Trial Summary
What is the purpose of this trial?The purpose of this research study is to evaluate a treatment regimen called IRD which will be given to participants after their stem cell transplant in an effort to help prolong the amount of time the participants are disease-free after transplant. IRD is a three-drug regimen consisting of ixazomib, lenalidomide (also called Revlimid), and dexamethasone. After 4 cycles of IRD, the participants will be randomized to receive maintenance therapy either with ixazomib or lenalidomide.
Eligibility Criteria
Adults aged 18-70 with symptomatic multiple myeloma, who've had initial therapy and are within 2-16 months of starting it. They must have good organ function, not be pregnant or breastfeeding, agree to contraception if applicable, and follow REMS program requirements for lenalidomide. Exclusions include other active cancers needing treatment, recent major surgery or serious infections, certain heart conditions, severe neuropathy among others.Inclusion Criteria
I can take care of myself and perform daily activities.
I am following strict birth control and pregnancy testing as required if I can have children.
I am between 18 and 70 years old.
Exclusion Criteria
I am not pregnant or breastfeeding.
I am scheduled for or have had two stem cell transplants using my own cells.
I do not have severe heart issues or uncontrolled blood pressure problems.
I have an active hepatitis infection or am HIV positive.
I do not have any stomach or intestine problems that could affect how a medicine is absorbed.
I have had plasma cell leukemia or myeloma that spread to the brain.
I have severe nerve damage in my hands or feet, or moderate with pain.
I have not had major surgery in the last 2 weeks.
I am not receiving treatment for any cancer other than multiple myeloma or secondary amyloidosis.
I have had an organ transplant and am on immunosuppressive drugs.
I have not needed antibiotics for a serious infection in the last 2 weeks.
Treatment Details
The trial is testing the IRD regimen (Ixazomib, Lenalidomide, Dexamethasone) after stem cell transplantation in multiple myeloma patients. Post four cycles of IRD treatment participants will randomly receive maintenance therapy with either Ixazomib or Lenalidomide to see which helps keep the disease at bay longer.
3Treatment groups
Experimental Treatment
Group I: Maintenance Arm 2: LenalidomideExperimental Treatment1 Intervention
Lenalidomide will be administered daily continuously for a 28-day cycle at a starting dose of 10 mg. If lenalidomide is tolerated well (i.e. no dose modification required) during the first three cycles, lenalidomide dose will be increased to 15 mg daily and will continue until patient progresses or experiences an unacceptable toxicity.
Group II: Maintenance Arm 1: IxazomibExperimental Treatment1 Intervention
Ixazomib will be administered on Days 1, 8, and 15 of a 28-day cycle at a starting dose of 4 mg until patient progresses or experiences an unacceptable toxicity.
Group III: Consolidation: Ixazomib, Lenalidomide, & DexamethasoneExperimental Treatment3 Interventions
Consolidation therapy will begin between Day 80 and Day 120 following ASCT and will consist of four 28-day cycles of IRD (ixazomib, lenalidomide, \& dexamethasone). Barring dose modifications for toxicity, 4 mg of ixazomib and 40 mg of dexamethasone will be administered on Days 1, 8, and 15, and 15 mg of lenalidomide will be administered on daily on Days 1-21.
Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:
πͺπΊ Approved in European Union as Dexamethasone for:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
- Immune system disorders
πΊπΈ Approved in United States as Dexamethasone for:
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
- Neoplastic diseases
- Nervous system disorders
π¨π¦ Approved in Canada as Dexamethasone for:
- Inflammation
- Allergic reactions
- Respiratory diseases
- Skin conditions
- Eye diseases
π―π΅ Approved in Japan as Dexamethasone for:
- Inflammatory conditions
- Allergic states
- Respiratory diseases
- Blood disorders
Find a clinic near you
Research locations nearbySelect from list below to view details:
Mayo ClinicRochester, MN
Washington University School of MedicineSaint Louis, MO
Ohio State University Comprehensive Cancer CenterColumbus, OH
Tennessee Oncology, PLLCNashville, TN
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
Millennium Pharmaceuticals, Inc.Industry Sponsor
Multiple Myeloma Research ConsortiumCollaborator