and then periodic check-ups up to 12 months. During the study, participants will undergo multiple assessments including blood and bone marrow tests, imaging scans to track how the treatment spreads in the body, and evaluations of how well the cancer responds. Researchers will monitor side effects, overall response, survival rates, and how long the treatment controls the disease. The total involvement can last up to a year, with detailed follow-up to ensure safety and measure treatment effects.

Radioimmunotherapy (111Indium/225Actinium-DOTA-daratumumab) for the Treatment of Relapsed/Refractory Multiple Myeloma