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NCT06500884PHASE2Recruiting

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

Janssen Research & Development, LLC

Start Date

8/26/2024

Completion Date

5/30/2030

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DRUG

Talquetamab

DRUG

Prophylaxis A

DRUG

Prophylaxis B

DRUG

Prophylaxis C

DRUG

Prophylaxis D

DRUG

Ramantamig

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Conditions

Multiple Myeloma

Locations

University of California San Francisco

San Francisco, California 94143

United States

Colorado Blood Cancer Institute

Denver, Colorado 80218

United States

Yale University School Of Medicine

New Haven, Connecticut 06510

United States

Icahn School of Medicine at Mt. Sinai

New York, New York 10029

United States

University of Rochester Medical Center

Rochester, New York 14642

United States

Duke University Medical Center

Durham, North Carolina 27705

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio 44106

United States

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia 23298

United States

University of Washington

Seattle, Washington 98109

United States

Hospitais Integrados da Gavea SA DF Star

Brasília, 70390-140

Brazil

Fundacao Universidade de Caxias do Sul

Caxias do Sul, 95070 560

Brazil

Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer

Curitiba, 81520-060

Brazil

Instituto D Or de Pesquisa e Ensino

Salvador, 41253 190

Brazil

Clinica Medica Sao Germano S/S LTDA

São Paulo, 01455 010

Brazil

Instituto D Or de Pesquisa e Ensino IDOR

São Paulo, 04543-000

Brazil

VUMC Amsterdam

Amsterdam, 1081 HV

Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, 3318 AT

Netherlands

Erasmus MC

Rotterdam, 3015 CN

Netherlands

Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center

San Juan, 00918

Puerto Rico

Seoul National University Hospital

Seoul, 03080

South Korea

The Catholic University of Korea Seoul St Mary s Hospital

Seoul, 06591

South Korea

Samsung Medical Center

Seoul, 135-230

South Korea

Hosp. Univ. Germans Trias I Pujol

Badalona, 08916

Spain

Hosp Clinic de Barcelona

Barcelona, 08036

Spain

Hosp. Univ. Virgen de La Arrixaca

El Palmar, 30120

Spain

Hosp. de Jerez de La Frontera

Jerez de la Frontera, 11407

Spain

Hosp. Univ. Ramon Y Cajal

Madrid, 28034

Spain

Hosp. Univ. 12 de Octubre

Madrid, 28041

Spain

Hosp. Quiron Madrid Pozuelo

Pozuelo de Alarcón, 28223

Spain

Hosp Clinico Univ de Salamanca

Salamanca, 37007

Spain

Belfast City Hospital

Belfast, BT9 7AB

United Kingdom

Colchester Hospital University NHS

Colchester, CO4 5JL

United Kingdom

Eastbourne District General Hospital

Eastbourne, BN21 2UD

United Kingdom

The Clatterbridge Cancer Centre

Liverpool, L7 8YA

United Kingdom

University College London Hospitals

London, NW1 2BU

United Kingdom

Hammersmith Hospital

London, W12 0HS

United Kingdom

The Christie NHS Foundation Trust Christie Hospital

Manchester, M20 4BX

United Kingdom

Newcastle Freeman Hospital

Newcastle upon Tyne, NE7 7DN

United Kingdom