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Corticosteroid
Iberdomide + Elotuzumab + Dexamethasone for Multiple Myeloma (CC-220 Trial)
Phase < 1
Waitlist Available
Led By Samir Parekh, MBBS
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subject is ≥18 years of age at the time of signing the informed consent form (ICF)
Males who are sexually active with WOCBP must always use a latex or synthetic condom during any sexual contact with females of reproductive potential while taking Iberdomide (CC-220) and for up to 90 days after discontinuing Iberdomide (CC-220), even if they have undergone a successful vasectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
CC-220 Trial Summary
This trial is testing a new combination of drugs for people with myeloma who have progressed after other treatments. The new drugs are Iberdomide and Elotuzumab, and researchers think they might work better together than either alone. The trial will enroll 37 patients total, with 18 in a dose-escalation phase to find the best dose and 19 in a dose-expansion phase to test how well the drugs work.
Who is the study for?
Adults with relapsed/refractory multiple myeloma who have had 1-3 prior treatments including specific therapies (IMiD, proteasome inhibitor, anti-CD38 agent) can join. They must not be pregnant or breastfeeding and agree to use contraception. Excluded are those with certain other medical conditions, recent surgeries, active infections requiring long-term treatment, or previous Iberdomide/Elotuzumab use.Check my eligibility
What is being tested?
The trial tests a combination of Iberdomide (CC-220), Elotuzumab, and Dexamethasone in patients whose multiple myeloma has returned after treatment. It's an open-label study where everyone gets the same drugs but at different doses to find the highest dose that's safe (MTD). Up to 37 people will participate.See study design
What are the potential side effects?
Possible side effects include immune system reactions, blood count changes leading to increased infection risk or bleeding problems, fatigue, allergic responses to medication components and potential organ damage due to drug toxicity. The severity of side effects may vary among individuals.
CC-220 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I will use a condom during sex while on Iberdomide and for 90 days after stopping it.
Select...
I am able to care for myself and perform daily activities.
Select...
My multiple myeloma has worsened despite treatment.
Select...
I've had 1-3 treatments including IMiD, proteasome inhibitor, and anti-CD38.
Select...
My multiple myeloma has worsened despite treatment.
Select...
I am 18 years old or older.
CC-220 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Iberdomide dose limiting toxicity
Secondary outcome measures
Best Overall Response Rate (BOR)
Clinical Benefit Rate
Disease Control Rate
+5 moreCC-220 Trial Design
1Treatment groups
Experimental Treatment
Group I: Iberdomide, Elotuzumab and DexamethasoneExperimental Treatment3 Interventions
Dose-Finding: Patients will be enrolled in a 3+3 dose escalation cohort. Dose-Expansion: additionally enrolled patients at the recommended maximum tolerated dose of Iberdomide as was determined in Part 1 (Dose-Finding Phase).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
2007
Completed Phase 4
~2590
Elotuzumab
2016
Completed Phase 3
~800
Iberdomide
2021
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
Multiple Myeloma Research ConsortiumNETWORK
20 Previous Clinical Trials
1,352 Total Patients Enrolled
19 Trials studying Multiple Myeloma
1,299 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,636 Previous Clinical Trials
4,127,558 Total Patients Enrolled
87 Trials studying Multiple Myeloma
29,914 Patients Enrolled for Multiple Myeloma
Icahn School of Medicine at Mount SinaiLead Sponsor
858 Previous Clinical Trials
524,285 Total Patients Enrolled
9 Trials studying Multiple Myeloma
1,534 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't had major heart surgery in the last 8 weeks or any other major surgery in the last 4 weeks.You have more than 200 milligrams of M-protein in your urine in a 24-hour sample.Before joining the study, you must have a disease that can be measured or seen on tests.You had a very bad allergic reaction to a medication called IMiD in the past.Your liver enzymes are more than three times the normal level.I cannot tolerate blood clot prevention treatments during the study.You have a positive test for hepatitis B virus or hepatitis C virus, showing that you have an ongoing infection.Your corrected serum calcium level is higher than 13.5 mg/dL.I haven't taken any myeloma drugs or experimental drugs in the last 14 and 28 days, respectively.You have a severe allergy to dexamethasone, any ingredients in elotuzumab, or any similar medications.I haven't taken strong CYP3A inhibitors recently.I am 18 years old or older.You have high levels of M-protein in your blood.Your bilirubin level is too high.You are willing and able to adhere to the study visit schedule and other protocol requirements.You have more than 200 milligrams of M-protein in your urine over a 24-hour period.Your serum free light chain (sFLC) level is 10 mg/dL or higher, and the FLC ratio is abnormal.I haven't taken melphalan in the last 4 weeks.I will use a condom during sex while on Iberdomide and for 90 days after stopping it.It seems like the criterion you provided is incomplete. Can you please provide more details or specify the specific physical and laboratory test findings you are referring to?Your white blood cell count is too low without medication to help increase it.I am able to care for myself and perform daily activities.You are required to stay in a hospital for treatment of a mental or physical illness.If you could become pregnant, you must have a negative pregnancy test before starting the study drug.I do not have any serious health conditions that could make it unsafe for me to participate.I've had 1-3 treatments including IMiD, proteasome inhibitor, and anti-CD38.I agree to use contraception during and for 7 months after Elotuzumab treatment.My hemoglobin level is below 8 g/dL without recent blood transfusions.Your blood platelet count is less than 75 x 10^9/L without needing a blood transfusion in the past 3 days.My multiple myeloma has worsened despite treatment.I agree not to donate blood during and for 3 months after treatment.I haven't taken corticosteroids in the last 3 weeks.I have previously been treated with Iberdomide or Elotuzumab.I had a stem cell transplant over a year ago, with no graft issues or current immunosuppressive therapy.My kidney function is reduced with a creatinine clearance below 30 ml/min.You have high levels of specific proteins in your blood.I do not have severe numbness or pain in my hands or feet.I had a stem cell transplant using my own cells less than 12 weeks ago.I am on IV medication for an infection lasting more than 14 days.I have a blood disorder like MGUS, SMM, primary amyloidosis, Waldenström's macroglobulinemia, or POEMS syndrome.My multiple myeloma has worsened despite treatment.I have active plasma cell leukemia.I have no cancer history in the last 3 years, except for certain skin cancers or in-situ carcinoma.My only sign of plasma cell disorder is a single bone or soft tissue tumor.I am 18 years old or older.My multiple myeloma has spread to my brain or spinal cord.I have HIV/AIDS.Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
Research Study Groups:
This trial has the following groups:- Group 1: Iberdomide, Elotuzumab and 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 there any vacancies on this clinical experiment?
"According to clinicaltrials.gov, this study is not currently accepting new participants; the trial was first posted on October 15th 2022 and its last update occurred in late September of that same year. Yet, other 807 trials are recruiting patients at present time."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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