NCT06500884RecruitingPhase 2
A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events
A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- First submitted
- 8 Jul 2024
- Start date
- 26 Aug 2024
- Primary completion date
- 30 May 2030
- Lead sponsor
- Janssen Research & Development, LLC
- Diseases
- Multiple myeloma
- NCT number
- NCT06500884
- EU CT number
- 2023-506260-14-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 210
- From 26 Aug 2024 to the primary completion date, 30 May 2030
- 38 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Contraindications or life-threatening known allergies, hypersensitivity, or intolerance to any study drug or its excipients
Who the study is looking for
- Multiple myeloma (MM) according to IMWG diagnostic criteria
- Were triple-class exposed (received prior treatment with a PI, an IMiD, and anti CD38 mAb)
- Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen
- Have an Eastern Cooperative Oncology Group-performance status (ECOG-PS) of 0 or 1 at screening. Participants with ECOG-PS 2 or 3 are eligible for the study if the ECOG-PS score is related to stable physical limitations (e.g., wheelchair-bound due to prior spinal cord injury) and not related to multiple myeloma or associated therapy
- Be willing and able to adhere to the lifestyle restrictions specified in the protocol
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (38)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IDOR - Regional Brasilia Coordinator of this site? Confirm its status | Brasília | Brazil | Recruiting |
| Fundacao Universidade de Caxias Do Sul Coordinator of this site? Confirm its status | Caxias do Sul | Brazil | Recruiting |
| Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer Coordinator of this site? Confirm its status | Curitiba | Brazil | Recruiting |
| IDOR - Regional Bahia Coordinator of this site? Confirm its status | Salvador | Brazil | Recruiting |
| Clinica Medica Sao Germano LTDA Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| IDOR - Regional Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital de Jerez de la Frontera Coordinator of this site? Confirm its status | Jerez de la Frontera | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Recruiting |
| Hospital Universitario De Salamanca Coordinator of this site? Confirm its status | Salamanca | Spain | Recruiting |
| Belfast City Hospital Coordinator of this site? Confirm its status | Belfast | United Kingdom | Recruiting |
| Colchester Hospital University NHS Coordinator of this site? Confirm its status | Colchester | United Kingdom | Recruiting |
| Eastbourne District General Hospital Coordinator of this site? Confirm its status | Eastbourne | United Kingdom | Recruiting |
| The Clatterbridge Cancer Centre Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Recruiting |
| University College London Hospitals Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Hammersmith Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Christie NHS Foundation Trust - Christie Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| Newcastle Freeman Hospital Coordinator of this site? Confirm its status | Newcastle upon Tyne | United Kingdom | Completed |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Amsterdam UMC Stichting Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Recruiting |
| Albert Schweitzer Ziekenhuis Coordinator of this site? Confirm its status | Dordrecht | Netherlands | Recruiting |
| Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC) Coordinator of this site? Confirm its status | Rotterdam | Netherlands | Recruiting |
| Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Recruiting |
| University Hospitals Cleveland Medical Center* Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
| Colorado Blood Cancer Institute Coordinator of this site? Confirm its status | Denver | United States | Recruiting |
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Yale University School Of Medicine Coordinator of this site? Confirm its status | New Haven | United States | Recruiting |
| Icahn School of Medicine at Mt. Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
| Virginia Commonwealth University/Massey Cancer Center Coordinator of this site? Confirm its status | Richmond | United States | Recruiting |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Recruiting |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Recruiting |
| University of Washington Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.