A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events

What this Trial Is About

Researchers are studying preventive treatments to reduce the occurrence, severity, and duration of taste changes dysgeusia caused by talquetamab and ramantamig in patients with relapsed or refractory multiple myeloma RRMM who have been previously treated with certain therapies. The study aims to better understand the signs and symptoms of taste changes related to these treatments. This is a Phase 2, open-label, randomized clinical trial focused on GPRC5D-related oral events. Participants with RRMM who have been exposed to at least one proteasome inhibitor, one immunomodulatory drug, and an anti-CD38 monoclonal antibody will receive talquetamab or ramantamig. Talquetamab is given subcutaneously, and ramantamig is given as a single step-up subcutaneous dose followed by treatment doses. Participants are divided into cohorts receiving talquetamab alone or talquetamab combined with one of four prophylaxis treatments oral or topical, starting before talquetamab treatment. Prophylaxis treatments continue for up to 12 months, with possible extension based on benefit and physician decision. During the study, participants will be closely monitored with taste tests, assessments of oral symptoms, quality of life questionnaires, and tracking of side effects. Researchers will measure the frequency and severity of taste changes, time to onset and resolution, and other oral toxicities over up to 36 months. Safety, response to treatment, and changes in physical health measures such as body weight and BMI will also be evaluated. The study continues until disease progression, unacceptable toxicity, withdrawal, or study end, with ongoing assessments throughout.

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