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Monoclonal Antibodies

Preventive Treatments for Talquetamab-Related Oral Toxicity in Multiple Myeloma (Talisman Trial)

Phase 2

Recruiting

Research Sponsored by Janssen Research & Development, LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Documented evidence of progressive disease based on investigator's determination of response by IMWG criteria on or after their last regimen

* Multiple myeloma (MM) according to IMWG diagnostic criteria

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to find ways to prevent and reduce the occurrence, severity, and duration of a side effect called distorted taste caused by talquetamab. The study also aims to better understand the signs

Who is the study for?

This trial is for individuals with multiple myeloma who have seen their disease progress after treatment. They should be relatively active (able to care for themselves or up and about more than half of the day) and able to follow certain lifestyle restrictions. Those who've had prior treatments with proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies can join.

What is being tested?

The study aims to find out which preventive treatments are best at reducing taste distortion caused by talquetamab in patients with multiple myeloma. Participants will receive one of three prophylactic treatments alongside talquetamab to see which is most effective.

What are the potential side effects?

Talquetamab may cause distorted taste (dysgeusia), but this trial specifically investigates how to prevent or lessen this side effect using different prophylactic measures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has worsened after my last treatment, as confirmed by my doctor.

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I have been diagnosed with multiple myeloma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of Participants Who Report Resolution/Improvement of Dysgeusia During the Prophylaxis Treatment Phase

Percentage of Participants With Occurrence of Dysgeusia as Assessed by the Total Waterless Empirical Taste Test (WETT) Testing Score During the Prophylaxis Treatment Phase

Percentage of Participants With Occurrence of Severe Dysgeusia During the Prophylaxis Treatment Phase

+1 more

Secondary study objectives

Change From Baseline in WETT Testing Score Over Time

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 items (EORTC-QLQ-C30) Domains Scores Over Time

Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Oral Health (EORTC-QLQ-OH15) Domains Scores Over Time

+20 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Cohort D: Prophylaxis C and TalquetamabExperimental Treatment2 Interventions

Participants with RRMM (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. The Talquetamab treatment phase will continue from C1D1 until disease progression, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.

Group II: Cohort C: Prophylaxis B and TalquetamabExperimental Treatment2 Interventions

Participants with RRMM (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. The Talquetamab treatment phase will continue from C1D1 until disease progression, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.

Group III: Cohort B: Prophylaxis A and TalquetamabExperimental Treatment2 Interventions

Participants with RRMM (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. The Talquetamab treatment phase will continue from Cycle 1 Day 1 (C1D1) until disease progression, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.

Group IV: Cohort A: TalquetamabActive Control1 Intervention

Participants with relapsed or refractory multiple myeloma (RRMM) (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, unacceptable toxicity, withdrawal of consent, or end of study, whichever occurs first.

0 / 2Eligibility criteria met