Study on the Effectiveness and Safety of bb2121 for Patients with Relapsed, Refractory, or High-Risk Multiple Myeloma

Sponsor: Celgene

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03601078

Provider View

This clinical trial is testing a new treatment called bb2121 for patients with multiple myeloma that has returned or not responded to previous treatments, as well as those with high-risk multiple myeloma. The study aims to evaluate how well the treatment works and its safety.

Patient Parameters

Program Overview

This study is exploring the effectiveness and safety of a new treatment, bb2121, for patients with multiple myeloma that has either returned after treatment or not responded to previous treatments. The study includes several groups of participants, each with different treatment histories and conditions. Participants will receive bb2121, and some may also receive additional medications like talquetamab or lenalidomide. The study will involve about 264 participants across different groups, each with specific criteria based on their previous treatments and responses.

Description

The study is divided into different groups based on participants' treatment history and response to previous therapies:

  • Cohort 1: Includes patients with relapsed or refractory multiple myeloma who have had at least three previous treatments. These patients may also receive a bridging therapy with talquetamab while waiting for bb2121 to be prepared.
  • Cohort 2: Includes patients whose multiple myeloma progressed within 18 months of their initial treatment. This group is further divided into:
    • Cohort 2a: Patients who had an autologous stem cell transplant (ASCT) and early relapse.
    • Cohort 2b: Patients who did not have ASCT but had early relapse.
    • Cohort 2c: Patients who had an inadequate response to ASCT during their initial treatment.
  • Cohort 3: Includes newly diagnosed multiple myeloma patients who had a suboptimal response to ASCT and may receive lenalidomide maintenance therapy.

Participants will be monitored for the effectiveness of bb2121 in controlling their multiple myeloma and for any side effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • For Cohorts 1 and 2, must have measurable multiple myeloma.
  • Specific requirements for each cohort:
    • Cohort 1: At least three previous treatments, including specific drugs, and evidence of disease progression.
    • Cohort 2: Only one previous treatment, with early relapse or inadequate response to ASCT.
    • Cohort 3: Newly diagnosed, with specific treatment history and response.
  • Must have a good performance status and recovery from previous treatment side effects.

Exclusion Criteria

  • Recent use of investigational agents or certain treatments.
  • Known central nervous system involvement with myeloma.
  • Certain medical conditions, including heart problems and infections.
  • Previous treatments with specific therapies or transplants.
  • Positive for certain infections like HIV or hepatitis.
  • Pregnant or breastfeeding women.
  • Allergies to components of the study treatment.

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