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Immunomodulatory Agent
Iberdomide Combo for Multiple Myeloma (COMMANDER Trial)
Phase 1 & 2
Recruiting
Led By Luciano Costa, MD, PhD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Prior AHCT 100-180 days prior to initiation of protocol-directed therapy
Confirmation of newly diagnosed multiple myeloma (MM) with 1-2 prior regimens utilized in induction that included an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI) combined or in different regimens
Timeline
Screening 3 weeks
Treatment Varies
Follow Up four years
Awards & highlights
COMMANDER Trial Summary
This trial is looking at a new way to treat MM by using iberdomide in combination with other agents to achieve and sustain MRD (-).
Who is the study for?
Adults diagnosed with multiple myeloma who've had 1-2 prior treatments including an immunomodulatory agent and a proteasome inhibitor, and have undergone autologous hematopoietic cell transplantation (AHCT) within the past 100-180 days. Participants must show minimal residual disease, be in partial response or better post-AHCT, and have adequate organ function. Pregnant women, those with certain other medical conditions or infections, or previous negative reactions to specific drugs are excluded.Check my eligibility
What is being tested?
The trial is testing combinations of the oral drug Iberdomide with Daratumumab, Dexamethasone, and Carfilzomib for multiple myeloma patients post-AHCT. The goal is to achieve and maintain undetectable levels of cancer cells (MRD-negative status), which could lead to long-term disease control.See study design
What are the potential side effects?
Potential side effects include but are not limited to: lowered blood counts leading to increased infection risk; liver issues; fatigue; allergic reactions; heart problems like hypertension or arrhythmias; neuropathy (nerve pain); gastrointestinal symptoms such as nausea or diarrhea.
COMMANDER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I had a stem cell transplant 100-180 days before starting the treatment in this study.
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I have multiple myeloma and was treated with both an IMiD and a PI in 1-2 prior treatments.
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I am able to get out of my bed or chair and move around.
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My treatment for multiple myeloma has shown improvement.
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My initial tests showed measurable signs of multiple myeloma.
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My liver tests are within normal limits.
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My blood tests show enough platelets and neutrophils.
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My condition has not worsened before or after my stem cell transplant.
COMMANDER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose limiting toxicity
MRD conversion ( to < 10-5 MM-associated molecules)
COMMANDER Trial Design
2Treatment groups
Experimental Treatment
Group I: Iberdomide, Daratumumab and Dexamethasone (Regimen A)Experimental Treatment3 Interventions
Iberdomide dosed according to cohort assignment days 1-21. Dexamethasone 40 mg oral or intravenously (20 mg for participants 70 or older) on days 1,8,15 and 22 Darartumumab and hyalurnonidase-fihj 1,800mg/30,000 units subcutaneously on days 1,8,15,22 (cycles 1,2) or on days 1,15 (cycles 3-6)
Group II: Iberdomide, Carfilzomib, Daratumumab and Dexamethasone (Regimen B)Experimental Treatment4 Interventions
Iberdomide dosed according to cohort assignment days 1-21. Dexamethasone 40 mg oral or intravenously (20 mg for participants 70 or older) on days 1,8,15 and 22 Darartumumab and hyalurnonidase-fihj 1,800mg/30,000 units subcutaneously on days 1,8,15,22 (cycles 1,2) or on days 1,15 (cycles 3-6) Carfilzomib dosed intravenously dosed according to cohort assignment on days 1, 8, 15 (Consistent with standard practice, the very first dose of carfilzomib (cycle 1 day 1) must be 20 mg/m^2).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iberdomide
2021
Completed Phase 1
~60
Daratumumab
FDA approved
Dexamethasone
FDA approved
Carfilzomib
FDA approved
Find a Location
Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,589 Previous Clinical Trials
2,280,274 Total Patients Enrolled
10 Trials studying Multiple Myeloma
6,955 Patients Enrolled for Multiple Myeloma
Luciano Costa, MD, PhDPrincipal InvestigatorUniversity of Alabama at Birmingham
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am allergic to Captisol®, a substance used in some cancer drugs.I am older than 18.I had a stem cell transplant 100-180 days before starting the treatment in this study.I have had a stroke before or a TIA in the last year.My multiple myeloma has affected my brain or spinal cord.You have been diagnosed with hepatitis C, unless you have been successfully treated for it.My multiple myeloma did not respond to previous CD38 antibody or carfilzomib treatments.I cannot take Aspirin or Acyclovir due to allergies or side effects.You have a positive test for hepatitis B surface antigen (HBsAg).My high blood pressure is not controlled, even with medication.I have been diagnosed with a specific blood disorder but not active multiple myeloma.I have multiple myeloma and was treated with both an IMiD and a PI in 1-2 prior treatments.I have been diagnosed with interstitial lung disease.My treatment for multiple myeloma has shown improvement.My initial tests showed measurable signs of multiple myeloma.My kidney function, measured by creatinine clearance, is sufficient.Your heart's electrical activity shows a longer QT interval than normal on the screening ECG.I am able to get out of my bed or chair and move around.I have not had major surgery or radiotherapy in the last 28 days.I have not had an infection needing treatment in the last 14 days.I haven't had cancer besides blood cancer in the last 3 years, with some exceptions.I have not had severe nerve pain or tingling in the last 28 days.I agree to regular pregnancy tests, using birth control during treatment, and if male, not to donate sperm.I haven't had recent severe heart issues or uncontrolled heart conditions.My minimal residual disease level is detectable and was tested 2-4 months after my stem cell transplant.I haven't taken strong medication affecting liver enzymes or certain drug transporters for 14 days.My liver tests are within normal limits.My blood tests show enough platelets and neutrophils.My condition has not worsened before or after my stem cell transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Iberdomide, Carfilzomib, Daratumumab and Dexamethasone (Regimen B)
- Group 2: Iberdomide, Daratumumab and Dexamethasone (Regimen A)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- 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.
Is this research study actively seeking participants?
"Based on the information hosted at clinicaltrials.gov, this study is no longer seeking to enrol participants, despite being first posted in December 1st 2022 and last modified on October 31st 2022. However, there are 807 other studies that remain open for recruitment currently."
Answered by AI
Are there numerous American locales hosting this research endeavor?
"The trial is currently running at Oregon Health and Science University in Portland, Duke University in Durham, Vanderbilt University Medical College in Nashville as well as 6 additional sites."
Answered by AI
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