A Phase 1 Study to Evaluate bb2121 in Patients with High Risk, Newly Diagnosed Multiple Myeloma KARMMA-4
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What's the purpose of this trial?

This is a Phase 1, open-label, multicenter study to evaluate the safety and to determine the optimal dose of bb2121 in patients with newly diagnosed multiple myeloma who are specifically considered ‘high risk’ (meaning that the disease stage and genetic testing are linked to a poor prognosis).

This trial is currently open and accepting patients.


What's being studied?

  • Cyclophosphamide is a chemotherapy agent used in the treatment of cancer.
  • Dexamethasone is a steroid given in conjunction with some cancer treatments.
  • Fludarabine is a chemotherapy agent used in the treatment of cancer.
  • Idecabtagene Vicleucel (ide-cel, bb2121) is a Chimeric Antigen Receptor (CAR) T cell therapy. Your own T cells are removed and altered in a lab to recognize BCMA, a protein carried by multiple myeloma cells.
  • Lenalidomide is an immunomodulatory drug that helps your body fight cancer by stimulating antibody formation and also by slowing tumor growth.

What will happen during the trial?

This trial is seeking approximately 30-60 people living with newly diagnosed multiple myeloma who are specifically considered ‘high risk’ (meaning that the disease stage and genetic testing are linked to a poor prognosis) to participate.

This trial is organized into a single arm, which means that all participants are planned to receive bb2121.

This trial is organized into four parts: Pre-Treatment, Treatment, Post-Treatment, and Survival Follow-up.

Pre-Treatment – During this part of the trial, you will receive four cycles of an anti-myeloma treatment regimen. A cycle is a period of treatment followed by a period of rest (no treatment) that is repeated on a regular schedule. Participants will undergo the collection of their T cells (leukapheresis) to make into bb2121 after the third cycle of anti-myeloma therapy. The study doctor will determine which of the anti-myeloma regimens you will receive before leukapheresis.

Treatment – During this part of the trial you will receive lymphodepleting chemotherapy (chemotherapy treatment that removes some of your own immune cells, making space for the bb2121 T cells to grow in your body, and to increase the chances of your body’s ability to accept the bb2121 T cells) and bb2121. Approximately 5 days before you receive bb2121, you will receive three consecutive days of lymphodepleting chemotherapy. This is necessary to remove some of your immune cells to make room for bb2121, and to help your body to accept the bb2121 cells. When you receive bb2121, you will be hospitalized for approximately 14 days so that your study doctor can monitor you closely for side effects.

Post-Treatment - Once you are discharged from the hospital, you will need to stay within a 30 minute drive from your treating hospital and have a dedicated caregiver staying with you for the remainder of the 30 days following your bb2121 treatment. You will need to visit your study site for follow-up monthly for the first 6 months, then every 3 months for the first two years. Your study doctor may prescribe a maintenance anti-myeloma therapy like Lenalidomide for you during this time.

Follow-up – Study staff will continue to contact you approximately every 3 months to obtain  information on how you are doing up until 2 years after the last patient receives bb2121. They may ask you to undergo testing to see if bb2121 cells are still present in your body, and if they have changed in any way.

There is an optional longer term follow-up safety study that may last 15 years


Additional Trial Information

Phase 1

Enrollment: 60 patients (estimated)

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You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required. Create your account or call us today for help (888) 828-2206.

  • Participants must be newly diagnosed with high risk multiple myeloma, and have received 3 or less cycles of certain types of induction (initial) treatment as defined by study requirements.
  • Patients must not have non-secretory myeloma, and must meet the measurable disease criteria for this study.
  • Participants must not have central nervous system involvement of their myeloma.
  • Participants must have adequate bone marrow, kidney, liver, lung and cardiac function to safely participate in this study.
View Additional Criteria

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Colorado

Florida

Mayo Clinic (Jacksonville)

Jacksonville, FL

Open and Accepting

Georgia

Winship Cancer Institute of Emory University

Atlanta, GA

Open and Accepting

New Jersey

John Theurer Cancer Center Hackensack Meridian Health

Hackensack, NJ

Open and Accepting

Tennessee

Sarah Cannon TriStar Centennial Medical Center

Nashville, TN

Open and Accepting

Trial Links

Read the latest news and updates on this trial.

Highly Refractory Myeloma Has Deep and Durable Responses With Ide-cel

December 05, 2020

Patients with heavily pretreated multiple myeloma maintained durable responses with the chimeric antigen receptor (CAR) T-cell therapy idecabtagene vicleucel (ide-cel; bb2121) in updated findings presented from the phase 1 CRB-401 trial (NCT02658929).

Read more
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