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Monoclonal Antibodies
Combination Therapy for Multiple Myeloma
Phase 2
Recruiting
Led By Benjamin Derman, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
Subjects must receive insurance approval for pomalidomide and dexamethasone
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-24 months
Awards & highlights
Study Summary
This trial aims to see if a new combination of drugs can help people with multiple myeloma that has worsened despite other treatments. Participation would last 6-24 months.
Who is the study for?
Adults with relapsed multiple myeloma who've had at least two prior treatments can join this trial. They should be in decent health, understand the study, and agree to use contraception. Those with certain allergies, infections, bleeding disorders or unstable heart conditions cannot participate.Check my eligibility
What is being tested?
Researchers are testing a combination of belantamab mafodotin, carfilzomib, pomalidomide, and dexamethasone on patients whose multiple myeloma has worsened after standard treatment including CAR T-cell therapy.See study design
What are the potential side effects?
Possible side effects include eye problems like blurry vision or dry eyes (especially for contact lens wearers), blood disorders such as anemia or clotting issues, increased risk of infection due to immune suppression from dexamethasone and potential heart complications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and am up and about more than half of my waking hours.
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My insurance covers pomalidomide and dexamethasone.
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My organ functions are within the normal range as required.
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My multiple myeloma has worsened after at least 2 treatments.
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All my side effects from previous cancer treatments are mild, except for hair loss and some nerve pain.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of Overall Response (Prior CAR T-Cell Therapy Cohort)
Rate of Very Good Partial Response (No Prior CAR T-Cell Therapy Cohort)
Secondary outcome measures
Frequency and Severity of Adverse Events (AEs)/ Serious Adverse Events
Minimal Residual Disease Negativity Rate
Overall Response Rate
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Cohort 2: Prior CAR T-Cell TherapyExperimental Treatment4 Interventions
This cohort will consist of 64 participants who have had prior CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
Group II: Cohort 1: No Prior CAR T-Cell TherapyExperimental Treatment4 Interventions
This cohort will consist of 19 participants who have not had CAR T-Cell Therapy. Participants will receive belantamab mafodotin, carfilzomib, pomalidomide and dexamethasone.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belantamab mafodotin
2019
Completed Phase 1
~10
Carfilzomib
2017
Completed Phase 3
~1440
Pomalidomide
2011
Completed Phase 2
~1020
Dexamethasone
2007
Completed Phase 4
~2590
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,694 Total Patients Enrolled
16 Trials studying Multiple Myeloma
1,886 Patients Enrolled for Multiple Myeloma
GlaxoSmithKlineIndustry Sponsor
4,755 Previous Clinical Trials
8,070,752 Total Patients Enrolled
47 Trials studying Multiple Myeloma
6,350 Patients Enrolled for Multiple Myeloma
AmgenIndustry Sponsor
1,371 Previous Clinical Trials
1,378,135 Total Patients Enrolled
96 Trials studying Multiple Myeloma
20,657 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had radiotherapy to multiple sites within the last 3 weeks.I have a mild eye surface condition, not severe corneal disease.I do not have Hepatitis B, or if I do, it meets specific criteria.I do not have any active kidney problems affecting my safety, except for protein in my urine due to multiple myeloma.I do not have any current bleeding from my internal organs or mucous membranes.I have not had major surgery in the last 2 weeks.I am willing to follow the safety rules for my cancer treatment.My liver is stable and I don't have serious liver conditions.My insurance covers pomalidomide and dexamethasone.I do not have severe nerve pain or damage.My organ functions are within the normal range as required.I do not have active hepatitis C or have been successfully treated for it.I have been treated with specific cancer drugs like lenalidomide or bortezomib.I have not responded to either carfilzomib or pomalidomide, but not both, and haven't had CAR T-cell therapy.I had CAR T-cell therapy targeting BCMA as my last treatment and my cancer has progressed.I have been diagnosed with Waldenström's macroglobulinemia, systemic amyloidosis, POEMS syndrome, or plasma cell leukemia.My condition did not improve after taking belantamab mafodotin.I am not allergic to belantamab mafodotin or similar drugs.I am a man willing to follow strict birth control rules during and after the study.I am using birth control as required by local laws for clinical study participants.I can take care of myself and am up and about more than half of my waking hours.I have no other cancers, or they've been stable for 2 years, except for treated non-melanoma skin cancer.My multiple myeloma has worsened after at least 2 treatments.All my side effects from previous cancer treatments are mild, except for hair loss and some nerve pain.I haven't taken any experimental drugs or myeloma treatments in the last 14 days.You have HIV unless your T-cell count, viral load, and overall health meet specific requirements set by the study doctor.I do not have serious heart problems or uncontrolled high blood pressure.I do not have any infections that need treatment.You are expected to live for at least three more months.I am 18 years old or older.You have certain levels of abnormal proteins in your blood or urine that can be measured.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: No Prior CAR T-Cell Therapy
- Group 2: Cohort 2: Prior CAR T-Cell Therapy
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.
Has the FDA approved all participants in this trial?
"Our team's evaluation of the safety of all participants involved in this trial is a score of 2 – indicating that while there is some evidence to support its security, clinical data has not yet supported its efficacy."
Answered by AI
Are enrollees being accepted for this medical experiment at the present time?
"As indicated in the clinicaltrials.gov registry, recruitment for this medical experiment has been halted since March 23rd 2023. The trial was originally posted on July 1st 182023 and is no longer looking to recruit patients; however, there are 813 other trials that remain active participants."
Answered by AI
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