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

Part of paid clinical trials in San Francisco, California.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT06500884
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Talquetamab — DRUG
    Talquetamab will be administered subcutaneously.
  • Prophylaxis A — DRUG
    Prophylaxis A will be administered orally.
  • Prophylaxis B — DRUG
    Prophylaxis B will be administered orally.
  • Prophylaxis C — DRUG
    Prophylaxis C will be administered orally.
  • Prophylaxis D — DRUG
    Prophylaxis D will be administered topically.
  • Ramantamig — DRUG
    Ramantamig will be administered subcutaneously.

Study Details

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.

Key Dates

Start date
Aug 26, 2024
Status verified
Jun 2026
Primary completion
May 30, 2030
Completion
May 30, 2030

Study Design

Enrollment
210 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Percentage of Participants With Occurrence of Dysgeusia as Assessed by the Total Waterless Empirical Taste Test (WETT) Testing Score During the Prophylaxis Treatment Phase [ Time Frame: Up to 12 months ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143-
Colorado Blood Cancer InstituteDenverColorado80218-
Yale University School Of MedicineNew HavenConnecticut06510-
Icahn School of Medicine at Mt. SinaiNew YorkNew York10029-
University of Rochester Medical CenterRochesterNew York14642-
Duke University Medical CenterDurhamNorth Carolina27705-
University Hospitals Cleveland Medical CenterClevelandOhio44106-
Virginia Commonwealth University - Massey Cancer CenterRichmondVirginia23298-
University of WashingtonSeattleWashington98109-

Find similar trials in San Francisco, CA

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of California San Francisco· San Francisco, CAColorado Blood Cancer Institute· Denver, COYale University School Of Medicine· New Haven, CTIcahn School of Medicine at Mt. Sinai· New York, NYUniversity of Rochester Medical Center· Rochester, NYDuke University Medical Center· Durham, NC

Related Studies