Phase 2 Trial Evaluating Preventive Treatments for Oral Side Effects in Multiple Myeloma Patients Receiving Talquetamab or Ramantamig

What this Trial Is About

This trial focuses on people with relapsed or refractory multiple myeloma who have previously received specific treatments including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies. It aims to study preventive treatments to reduce the occurrence, severity, and duration of taste changes caused by talquetamab, and to better understand the symptoms related to both talquetamab and ramantamig therapies. The study is a Phase 2 trial designed to improve management of oral side effects during treatment. Participants receive talquetamab or ramantamig drugs administered subcutaneously. Some groups receive talquetamab alone, while others receive talquetamab combined with different preventive treatments prophylaxes A, B, C, or D starting before talquetamab therapy. Prophylaxes A, B, and C are given orally, while prophylaxis D is applied topically. Treatment continues until disease progression, unacceptable side effects, withdrawal, or end of study, with prophylaxis lasting up to 12 months but possibly longer based on clinical benefit and doctor decision. During the study, participants will undergo various assessments including taste tests and questionnaires about oral symptoms, quality of life, and body measurements. Researchers will monitor the occurrence and severity of taste changes and other oral toxicities over time, dose adjustments, treatment responses, and safety events. This comprehensive monitoring may last up to 36 months, helping to better characterize the side effects and treatment outcomes for multiple myeloma patients receiving these therapies.

A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events