Combination Therapy for Multiple Myeloma

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Plasma cell leukemia, HIV, HBV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

Duration: 28 days per cycle, repeated

15 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase II trial studies how well abatacept, ixazomib citrate, and dexamethasone work in treating patients with multiple myeloma that is resistant to chemotherapy. Abatacept may block certain proteins that are present on multiple myeloma cells that have been shown to protect against chemotherapy. Drugs used in chemotherapy, such as ixazomib citrate and dexamethasone, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving abatacept, ixazomib citrate, and dexamethasone may work better at treating patients with multiple myeloma resistant to chemotherapy.

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

Your bilirubin levels should be within a certain range, not too high.

Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria

I cannot take ixazomib or abatacept due to health reasons.

Unwilling or unable to follow protocol requirements

I do not have active tuberculosis or a fungal infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

28 days per cycle, repeated

Follow-up

Participants are monitored for safety and effectiveness after treatment completion, with follow-up at 30 days and then every 3 months.

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Abatacept
• Dexamethasone
• Ixazomib Citrate

Trial Overview The study tests the combination of abatacept (which may block protective proteins on cancer cells), ixazomib citrate, and dexamethasone (both chemotherapy drugs) in treating resistant multiple myeloma. The goal is to see if this combo is more effective than current treatments.

How Is the Trial Designed?

Group I: Treatment (abatacept, ixazomib citrate, dexamethasone) Experimental Treatment 4 Interventions

Patients receive abatacept IV over 30 minutes on day 1 of course 1, then SC on days 2, 8, 15, and 22 of course 1, and then on days 1, 8, 15, and 22 of subsequent courses. Patients also receive ixazomib citrate PO QD on days 1, 8, and 15 and dexamethasone on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Abatacept is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis
• Psoriatic arthritis

Approved in United States as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis
• Psoriatic arthritis

Approved in Canada as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis

Approved in Japan as Orencia for:

• Rheumatoid arthritis
• Polyarticular juvenile idiopathic arthritis

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Bristol-Myers Squibb

Industry Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

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