Study on Talquetamab for Patients with Relapsed or Hard-to-Treat Multiple Myeloma

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04634552

Provider View

This clinical trial is testing the effectiveness and safety of a drug called talquetamab for patients whose multiple myeloma has returned or is not responding to treatment. The study focuses on finding the best dose for future treatments.

Patient Parameters

Program Overview

The aim of this study is to determine how well the drug talquetamab works and how safe it is for patients with multiple myeloma that has come back or is difficult to treat. Researchers are looking at the best dose to use in future studies.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of multiple myeloma based on international guidelines.
  • For Part 3: Must have measurable multiple myeloma as determined by lab tests.
  • Must have a performance status score between 0 and 2, indicating full activity or some restriction in strenuous activities.
  • Women who can become pregnant must have a negative pregnancy test before starting the study and before the first dose of the study drug.
  • Must be willing and able to follow the study's rules and restrictions.

Exclusion Criteria

  • For Part 3: Patients in Cohort A and C must not have received CAR-T or T cell redirection therapy at any time. Patients in Cohort B and D must not have had T cell redirection therapy in the last 3 months.
  • Any side effects from previous cancer treatments should have returned to normal levels or be mild, except for hair loss or nerve damage.
  • Must not have taken more than 140 mg of prednisone or equivalent steroids in the 14 days before the first dose of the study drug (except for pre-treatment medication).
  • Must not have had a stroke or seizure in the 6 months before signing the consent form.

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