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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1.5 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response rate of abatacept + ixazomib citrate + dexamethasone in multiple myeloma patients
Secondary outcome measures
Incidence of adverse events assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
Overall survival
Progression-free survival
Other outcome measures
CD28 and CD86 expression assessed by flow cytometry
Serum kynurenine and IL-6 levels
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
~2590
Ixazomib Citrate
2012
Completed Phase 2
~200
Abatacept
2005
Completed Phase 4
~112150
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,499 Total Patients Enrolled
87 Trials studying Multiple Myeloma
29,905 Patients Enrolled for Multiple Myeloma
Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
30,843 Total Patients Enrolled
20 Trials studying Multiple Myeloma
2,085 Patients Enrolled for Multiple Myeloma
Jens Hillengass, MD, PhDPrincipal InvestigatorRoswell Park Cancer Institute
1 Previous Clinical Trials
18 Total Patients Enrolled
1 Trials studying Multiple Myeloma
18 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your bilirubin levels should be within a certain range, not too high.I cannot take ixazomib or abatacept due to health reasons.I do not have any ongoing infections.You must have a certain amount of a type of white blood cell called neutrophils in your blood.Your platelet count is at least 25,000 per cubic millimeter.I do not have active tuberculosis or a fungal infection.I can take care of myself and am up and about more than half of my waking hours.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have been treated with ixazomib before.You are not expected to live for more than 4 months.I have been diagnosed with plasma cell leukemia.I have HIV, hepatitis B, or hepatitis C.I've been cancer-free for over 2 years, except for certain skin cancers or early-stage cervical/breast cancer.Your AST and ALT levels in your blood are not more than 3 times the upper limit of normal.My multiple myeloma cells test positive for CD28 or CD86.My multiple myeloma has returned after treatment with a proteasome inhibitor, but I haven't been treated with a second one.Your kidneys can clean at least 30 milliliters of waste from your blood every minute.I am currently pregnant or breastfeeding.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (abatacept, ixazomib citrate, dexamethasone)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still being accepted into this research project?
"This clinical trial, which was first posted on 9/11/2018 and last updated on 9/29/2022, is not actively looking for participants according to the information available on clinicaltrials.gov. However, there are 1464 other trials that are currently enrolling patients."
Answered by AI
What are the potential side effects of Ixazomib Citrate?
"While there is some data indicating Ixazomib Citrate's safety, it received a score of 2 because this is only a phase 2 trial and thus efficacy has not been supported by any clinical data."
Answered by AI
Why is Ixazomib Citrate often prescribed?
"Ixazomib Citrate is a medication that's often used to treat ophthalmia, sympathetic. In some cases, it can also be effective in treating communicable diseases, branch retinal vein occlusion, and macular edema."
Answered by AI
How many people are taking part in this research project?
"This study is not taking new patients at this time, however, there are 827 other trials involving multiple myeloma and 637 trials for Ixazomib Citrate that are."
Answered by AI
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