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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Talquetamab
    Talquetamab will be administered subcutaneously.
    Other names:
    • CD3xGPRC5D
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.
  • Drug: Talquetamab
    Talquetamab will be administered subcutaneously.
    Other names:
    • CD3xGPRC5D
  • Drug: Prophylaxis A
    Prophylaxis A will be administered orally.
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.
  • Drug: Talquetamab
    Talquetamab will be administered subcutaneously.
    Other names:
    • CD3xGPRC5D
  • Drug: Prophylaxis B
    Prophylaxis B will be administered orally.
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.
  • Drug: Talquetamab
    Talquetamab will be administered subcutaneously.
    Other names:
    • CD3xGPRC5D
  • Drug: Prophylaxis C
    Prophylaxis C will be administered orally.
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.
  • Drug: Talquetamab
    Talquetamab will be administered subcutaneously.
    Other names:
    • CD3xGPRC5D
  • Drug: Prophylaxis D
    Prophylaxis D will be administered topically.
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.
  • Drug: Ramantamig
    Ramantamig will be administered subcutaneously.
    Other names:
    • BCMAxGPRC5DxCD3

Recruiting Locations

University of California San Francisco
San Francisco, California 94143

Colorado Blood Cancer Institute
Denver, Colorado 80218

Yale University School Of Medicine
New Haven, Connecticut 06510

Icahn School of Medicine at Mt. Sinai
New York, New York 10029

University of Rochester Medical Center
Rochester, New York 14642

Duke University Medical Center
Durham, North Carolina 27705

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

Virginia Commonwealth University - Massey Cancer Center
Richmond, Virginia 23298

University of Washington
Seattle, Washington 98109

Hospital Espanol Auxilio Mutuo Auxilio Mutuo Cancer Center
San Juan, Puerto Rico 00918

More Details

Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.