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Corticosteroid
Iberdomide + Dexamethasone for Smoldering Multiple Myeloma
Phase 2
Recruiting
Led By Nisha S Joseph, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Left ventricular ejection fraction >= 40%
Subject must have intermediate- or high risk smoldering multiple myeloma (SMM) as confirmed by specific factors
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of protocol therapy to disease progression or death from any cause, whichever comes first, assessed at 1 and 2 years
Awards & highlights
Study Summary
This trial is testing the effects of iberdomide when given alone or with dexamethasone as a treatment for patients with intermediate or high-risk smoldering multiple myeloma.
Who is the study for?
This trial is for people with a condition called smoldering multiple myeloma, who haven't had treatment yet. They need to have certain blood and liver function levels, be diagnosed within the last 5 years, and not have other health issues that could affect the trial. Women who can get pregnant must follow strict rules about testing and birth control.Check my eligibility
What is being tested?
The study is looking at how well a drug called Iberdomide works on its own or when combined with Dexamethasone in patients with intermediate or high-risk smoldering multiple myeloma. It's checking if this combo can delay the disease from getting worse while being easier to tolerate.See study design
What are the potential side effects?
Iberdomide may change immune system behavior which might lead to cancer cells growing slower or not at all. Side effects could include those typical of immunotherapies like fatigue, digestive issues, and possible increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart pumps well enough (ejection fraction is 40% or more).
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My condition is intermediate or high risk smoldering multiple myeloma.
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My blood counts and kidney function meet the required levels.
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My liver function tests are within normal limits.
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I am mostly active and can care for myself.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of protocol therapy to death, censoring patients who are alive at last follow-up, assessed at 1 and 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of protocol therapy to death, censoring patients who are alive at last follow-up, assessed at 1 and 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall response rate
Secondary outcome measures
Overall survival
Progression-free survival
Rate of grade 3-4 adverse events
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (iberdomide hydrochloride, dexamethasone)Experimental Treatment3 Interventions
Patients receive iberdomide hydrochloride PO QD on days 1-21 and dexamethasone PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive iberdomide hydrochloride PO QD on days 1-21. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Group II: Arm B (iberdomide hydrochloride)Active Control3 Interventions
Patients receive iberdomide hydrochloride PO QD on days 1-21. Cycles 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
Find a Location
Who is running the clinical trial?
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,841 Total Patients Enrolled
Emory UniversityLead Sponsor
1,648 Previous Clinical Trials
2,568,006 Total Patients Enrolled
9 Trials studying Plasma Cell Myeloma
399 Patients Enrolled for Plasma Cell Myeloma
National Cancer Institute (NCI)NIH
13,728 Previous Clinical Trials
40,965,923 Total Patients Enrolled
65 Trials studying Plasma Cell Myeloma
8,048 Patients Enrolled for Plasma Cell Myeloma
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to follow the study's fertility guidelines.I have another cancer type, but it won't affect this trial's treatment.I use bisphosphonates through IV more than once a year.My heart pumps well enough (ejection fraction is 40% or more).There are specific rules for people with HIV.My condition is intermediate or high risk smoldering multiple myeloma.I agree not to donate blood or reproductive cells during and for 4 weeks after treatment.I was diagnosed with smoldering multiple myeloma less than 5 years ago.My blood counts and kidney function meet the required levels.My liver function tests are within normal limits.I am receiving or have received treatment for a plasma cell disorder.I do not have a stomach or bowel condition that affects how my body absorbs medication.I am following the required pregnancy prevention measures.I am eligible regardless of my gender, race, or ethnicity.I am mostly active and can care for myself.My multiple myeloma needs treatment according to specific criteria.I do not have MGUS, POEMS, plasma cell leukemia, AL amyloidosis, or Waldenstrom's macroglobulinemia.I do not have any uncontrolled illnesses.I haven't taken immunosuppressive drugs in the last 14 days, except for allowed exceptions.You currently have hepatitis B or C that is not being treated.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B (iberdomide hydrochloride)
- Group 2: Arm A (iberdomide hydrochloride, 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.
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