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Proteasome Inhibitor
Quadruple Therapy for Multiple Myeloma
Phase 1 & 2
Recruiting
Led By Prashant Kapoor
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1 or 2
Age >= 18 years at the time of signing the informed consent form (ICF)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
Study Summary
This trial is testing a new combination therapy for newly diagnosed multiple myeloma, to see if it is more effective than current treatments and has fewer side effects.
Who is the study for?
Adults with newly diagnosed multiple myeloma who haven't been treated or have had only one treatment cycle. They must have measurable disease, be in good physical condition, and have proper organ function. Pregnant or breastfeeding individuals can't join, nor can those unwilling to use contraception or those with certain medical conditions that could interfere with the trial.Check my eligibility
What is being tested?
The IDEAL study is testing a combination of drugs: Iberdomide (an immunotherapy), Daratumumab (a monoclonal antibody), Bortezomib (blocks enzymes for cell growth), and Dexamethasone (chemotherapy). The goal is to find the best dose of Iberdomide and see how well these drugs work together against multiple myeloma.See study design
What are the potential side effects?
Possible side effects include immune system changes leading to inflammation in various organs, infusion reactions from antibodies, fatigue from chemotherapy, potential blood disorders due to enzyme inhibition by Bortezomib, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am able to care for myself and perform daily activities.
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I am 18 years old or older.
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I have measurable cancer lesions outside of my bone marrow.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Complete response rate (Phase II)
Maximum tolerated dose (MTD) of iberdomide (Phase I)
Secondary outcome measures
Incidence of adverse events (AEs) (Phase II)
Overall response rate (Phase II)
Overall survival (Phase II)
+3 moreOther outcome measures
Minimal residual disease
Proportion of patients who achieve sustained MRD negative status
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (iberdomide, bortezomib, dexamethasone, daratumumab)Experimental Treatment4 Interventions
INDUCTION PHASE: Patients receive iberdomide PO QD on days 1-21, bortezomib SC on days, 1, 8, 15, and 22, and dexamethasone PO on days 1, 8, 15, 22. Patients also receive daratumumab SC on days 1, 8, 15, 22 of cycles 1 and 2, days 1 and 15 of cycles 3-6, and day 1 of subsequent cycles. Treatment repeats every 28 days for 12 cycles in the absence of disease progression or unacceptable toxicity.
CYCLES 13-36 CYCLES: Patients receive iberdomide PO QD on days 1-21. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bortezomib
FDA approved
CC-220
Not yet FDA approved
Daratumumab
FDA approved
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,663 Previous Clinical Trials
40,925,887 Total Patients Enrolled
579 Trials studying Multiple Myeloma
189,113 Patients Enrolled for Multiple Myeloma
Mayo ClinicLead Sponsor
3,209 Previous Clinical Trials
3,767,116 Total Patients Enrolled
76 Trials studying Multiple Myeloma
9,693 Patients Enrolled for Multiple Myeloma
Prashant KapoorPrincipal InvestigatorMayo Clinic in Rochester
2 Previous Clinical Trials
89 Total Patients Enrolled
2 Trials studying Multiple Myeloma
89 Patients Enrolled for Multiple Myeloma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have no allergies to study drugs, haven't had major surgery, plasmapheresis, or investigational treatments recently.I agree not to donate blood during the study.I haven't had live vaccines recently and have no cancer history except MM, with some exceptions.I am HIV positive or have active hepatitis B or C.I have had radiation therapy for a single plasmacytoma.I am able to care for myself and perform daily activities.I do not have severe nerve damage, very high calcium levels, gut diseases affecting drug absorption, or severe allergies to certain drugs.My IgA myeloma can't be measured accurately by blood tests.I have a blood disorder but it's not active cancer.I am 18 years old or older.I have multiple myeloma and have had little to no treatment for it.I have measurable cancer lesions outside of my bone marrow.I do not have any uncontrolled illnesses that could affect my trial participation.I have undergone more than one treatment cycle for my multiple myeloma.I am not pregnant, not nursing, and willing to use contraception if of childbearing potential.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (iberdomide, bortezomib, dexamethasone, daratumumab)
Awards:
This trial has 2 awards, including:- 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.
How many people are eligible for this program?
"That is correct. The listings on clinicaltrials.gov say that this particular study is looking for patients right now. This trial was originally posted on August 11th, 2020 and was updated recently on the 12th of August. They need a total of 18 individuals from 1 location."
Answered by AI
Are there any vacancies for this research project?
"Yes, based on the information available from clinicaltrials.gov, this trial is currently looking for subjects to participate. The trial was originally posted on 8/11/2022 and has had one update since then on 8/12/2022. They are recruiting 18 patients from 1 location."
Answered by AI
What is the purpose of this clinical trial?
"The primary objective of this clinical trial is to assess the complete response rate over a period of up to 12 cycles (each cycle being 28 days). Secondary objectives include estimating the overall response rate and progression-free survival, which will be done using the Kaplan-Meier method."
Answered by AI
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