NCT06500884

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

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify preventive treatments that can minimize the occurrence, severity, and duration of talquetamab-related taste changes (dysgeusia), during the prophylaxis (preventive) treatment phase, to better characterize the signs or symptoms of talquetamab-related taste changes and to better characterize the signs or symptoms of ramantamig-related taste changes.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Talquetamab	Talquetamab will be administered subcutaneously.
DRUG	Prophylaxis A	Prophylaxis A will be administered orally.
DRUG	Prophylaxis B	Prophylaxis B will be administered orally.
DRUG	Prophylaxis C	Prophylaxis C will be administered orally.
DRUG	Prophylaxis D	Prophylaxis D will be administered topically.
DRUG	Ramantamig	Ramantamig will be administered subcutaneously.

Timeline

• Start date: 2024-08-26
• Primary completion: 2026-04-15
• Completion: 2029-04-30
• First posted: 2024-07-15
• Last updated: 2026-04-13

Locations

38 sites across 7 countries: United States, Brazil, Netherlands, Puerto Rico, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study