RECRUITINGPhase 2INTERVENTIONAL
A Study to Evaluate Preventive Treatments for GPRC5D-related Oral Events
A Phase 2, Open-label, Randomized Study to Evaluate GPRC5D-related Oral Events
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
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.
Locations (20)
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