A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events
A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events
- Multiple Myeloma
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- Janssen Research & Development, LLC
- Enrolment target
- 210
- Started
- 26 August 2024
- Main results due
- 30 May 2030
- Study sites
- 38
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * 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 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(38)
University of California San Francisco
San Francisco, California, United States
Recruiting
Colorado Blood Cancer Institute
Denver, Colorado, United States
Recruiting
Yale University School Of Medicine
New Haven, Connecticut, United States
Recruiting
Icahn School of Medicine at Mt. Sinai
New York, New York, United States
Recruiting
University of Rochester Medical Center
Rochester, New York, United States
Recruiting
Duke University Medical Center
Durham, North Carolina, United States
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Recruiting
Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia, United States
Recruiting
University of Washington
Seattle, Washington, United States
Recruiting
IDOR - Regional Brasilia
Brasília, Brazil
Recruiting
Fundacao Universidade de Caxias do Sul
Caxias do Sul, Brazil
Recruiting
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
Curitiba, Brazil
Recruiting
IDOR - Regional Bahia
Salvador, Brazil
Recruiting
IDOR - Regional Sao Paulo
São Paulo, Brazil
Recruiting
Clinica Medica Sao Germano LTDA
São Paulo, Brazil
Recruiting
VUMC Amsterdam
Amsterdam, Netherlands
Recruiting
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands
Recruiting
Erasmus MC
Rotterdam, Netherlands
Recruiting
Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center
San Juan, Puerto Rico
Recruiting
Seoul National University Hospital
Seoul, South Korea
Recruiting
The Catholic University of Korea Seoul St Mary s Hospital
Seoul, South Korea
Recruiting
Samsung Medical Center
Seoul, South Korea
Recruiting
Hosp. Univ. Germans Trias I Pujol
Badalona, Spain
Recruiting
Hosp Clinic de Barcelona
Barcelona, Spain
Recruiting
Hosp. Univ. Virgen de La Arrixaca
El Palmar, Spain
Recruiting
Hosp. de Jerez de La Frontera
Jerez de la Frontera, Spain
Recruiting
Hosp. Univ. Ramon Y Cajal
Madrid, Spain
Recruiting
Hosp. Univ. 12 de Octubre
Madrid, Spain
Recruiting
Hosp. Quiron Madrid Pozuelo
Pozuelo de Alarcón, Spain
Recruiting
Hosp Clinico Univ de Salamanca
Salamanca, Spain
Recruiting
Belfast City Hospital
Belfast, United Kingdom
Recruiting
Colchester Hospital University NHS
Colchester, United Kingdom
Recruiting
Eastbourne District General Hospital
Eastbourne, United Kingdom
Recruiting
The Clatterbridge Cancer Centre
Liverpool, United Kingdom
Recruiting
University College London Hospitals
London, United Kingdom
Recruiting
Hammersmith Hospital
London, United Kingdom
Recruiting
The Christie NHS Foundation Trust Christie Hospital
Manchester, United Kingdom
Recruiting
Newcastle Freeman Hospital
Newcastle upon Tyne, United Kingdom
Completed
Showing 38 of 38 sites. 37 of the 38 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06500884. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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