What's the purpose of this trial?
The goal of this clinical trial is to learn more about the safety and effectiveness of investigational drug bb2121 in combination with lenalidomide maintenance when given to participants with relapsed and refractory or high-risk multiple myeloma.
This trial has temporarily put patient recruitment on hold.
What will happen during the trial?
This trial is organized into five main groups, or cohorts. Depending on when their myeloma was diagnosed, and the type and quantity of treatment previously received, participants will be assigned to one of the cohorts. Cohorts 1 and 3 are accepting patients.
Participants in all cohorts are planned to receive bb2121 alone or bb2121 in combination with lenalidomide. The study can be broken down into a few different parts.
Before bb2121 administration - During this part of the trial, participants will be screened for eligibility, undergo a collection of their T cells (leukapheresis) to make into investigational drug bb2121 and undergo other evaluations before the treatment part. Depending on the cohort they are placed in , participants may receive Lenalidomide or another approved treatment as anti-myeloma therapy while waiting for their T cells to be processed.
bb2121 administration - During this part of the trial, participants will receive lymphodepleting chemotherapy and investigational drug bb2121. The lymphodepleting chemotherapy is used to remove some immune cells, making space for the investigational bb2121 T cells to grow in the body, and to increase the chances of the body’s ability to accept the investigational bb2121 T cells. When receiving investigational drug bb2121, participants will be hospitalized for approximately 14 days so that the study doctors can monitor closely for side effects.
After bb2121 administration - Once discharged from the hospital, participants will need to stay within a 30 minute drive from the treating hospital and have a dedicated caregiver staying with them for the remainder of the 30 days following investigational drug bb2121 treatment. Participants will need to visit the study site for follow-up monthly for the first 6 months, then every 3 months for the first two years. The study doctor may prescribe a maintenance anti-myeloma therapy Lenalidomide during this time.
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.
- meet prior line of therapy criteria.
- Participants in cohort 1 must have had 3 or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and an anti-CD38 antibody.
- Participants in cohort 3 must have previously had an autologous stem cell transplant, including a proteasome inhibitor and immunomodulatory drug induction.
- do not have central nervous system involvement of your myeloma.
- do not have nonsecretory multiple myeloma.
- have adequate bone marrow, cardiac, kidney, and lung function as described in the trial criteria.
- Suboptimal response to autologous stem cell transplant.
Additional eligibility criteria apply and can be explained by the study doctor.
Additional Trial Information
Phase 2
Enrollment: 265 patients (estimated)
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