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Immunomodulator

Combination Therapy for Multiple Myeloma

Phase 2

Waitlist Available

Led By Jens Hillengass, MD, PhD

Research Sponsored by Roswell Park Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must be free of systemic infection

Have an Eastern Cooperative Oncology Group (ECOG) performance status of =< 2 at study entry

Must not have

Inability to take ixazomib or abatacept

Known active tuberculosis or fungal infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a combination of drugs to treat patients with multiple myeloma that has resisted chemotherapy. One drug, abatacept, may block proteins that protect myeloma cells from chemotherapy. The other drugs, ixazomib citrate and dexamethasone, work in different ways to stop the growth of myeloma cells. The hope is that the combination of these drugs will be more effective than chemotherapy alone.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include typical reactions to chemotherapy like nausea, fatigue, increased risk of infection due to lowered immunity, possible liver issues indicated by changes in blood tests results, as well as any unique reactions related to abatacept such as potential immune system complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have any ongoing infections.

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I can take care of myself and am up and about more than half of my waking hours.

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My multiple myeloma cells test positive for CD28 or CD86.

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My multiple myeloma has returned after treatment with a proteasome inhibitor, but I haven't been treated with a second one.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take ixazomib or abatacept due to health reasons.

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I do not have active tuberculosis or a fungal infection.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have been treated with ixazomib before.

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I have been diagnosed with plasma cell leukemia.

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I have HIV, hepatitis B, or hepatitis C.

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I am currently pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response Rate of Abatacept + Ixazomib Citrate + Dexamethasone in Multiple Myeloma Patients

Secondary study objectives

Incidence of Adverse Events Assessed Using National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0

Overall Survival

Progression-free Survival

Other study objectives

CD28 and CD86 Expression Assessed by Flow Cytometry

Serum Kynurenine and IL-6 Levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (abatacept, ixazomib citrate, dexamethasone)Experimental Treatment4 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Abatacept

2005

Completed Phase 4

~112250