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Iberdomide Maintenance Therapy for Multiple Myeloma
Phase 2
Recruiting
Led By Sarah A Holstein, MD, PhD
Research Sponsored by University of Nebraska
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must have a documented history of a diagnosis of active Multiple Myeloma (MM)
Measurable disease documented at time of diagnosis (prior to induction and ASCT) as defined as: i. M-protein (serum and/or urine protein electrophoresis (SPEP or UPEP)): SPEP ≥ 0.5 g/dL or UPEP ≥ 200 mg/24 hours and/or ii. Light chain MM without measurable disease in the serum or urine: serum immunoglobulin free light chain ≥ 10 mg/dL (100 mg/L) and abnormal serum immunoglobulin kappa-lambda free light chain ratio
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial will study if a drug called iberdomide is safe and effective when given to people after they have a stem cell transplant to treat their myeloma. A maximum of 38 people will be enrolled.
Who is the study for?
This trial is for adults with Multiple Myeloma who've had a stem cell transplant and are in partial or better response. They must have good organ function, no prior progression after initial therapy, and not be on other clinical trials. Women of childbearing potential must use contraception; men must agree to abstain or use condoms.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of iberdomide as maintenance therapy post-stem cell transplant in Multiple Myeloma patients. It will continue until disease progression or unacceptable toxicity occurs, comparing its results potentially with lenalidomide maintenance.See study design
What are the potential side effects?
While specific side effects for iberdomide aren't listed here, similar drugs can cause blood clots, nerve damage (neuropathy), low blood counts leading to increased infection risk, fatigue, rash, dizziness, constipation or diarrhea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with active Multiple Myeloma.
Select...
My cancer was measurable by specific protein levels in my blood or urine at diagnosis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of subjects who are able to complete at least one year of therapy
Secondary outcome measures
MRD-negativity rate at Day 100
MRD-negativity rate at One Year
MRD-negativity rate at Two Years
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: IberdomideExperimental Treatment1 Intervention
Iberdomide will be dosed at 1.0 mg PO daily for days 1-21 of a 28-day cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Iberdomide
2021
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
University of NebraskaLead Sponsor
539 Previous Clinical Trials
1,144,696 Total Patients Enrolled
9 Trials studying Multiple Myeloma
1,000,324 Patients Enrolled for Multiple Myeloma
Sarah A Holstein, MD, PhDPrincipal InvestigatorUniversity of Nebraska
Sarah Holstein, MD/PhDPrincipal InvestigatorUniversity of Nebraska
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at least 18 years old, or 19 if I live in Nebraska.I have a type of blood cancer that doesn't produce typical markers.I can become pregnant and agree to use two forms of birth control or practice abstinence.I have been diagnosed with active Multiple Myeloma.My cancer was measurable by specific protein levels in my blood or urine at diagnosis.Within the past 14 days, you have had low levels of certain blood cells, high levels of calcium in your blood, or liver or kidney problems.I do not have severe nerve damage, major gut issues affecting drug absorption, or trouble swallowing pills.You have not started treatment for multiple myeloma within the past year, have not had disease progression after initial treatment, have not had a specific type of stem cell or organ transplant, and have a good performance status.Criterion: You have taken certain medications that weaken your immune system within the last 14 days, or you have used specific strong medications or herbs in the last two weeks. You also have a certain virus, hepatitis, or have taken a certain medication before.I agree to follow strict rules to prevent pregnancy and not donate sperm or blood while on and after the study treatment.I have been cancer-free for over 5 years, except for certain non-aggressive types.You have had a severe allergic reaction to thalidomide, lenalidomide, or pomalidomide in the past.My multiple myeloma has worsened after a stem cell transplant.I am pregnant, nursing, breastfeeding, or plan to become pregnant during the study.I haven't had major surgery, plasmapheresis, certain radiation therapies, or systemic myeloma treatments in the last 14 days.I have heart issues like recent heart attack, severe heart failure, or unstable angina.
Research Study Groups:
This trial has the following groups:- Group 1: Iberdomide
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 investigators actively enrolling new participants for the clinical trial?
"According to clinicaltrials.gov, this medical research is presently recruiting participants with the original post date set at April 15th 2022 and most recent update being on April 27th of the same year."
Answered by AI
Has Iberdomide been given the green light by the FDA?
"Our assessment of Iberdomide's safety, based on the Phase 2 trial data available, resulted in a score of two. This is due to limited evidence supporting efficacy and some data indicating its security profile."
Answered by AI
How many individuals are being enlisted in this investigation?
"Affirmative. Details published on clinicaltrials.gov certify that this investigation, initially listed on April 15th 2022, is actively recruiting. 38 people need to be recruited from 1 trial site."
Answered by AI
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