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RECRUITING

NCT06500884

PHASE2

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

Sponsor: Janssen Research & Development, LLC

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

210

Start Date

2024-08-26

Completion Date

2029-04-30

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Multiple Myeloma

Interventions

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.

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

Locations (38)

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

Hospitais Integrados da Gavea SA DF Star

Brasília, Brazil

Fundacao Universidade de Caxias do Sul

Caxias do Sul, Brazil

Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

Curitiba, Brazil

Instituto D Or de Pesquisa e Ensino

Salvador, Brazil

Clinica Medica Sao Germano S/S LTDA

São Paulo, Brazil

Instituto D Or de Pesquisa e Ensino IDOR

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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (38)