RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Janssen Research & Development, LLC • ClinicalTrials.gov ID: NCT06500884

Registry updated: 2026-09-25

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Description

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.

Interventions

Talquetamab (Drug)
Talquetamab will be administered subcutaneously.
Prophylaxis A (Drug)
Prophylaxis A will be administered orally.
Prophylaxis B (Drug)
Prophylaxis B will be administered orally.
Prophylaxis C (Drug)
Prophylaxis C will be administered orally.
Prophylaxis D (Drug)
Prophylaxis D will be administered topically.
Ramantamig (Drug)
Ramantamig will be administered subcutaneously.

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

Conditions

Multiple Myeloma

Locations

University of California San Francisco — San Francisco, California, United States
Colorado Blood Cancer Institute — Denver, Colorado, United States
Yale University School Of Medicine — New Haven, Connecticut, United States
Icahn School of Medicine at Mt. Sinai — New York, New York, United States
University of Rochester Medical Center — Rochester, New York, United States
Duke University Medical Center — Durham, North Carolina, United States
University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
Virginia Commonwealth University - Massey Cancer Center — Richmond, Virginia, United States
University of Washington — Seattle, Washington, United States
IDOR - Regional Brasilia — Brasília, Brazil
Fundacao Universidade de Caxias do Sul — Caxias do Sul, Brazil
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer — Curitiba, Brazil
IDOR - Regional Bahia — Salvador, Brazil
IDOR - Regional Sao Paulo — São Paulo, Brazil
Clinica Medica Sao Germano LTDA — São Paulo, Brazil
VUMC Amsterdam — Amsterdam, Netherlands
Albert Schweitzer Ziekenhuis — Dordrecht, Netherlands
Erasmus MC — Rotterdam, Netherlands
Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center — San Juan, Puerto Rico
Seoul National University Hospital — Seoul, South Korea
The Catholic University of Korea Seoul St Mary s Hospital — Seoul, South Korea
Samsung Medical Center — Seoul, South Korea
Hosp. Univ. Germans Trias I Pujol — Badalona, Spain
Hosp Clinic de Barcelona — Barcelona, Spain
Hosp. Univ. Virgen de La Arrixaca — El Palmar, Spain
Hosp. de Jerez de La Frontera — Jerez de la Frontera, Spain
Hosp. Univ. Ramon Y Cajal — Madrid, Spain
Hosp. Univ. 12 de Octubre — Madrid, Spain
Hosp. Quiron Madrid Pozuelo — Pozuelo de Alarcón, Spain
Hosp Clinico Univ de Salamanca — Salamanca, Spain
Belfast City Hospital — Belfast, United Kingdom
Colchester Hospital University NHS — Colchester, United Kingdom
Eastbourne District General Hospital — Eastbourne, United Kingdom
The Clatterbridge Cancer Centre — Liverpool, United Kingdom
University College London Hospitals — London, United Kingdom
Hammersmith Hospital — London, United Kingdom
The Christie NHS Foundation Trust Christie Hospital — Manchester, United Kingdom
Newcastle Freeman Hospital — Newcastle upon Tyne, United Kingdom

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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