Study Comparing Two Treatment Approaches for Newly Diagnosed Multiple Myeloma Without Planned Stem Cell Transplant

Sponsor: Janssen Research & Development, LLC

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04923893

Provider View

This clinical trial is comparing two treatment plans for patients with newly diagnosed multiple myeloma who are not planning to undergo a stem cell transplant. The study aims to see which approach is more effective in preventing the cancer from worsening.

Patient Parameters

Program Overview

The study is testing two different treatment plans for people with newly diagnosed multiple myeloma who are not planning to have a stem cell transplant. One group will receive a combination of drugs called Bortezomib, Lenalidomide, and Dexamethasone (VRd) followed by a single dose of a CAR-T cell therapy called cilta-cel. The other group will receive the same initial VRd treatment followed by ongoing treatment with Lenalidomide and Dexamethasone (Rd). The main goal is to see which treatment plan helps patients live longer without their cancer getting worse.

Description

Multiple myeloma is a type of cancer that affects plasma cells in the bone marrow. This study is exploring two treatment options for patients who are newly diagnosed and not planning to have a stem cell transplant. The first option involves starting with a combination of three drugs—Bortezomib, Lenalidomide, and Dexamethasone (VRd)—and then receiving a single dose of a CAR-T cell therapy called cilta-cel, which targets a protein on cancer cells. The second option is to start with the same VRd combination and then continue with just Lenalidomide and Dexamethasone (Rd) as maintenance therapy. The study will last about 12 years and 5 months and will include various assessments to monitor the patients' health and the effectiveness of the treatments. Safety will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of multiple myeloma.
  • Have measurable disease based on specific blood or urine tests.
  • Be in good general health with a performance status score of 0 or 1.
  • Not planning to undergo a stem cell transplant due to age, other health conditions, or personal choice.
  • Women of childbearing potential must have negative pregnancy tests and agree to use birth control.
  • Meet specific blood and organ function criteria based on lab tests.

Exclusion Criteria

  • Have a frailty score of 2 or higher.
  • Have significant nerve pain or damage.
  • Have a history of brain or spinal cord involvement by multiple myeloma.
  • Have had a stroke or seizure in the past 6 months.
  • Test positive for HIV.
  • Have received a live vaccine in the past 4 weeks.
  • Require continuous oxygen support.
  • Have hepatitis B or C infection.
  • Have previously received CAR-T therapy or treatments targeting BCMA.

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