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Proteasome Inhibitor
Iberdomide + Daratumumab + Carfilzomib + Dexamethasone for Multiple Myeloma (Iber-KDd Trial)
Phase 2
Recruiting
Led By Carl O Landgren, MD, PhD
Research Sponsored by Carl Ola Landgren, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years at the time of signing the informed consent documentation. Age limit of 75 years
Adequate hepatic function with bilirubin < 1.5 x the upper limit of normal (ULN) and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x ULN measured within 4 weeks of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Iber-KDd Trial Summary
This trial will test a new combination of treatments for people with multiple myeloma that may be more effective than current treatments.
Who is the study for?
This trial is for adults under 75 with relapsed/refractory multiple myeloma who've had 1-3 prior treatments, including a lenalidomide regimen. They must have adequate blood counts, liver function, and kidney clearance. Those with certain heart or lung conditions, active infections like HIV or hepatitis B/C, significant neuropathy, or are pregnant can't join.Check my eligibility
What is being tested?
The study tests a new combination therapy called Iber-KDd (iberdomide with carfilzomib, daratumumab & dexamethasone) against standard treatments for multiple myeloma to see if it's more effective and tolerable in shrinking the cancer or preventing its return.See study design
What are the potential side effects?
Possible side effects include allergic reactions to medications used during treatment (like diphenhydramine), increased risk of infection due to immune suppression from drugs like dexamethasone and daratumumab, liver issues from carfilzomib use, and potential blood disorders.
Iber-KDd Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
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My liver tests are within normal limits.
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I have multiple myeloma that got worse after or during my last treatment, and I've had 1-3 prior treatments including one with lenalidomide.
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I can undergo treatments to prevent blood clots.
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My lung function meets the required standards for someone with COPD.
Iber-KDd Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of MRD-negativity: Iber-KDd Combination therapy.
Secondary outcome measures
Best Response: Iber Monotherapy
Best Response: Iber-KDd Combination Therapy
Duration of Response (DOR): Iber-KDd Combination Therapy
+9 moreIber-KDd Trial Design
2Treatment groups
Experimental Treatment
Group I: Iber-KDd Combination TherapyExperimental Treatment7 Interventions
Prior to Iber-KDd combination therapy, participants will receive Acetaminophen, Diphenhydramine and Montelukast therapy per protocol. Participants will receive up to eight (8) 28-day cycles of combination Iberdomide (I), Carfilzomib (K), Daratumumab (D), and Dexamethasone (d) (Iber-KDd) therapy. Participants will receive Iber-KDd combination therapy for approximately 8 months. In the absence of disease progression, participants will continue on to Iber monotherapy. Participants with disease progression will discontinue study therapy but will continue to be followed for up to three (3) years after conclusion of Iber-KDd combination therapy.
Group II: Iber MonotherapyExperimental Treatment1 Intervention
After completion of Iber-KDd combination therapy, and In the absence of disease progression, participants will then receive up to twelve (12) 28-day cycles of Iberdomide (Iber) monotherapy. Participants will receive Iber monotherapy for up to 12 months or until disease progression. Participants will be followed for up to three (3) years after conclusion of Iber monotherapy. Total study participation is up to five (5) years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Montelukast
2008
Completed Phase 4
~15460
Dexamethasone
2007
Completed Phase 4
~2590
Acetaminophen
2017
Completed Phase 4
~2030
Diphenhydramine
2002
Completed Phase 4
~1170
Iberdomide
2021
Completed Phase 1
~60
Carfilzomib
2017
Completed Phase 3
~1310
Daratumumab
2014
Completed Phase 3
~1960
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Who is running the clinical trial?
Carl Ola Landgren, MD, PhDLead Sponsor
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Multiple Myeloma
50 Patients Enrolled for Multiple Myeloma
Bristol-Myers SquibbIndustry Sponsor
2,650 Previous Clinical Trials
4,130,806 Total Patients Enrolled
88 Trials studying Multiple Myeloma
30,503 Patients Enrolled for Multiple Myeloma
Carl O Landgren, MD, PhDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Multiple Myeloma
50 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have HIV, hepatitis B, or hepatitis C.I am using birth control and have had a recent negative pregnancy test.I have not had major surgery in the last 3 weeks.I am between 18 and 75 years old.I have high blood pressure in the lungs.My liver tests are within normal limits.I cannot take certain medications, including antivirals or blood thinners.I have multiple myeloma that got worse after or during my last treatment, and I've had 1-3 prior treatments including one with lenalidomide.I have previously been treated with carfilzomib under certain conditions.I have serious heart problems.I have an active hepatitis B or C infection.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My blood counts meet the required levels for the trial.I have been diagnosed with POEMS syndrome.I am currently on treatment for multiple myeloma, with some exceptions.My condition did not improve after treatment targeting CD38.I have been diagnosed with plasma cell leukemia.I have difficulty making decisions for myself.I can undergo treatments to prevent blood clots.My kidney function, measured by creatinine clearance, is good.I have previously received CD38-directed therapy under certain conditions.My lung function meets the required standards for someone with COPD.I have been diagnosed with amyloidosis.I have been active and mostly self-sufficient in the last month.My GI disease hasn't improved with standard treatments.I have COPD with less than half the normal lung function.My blood pressure or diabetes is not well-managed.I have severe nerve pain.I have been treated with iberdomide before.
Research Study Groups:
This trial has the following groups:- Group 1: Iber-KDd Combination Therapy
- Group 2: Iber Monotherapy
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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