A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events (NCT06500884)
A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (5 items) and avoid the listed exclusions (6 items).
Location: University of California San Francisco — San Francisco, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients
- Stroke, transient ischemic attack, or seizure within 6 months prior to screening
- Any of the following within 6 months prior to the first dose of study treatment: severe or unstable angina, myocardial infarction; major thromboembolytic event (e.g., pulmonary embolism, cerebrovascular accident), clinically significant ventricular arrythmia or heart failure New York Heart Association functional classification Class III or IV. Uncomplicated deep vein thrombosis is not considered exclusionary
- Major surgery or had significant traumatic injury within 2 weeks prior to the start of administration of study treatment, or will not have fully recovered from surgery, or has major surgery planned during the time the participant is expected to be treated in the study or within 2 weeks after administration of the last dose of study treatment
- A WETT score indicating severe dysgeusia at screening and confirmed prior to randomization. Also unresolved/severe dysgeusia referred by the participant or a finding in the physical examination/oral cavity inspection. Some examples include leukoplakia, prior mouth cancers, extensive dental caries, severe periodontitis, active oral infections, candidiasis, parotic gland removal, or radiotherapy with resultant xerostomia
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (38 Sites)
Showing the first 25 of 38 sites.
- University of California San Francisco — San Francisco, California
- Colorado Blood Cancer Institute — Denver, Colorado
- Yale University School Of Medicine — New Haven, Connecticut
- Icahn School of Medicine at Mt. Sinai — New York, New York
- University of Rochester Medical Center — Rochester, New York
- Duke University Medical Center — Durham, North Carolina
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Virginia Commonwealth University - Massey Cancer Center — Richmond, Virginia
- University of Washington — Seattle, Washington
- IDOR - Regional Brasilia — Brasília,
- Fundacao Universidade de Caxias do Sul — Caxias do Sul,
- Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer — Curitiba,
- IDOR - Regional Bahia — Salvador,
- IDOR - Regional Sao Paulo — São Paulo,
- Clinica Medica Sao Germano LTDA — São Paulo,
- VUMC Amsterdam — Amsterdam,
- Albert Schweitzer Ziekenhuis — Dordrecht,
- Erasmus MC — Rotterdam,
- Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center — San Juan,
- Seoul National University Hospital — Seoul,
- The Catholic University of Korea Seoul St Mary s Hospital — Seoul,
- Samsung Medical Center — Seoul,
- Hosp. Univ. Germans Trias I Pujol — Badalona,
- Hosp Clinic de Barcelona — Barcelona,
- Hosp. Univ. Virgen de La Arrixaca — El Palmar,
📞 Contact the Study Coordinator
Phone: (844) 434-4210
Email: Participate-In-This-Study1@its.jnj.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.