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

Status: Recruiting
Location: See all (38) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
University of California San Francisco
RECRUITING
San Francisco
Colorado
Colorado Blood Cancer Institute
RECRUITING
Denver
Connecticut
Yale University School Of Medicine
RECRUITING
New Haven
North Carolina
Duke University Medical Center
RECRUITING
Durham
New York
Icahn School of Medicine at Mt. Sinai
RECRUITING
New York
University of Rochester Medical Center
RECRUITING
Rochester
Ohio
University Hospitals Cleveland Medical Center
RECRUITING
Cleveland
Virginia
Virginia Commonwealth University - Massey Cancer Center
RECRUITING
Richmond
Washington
University of Washington
RECRUITING
Seattle
Other Locations
Brazil
Hospitais Integrados da Gavea SA DF Star
RECRUITING
Brasília
Fundacao Universidade de Caxias do Sul
RECRUITING
Caxias Do Sul
Hospital Erasto Gaertner- Liga Paranaense de Combate ao Cancer
RECRUITING
Curitiba
Instituto D Or de Pesquisa e Ensino
RECRUITING
Salvador
Clinica Medica Sao Germano S/S LTDA
RECRUITING
São Paulo
Instituto D Or de Pesquisa e Ensino IDOR
RECRUITING
São Paulo
Netherlands
VUMC Amsterdam
RECRUITING
Amsterdam
Albert Schweitzer Ziekenhuis
RECRUITING
Dordrecht
Erasmus MC
RECRUITING
Rotterdam
Puerto Rico
Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center
RECRUITING
San Juan
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
The Catholic University of Korea Seoul St Mary s Hospital
RECRUITING
Seoul
Spain
Hosp. Univ. Germans Trias I Pujol
RECRUITING
Badalona
Hosp Clinic de Barcelona
RECRUITING
Barcelona
Hosp. Univ. Virgen de La Arrixaca
RECRUITING
El Palmar
Hosp. de Jerez de La Frontera
RECRUITING
Jerez De La Frontera
Hosp. Univ. 12 de Octubre
RECRUITING
Madrid
Hosp. Univ. Ramon Y Cajal
RECRUITING
Madrid
Hosp. Quiron Madrid Pozuelo
RECRUITING
Pozuelo De Alarcón
Hosp Clinico Univ de Salamanca
RECRUITING
Salamanca
United Kingdom
Belfast City Hospital
RECRUITING
Belfast
Colchester Hospital University NHS
RECRUITING
Colchester
Eastbourne District General Hospital
RECRUITING
Eastbourne
The Clatterbridge Cancer Centre
RECRUITING
Liverpool
Hammersmith Hospital
RECRUITING
London
University College London Hospitals
RECRUITING
London
The Christie NHS Foundation Trust Christie Hospital
RECRUITING
Manchester
Newcastle Freeman Hospital
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Study Contact
Participate-In-This-Study1@its.jnj.com
844-434-4210
Time Frame
Start Date: 2024-08-26
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 210
Treatments
Active_comparator: Cohort A: Talquetamab
Participants with relapsed or refractory multiple myeloma (RRMM) who are triple-class exposed (previously exposed to at least 1 proteasome inhibitor \[PI\], 1 immunomodulatory drug(s) \[IMiD\]), and an anti-CD38 monoclonal antibody \[mAb\]) will be treated with talquetamab subcutaneously until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first.
Experimental: Cohort B: Prophylaxis A and Talquetamab
Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis A along with talquetamab therapy. Participants will start the assigned prophylaxis 7 days before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from Cycle 1 Day 1 (C1D1) until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first.
Experimental: Cohort C: Prophylaxis B and Talquetamab
Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis B along with talquetamab therapy. Participants will start the assigned prophylaxis 7 days before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first.
Experimental: Cohort D: Prophylaxis C and Talquetamab
Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis C along with talquetamab therapy. Participants will start the assigned prophylaxis 7 days before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first.
Experimental: Cohort E: Prophylaxis D and Talquetamab
Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive prophylaxis D along with talquetamab therapy. Participants will start the assigned prophylaxis 1 day before starting talquetamab treatment. After step-up dosing of talquetamab therapy, participants will be treated with talquetamab with prophylaxes for up to 12 months during prophylaxis treatment phase (if there are clinical benefits prophylaxis treatment can continue beyond 12 months, at the treating physician's discretion, after consultation with sponsor). The Talquetamab treatment phase will continue from C1D1 until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of talquetamab, or end of study, whichever occurs first.
Experimental: Cohort F: Ramantamig
Participants with RRMM who are triple-class exposed (previously exposed to at least 1 PI, 1 IMiD, and an anti-CD38 mAb) will receive single step-up dose of ramantamig subcutaneously followed by the treatment dose until disease progression, death, unacceptable toxicity, withdrawal of consent, discontinuation of ramantamig, or end of study, whichever occurs first.
Related Therapeutic Areas
Sponsors
Leads: Janssen Research & Development, LLC

This content was sourced from clinicaltrials.gov

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