IRD Regimen for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byRavi Vij, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

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

Your blood and organ function should be within specific ranges, and you should not have received platelet transfusions within 7 days before the study.

I agree to follow the study's rules about preventing pregnancy.

I have been diagnosed with symptomatic multiple myeloma.

+6 more

Exclusion Criteria

I am not pregnant or breastfeeding.

I am scheduled for or have had two stem cell transplants using my own cells.

I am not planning to receive any other cancer treatments until 28 days after my transplant.

+13 more

Participant Groups

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:

🇪🇺 Approved in European Union as Dexamethasone for: