Combination Therapy for Multiple Myeloma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a combination of three treatments—abatacept (Orencia), ixazomib citrate (Ninlaro), and dexamethasone—to evaluate their effectiveness against multiple myeloma, a cancer affecting bones and the immune system. The goal is to determine if this combination is more effective for patients whose disease does not respond to standard chemotherapy. Patients who have tried other treatments without success and whose multiple myeloma continues to progress might be suitable candidates, especially if their cancer cells have specific markers (proteins) called CD28 or CD86. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that each component of this treatment—abatacept, ixazomib citrate, and dexamethasone—has undergone safety studies in humans. Ixazomib citrate, specifically, is approved for treating relapsed or refractory multiple myeloma, indicating its safety for similar use. Studies have shown that ixazomib, when combined with dexamethasone, is generally well-tolerated, with many patients experiencing only mild side effects.
For abatacept, less direct information is available, but its inclusion in this study suggests that previous research has deemed it safe enough for further testing. The trial phase also indicates that abatacept has been tested in earlier studies and found to have a safety profile that permits continued research.
Overall, while each drug in this treatment has been studied individually, the combination in this specific trial is still under investigation to ensure its safety and effectiveness for patients.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this combination therapy for multiple myeloma because it introduces a fresh approach by combining abatacept with ixazomib citrate and dexamethasone. Unlike standard treatments, which often focus solely on proteasome inhibition (like bortezomib) or immunomodulation, this regimen adds abatacept, a T-cell modulator. This unique combination aims to enhance the immune response while simultaneously targeting cancer cells, potentially offering a new pathway to manage the disease more effectively. Furthermore, abatacept's dual delivery method—initially intravenous and then subcutaneous—could improve patient convenience and adherence.
What evidence suggests that this combination therapy could be effective for multiple myeloma?
This trial will evaluate the combination of abatacept, ixazomib citrate, and dexamethasone as a treatment for multiple myeloma that doesn't respond to chemotherapy. Abatacept blocks proteins on cancer cells that help them resist treatment. Ixazomib citrate, a proteasome inhibitor, stops cancer cells from growing and dividing. Dexamethasone, a steroid, can kill cancer cells by weakening their defenses. Previous studies have shown that ixazomib citrate is effective in patients whose multiple myeloma has returned. Using these drugs together in this trial could potentially improve outcomes for patients with resistant multiple myeloma.12467
Who Is on the Research Team?
Jens Hillengass, MD, PhD
Principal Investigator
Roswell Park Cancer Institute
Are You a Good Fit for This Trial?
This trial is for patients with multiple myeloma that hasn't responded to previous chemotherapy. Participants must have been cancer-free from other types for 2 years, agree to use birth control, and not have been treated with ixazomib or similar drugs before. They should be free of infections, have a certain level of blood cells and organ function, and their cancer cells must show specific proteins.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive abatacept, ixazomib citrate, and dexamethasone. Abatacept is administered IV on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and on days 1, 8, 15, and 22 of subsequent courses. Ixazomib citrate is taken orally on days 1, 8, and 15, and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then every 3 months.
What Are the Treatments Tested in This Trial?
Interventions
- Abatacept
- Dexamethasone
- Ixazomib Citrate
Abatacept is already approved in European Union, United States, Canada, Japan for the following indications:
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis
- Psoriatic arthritis
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis
- Psoriatic arthritis
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis
- Rheumatoid arthritis
- Polyarticular juvenile idiopathic arthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Roswell Park Cancer Institute
Lead Sponsor
Bristol-Myers Squibb
Industry Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania