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Corticosteroid

IRD Regimen for Multiple Myeloma

Phase 2

Waitlist Available

Led By Ravi Vij, M.D.

Research Sponsored by Washington University School of Medicine

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 and/or other performance status 0, 1, or 2

Women of childbearing potential must follow pregnancy testing requirements as outlined in the Revlimid REMS program material. This is defined as either committing to continued abstinence from heterosexual intercourse or beginning TWO acceptable methods of contraception (one highly effective method and one additional effective method AT THE SAME TIME) at least 28 days prior to the start of lenalidomide, for the duration of study participation, and for 28 days following the last dose of lenalidomide. Women of childbearing potential must also agree to ongoing pregnancy testing

Must not have

Female patients who are lactating or have a positive serum pregnancy test during the screening period

Tandem autologous transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days after the completion of maintenance treatment (estimated to be day 1125 of maintenance treatment)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for people who have had stem cell transplants, to see if it can help prolong the time they are disease-free.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include low blood counts leading to increased infection risk; nerve damage causing pain or numbness; digestive issues like nausea and diarrhea; rash; fatigue; liver problems indicated by abnormal tests; and potential blood clots due to lenalidomide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can take care of myself and perform daily activities.

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I am following strict birth control and pregnancy testing as required if I can have children.

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I am between 18 and 70 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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

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I do not have severe heart issues or uncontrolled blood pressure problems.

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I have an active hepatitis infection or am HIV positive.

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I do not have any stomach or intestine problems that could affect how a medicine is absorbed.

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I have had plasma cell leukemia or myeloma that spread to the brain.

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I have severe nerve damage in my hands or feet, or moderate with pain.

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I have not had major surgery in the last 2 weeks.

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I am not receiving treatment for any cancer other than multiple myeloma or secondary amyloidosis.

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I have had an organ transplant and am on immunosuppressive drugs.

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I have not needed antibiotics for a serious infection in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days after the completion of maintenance treatment (estimated to be day 1125 of maintenance treatment)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days after the completion of maintenance treatment (estimated to be day 1125 of maintenance treatment)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days after the completion of maintenance treatment (estimated to be day 1125 of maintenance treatment) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Improvement in Minimal Residual Disease (MRD)

Secondary study objectives

Association of Overall Survival With MRD-negativity

Association of Overall Survival With MRD-positivity

Association of Progression-free Survival With MRD-negativity

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixazomib

2017

Completed Phase 4

~3510

Lenalidomide

2005

Completed Phase 3

~2240