bb2121 for Multiple Myeloma
(KarMMa-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called bb2121 (also known as Idecabtagene vicleucel, Abecma, or ide-cel) for people with multiple myeloma, a type of blood cancer. The researchers aim to assess how well bb2121 works and its safety for those whose cancer has returned or hasn’t responded to other treatments. The trial includes different groups: those who have tried many treatments, those newly diagnosed, and those who have had specific past treatments like stem cell transplants. Suitable candidates for this trial are individuals with multiple myeloma who have experienced cancer recurrence or haven't succeeded with previous treatments and meet specific treatment history and response criteria. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop your current medications. However, you cannot use any systemic anti-myeloma drug therapy within 14 days before certain procedures in the trial. It's best to discuss your current medications with the trial team.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, you cannot have used any investigational agents or systemic anti-myeloma drug therapy within 14 days before certain trial procedures.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that bb2121, also known as idecabtagene vicleucel, was tested for safety in people with multiple myeloma. In earlier studies, many patients tolerated the treatment well, although some side effects occurred. Common side effects included low blood cell counts and tiredness. More serious side effects, such as infections or cytokine release syndrome (a reaction that can cause fever and low blood pressure), were less common but did occur.
The evidence indicates that while most patients experienced some side effects, many found the treatment manageable. Potential participants should consider these risks and discuss them with their healthcare provider before joining the trial.12345Why are researchers excited about this trial's treatment?
Researchers are excited about bb2121 for multiple myeloma because it offers a novel approach through CAR T-cell therapy. Unlike standard treatments like chemotherapy and stem cell transplants, bb2121 modifies a patient's own T-cells to attack cancer cells specifically, targeting the BCMA protein found on myeloma cells. This personalized treatment has the potential to deliver more effective and long-lasting results with fewer side effects. Additionally, certain arms of the trial explore the combination of bb2121 with other agents like lenalidomide and talquetamab, which could enhance its effectiveness and offer new hope for patients with different stages and responses to the disease.
What evidence suggests that this trial's treatments could be effective for multiple myeloma?
Research shows that bb2121, also known as ide-cel, is a promising treatment for multiple myeloma, particularly for patients who have not responded to other treatments. In this trial, participants will join different cohorts to evaluate bb2121 in various contexts, such as with or without autologous stem cell transplantation, in relapsed and refractory cases, and with lenalidomide maintenance. Studies have shown a high overall response rate. Specifically, one study reported that 89% of patients responded to the treatment. In another study, 84% of patients had a positive response, with more than half showing no signs of cancer afterward. These results suggest that bb2121 could be very effective for treating relapsed or hard-to-treat multiple myeloma, offering hope to patients with limited options.12678
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
This trial is for adults over 18 with Multiple Myeloma that's come back or didn't respond to treatment, including those who've had a stem cell transplant. It's not for those who've recently used investigational drugs, have certain medical conditions like organ failure or uncontrolled infections, are pregnant or breastfeeding, or have a history of blood clots.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Bridging Therapy
Anti-myeloma bridging treatment is allowed for disease control while bb2121 is being manufactured for cohorts 1, 2a, and 2b
Treatment
Participants receive bb2121 autologous CAR T cells infusion after lymphodepleting chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- bb2121
bb2121 is already approved in United States, European Union for the following indications:
- Relapsed or refractory multiple myeloma
- Relapsed or refractory multiple myeloma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Celgene
Lead Sponsor
Jay Backstrom
Celgene
Chief Medical Officer since 2016
MD
Mark Alles
Celgene
Chief Executive Officer since 2016
Bachelor's degree from Lock Haven University of Pennsylvania