RecruitingPhase 2NCT06500884

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

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

Sponsor

Janssen Research & Development, LLC

Enrollment

210 participants

Start Date

Aug 26, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing treatments to prevent or reduce mouth-related side effects (such as taste changes and mouth sores) caused by a multiple myeloma drug called talquetamab. Patients already receiving talquetamab will be assigned to different preventive strategies. **You may be eligible if...** - You have multiple myeloma - You have already received at least three different classes of myeloma treatments (a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody) - Your myeloma has gotten worse after your most recent treatment - Your overall health is good to moderate (ECOG score 0–1, or 2–3 only if due to a pre-existing stable physical limitation unrelated to myeloma) - You are willing to follow the lifestyle restrictions required by the study **You may NOT be eligible if...** - You have a known allergy to talquetamab or any study drug - You have had a stroke, mini-stroke, or seizure in the past 6 months - You have had a serious heart event in the past 6 months (heart attack, severe heart failure, major blood clot) - You have had major surgery recently - You already have severe mouth or taste problems (severe dysgeusia) at the start of the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTalquetamab

Talquetamab will be administered subcutaneously.

DRUGProphylaxis A

Prophylaxis A will be administered orally.

DRUGProphylaxis B

Prophylaxis B will be administered orally.

DRUGProphylaxis C

Prophylaxis C will be administered orally.

DRUGProphylaxis D

Prophylaxis D will be administered topically.

DRUGRamantamig

Ramantamig will be administered subcutaneously.

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

View Full Details on ClinicalTrials.gov

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