A Phase 2, Open-label, Randomized Study to Evaluate Prophylactic Interventions on Talquetamab-related Oral Toxicity TALISMAN
Verified

What's the purpose of this trial?

The purpose of this study is to identify preventive treatments that can minimize the occurrence, severity, and duration of talquetamab-related taste dysfunction (hypogeusia), during the study treatment phase, and to better characterize the signs or symptoms of talquetamab-related taste dysfunction.

This trial has temporarily put patient recruitment on hold.


What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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 enrollment
* 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 suggesting severe hypogeusia or ageusia at screening. 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

Additional Trial Information

Phase 2

Enrollment: 210 patients (estimated)

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Published Results

Timing and Resolution of Talquetamab-Related Dysgeusia in Relapsed/Refractory Multiple Myeloma (RRMM): Longitudinal Waterless Empirical Taste Test and Patient Reported Outcomes Profiles from Talisman

September 23, 2026

Methods: The phase 2 ongoing TALisman (NCT06500884) study has been previously described. Briefly, pts with RRMM receive experimental prophylaxis for 7 days before the first Tal step-up dose or Tal-only as a control. Co-primary endpoints are incidence of dysgeusia and severe dysgeusia, time to severe dysgeusia, and dysgeusia improvement at the end of 3 and 7 months per WETT.

Results: As of April 2026, 84.0% of 25 pts in the Tal-only cohort completed ≥3 cycles and 52.0% completed ≥6 cycles; 92.9% and 7.1% of 14 pts in the clonazepam (Tal+clon) cohort completed ≥3 and ≥6 cycles, respectively. Across cohorts, median age was 65.0 yrs; 59.0% were male. Adverse events led to dose modifications of Tal in 52.0% (Tal-only) and 64.3% (Tal+clon). By WETT, dysgeusia (any severity) occurred in 84.0% of pts with Tal-only and 92.9% with Tal+clon. Severe dysgeusia occurred in 56.0% and 85.7%, respectively. Median time to dysgeusia was 8 (Tal-only) and 4 days (Tal+clon); median time to severe dysgeusia was 75 and 8 days, respectively. The highest rates of dysgeusia/severe dysgeusia by WETT (Tal-only) occurred at cycle 3 (71.4%). The component WETT scores (Tal-only) with the highest mean change from baseline at timepoints through cycle 3 were sweet (–3.13), salty (–2.95), and sour (–2.18). Improvement in dysgeusia (any severity) was observed in 58.8% of pts with Tal-only and 58.3% with Tal+clon at the end of month 3, and in 66.7% (Tal-only) at the end of month 7. Further data on WETT taste components, patient-reported taste function, and oral health experience will be presented at the congress.

Conclusions: Dysgeusia by WETT improves as early as 3 months after Tal initiation, with 67% showing improvement after 7 months. Clonazepam prophylaxis did not improve incidence, onset, or resolution of dysgeusia, although low numbers limit definitive conclusions. The highest proportion of pts with dysgeusia/severe dysgeusia by WETT occurred during cycle 3, with the largest changes observed in the sweet, salty, and sour components of the taste profile. The innovative study design of TALisman enables investigation of additional prophylactic interventions for dysgeusia to help clarify expectations for pts, caregivers, and healthcare providers, and facilitate ongoing treatment and clinical benefit from Tal.

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

California

UCSF Helen Diller Comprehensive Cancer Center University of California San Francisco

San Francisco, CA

Recruitment on Hold

Colorado

Connecticut

Smilow Cancer Hospital at Yale New Haven

New Haven, CT

Recruitment on Hold

New York

Mount Sinai Hospital Tisch Cancer Institute

New York, NY

Recruitment on Hold

North Carolina

Duke Cancer Center Duke University Medical Center

Durham, NC

Recruitment on Hold

Ohio

Virginia

Massey Cancer Center Virginia Commonwealth University (VCU Health)

Richmond, VA

Recruitment on Hold

Washington

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