Study on the Effectiveness and Safety of bb2121 Compared to Standard Treatments in Patients with Relapsed and Refractory Multiple Myeloma

Sponsor: Celgene

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT03651128

This clinical trial is comparing a new treatment, bb2121, with standard treatments to see which is more effective and safe for patients with multiple myeloma that has returned or not responded to previous treatments. The study will involve about 381 participants.

Patient Parameters

Program Overview

This study is being conducted at multiple centers and involves randomly assigning participants to receive either the new treatment, bb2121, or one of the standard treatment regimens. The goal is to determine which treatment is more effective and safer for patients with relapsed and refractory multiple myeloma (RRMM).

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must understand and sign a consent form before any study procedures.
  • Must be willing to follow the study schedule and requirements, including long-term follow-up if assigned to the bb2121 treatment group.
  • Must have a confirmed diagnosis of multiple myeloma with measurable disease.
  • Must have received 2 to 4 previous treatments for multiple myeloma.
  • Must have been treated with specific drugs in the past and not responded to the last treatment.
  • Must have shown some response to at least one previous treatment.
  • Must be in good general health with a performance status of 0 or 1.
  • Must have recovered from any side effects of previous treatments, except for hair loss and mild nerve damage.
  • Must have good blood vessel access for a procedure called leukapheresis.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control.
  • Men must agree to use a condom during sexual contact and refrain from donating sperm.
  • Must be eligible for one of the standard treatment regimens being compared in the study.

Exclusion Criteria

  • Have any serious medical condition or mental illness that would prevent participation.
  • Have any condition that poses an unacceptable risk or makes it difficult to interpret study results.
  • Have a type of multiple myeloma that does not produce measurable proteins.
  • Have certain abnormal lab results, such as low blood cell counts or poor kidney function.
  • Have a history of other cancers unless free of disease for 5 years, except for certain skin or cervical cancers.
  • Have active or history of certain blood disorders or amyloidosis.
  • Have known involvement of the central nervous system with myeloma.
  • Have certain lung conditions or severe brain disorders.
  • Have received certain treatments recently, such as stem cell transplants or investigational drugs.
  • Have a history of severe heart problems or uncontrolled infections.
  • Have allergies to any of the study drugs or their components.
  • Be pregnant or breastfeeding.
  • Be unable or unwilling to follow certain safety measures if assigned to specific treatment regimens.

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