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Ixazomib + Lenalidomide Maintenance Therapy for Multiple Myeloma

Phase 2

Waitlist Available

Led By Leona Holmberg

Research Sponsored by Fred Hutchinson Cancer Research Center

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

Calculated creatinine clearance >= 30 mL/min

Must not have

Systemic treatment, within 14 days before the first dose of ixazomib, with strong inhibitors of cytochrome P450, family 1, subfamily A, polypeptide 2 gene (CYP1A2) (fluvoxamine, enoxacin, ciprofloxacin), strong inhibitors of cytochrome P450, family 3, subfamily A gene locus (CYP3A) (clarithromycin, telithromycin, itraconazole, voriconazole, ketoconazole, nefazodone, posaconazole) or strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort

Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up median 4.6 years from start of therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if ixazomib citrate & lenalidomide, given as maintenance therapy after stem cell transplant, can prolong the time until cancer returns.

Who is the study for?

This trial is for multiple myeloma patients who've had a stem cell transplant using high dose melphalan therapy. They should be within 30-120 days post-transplant, recovered from acute toxicity, and have an ECOG performance status of 0-2. Participants must not be pregnant or breastfeeding, agree to contraception if of childbearing potential, and have adequate organ function. Exclusions include active infections, recent major surgery or radiotherapy, uncontrolled heart conditions, known allergies to study drugs or their components (including boron), certain prior cancers within 2 years except nonmelanoma skin cancer with complete resection.

What is being tested?

The phase II trial tests alternating ixazomib citrate with lenalidomide as maintenance therapy after stem cell transplant in multiple myeloma patients. Ixazomib may block enzymes needed for cancer growth while lenalidomide might stimulate the immune system against cancer cells. The goal is to extend the time before the cancer returns.

What are the potential side effects?

Potential side effects can include digestive issues that affect oral drug absorption or tolerance; allergic reactions including those to boron; peripheral neuropathy (nerve damage) which could cause pain; and possible interactions with other medications affecting liver enzymes like CYP1A2 and CYP3A.

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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My kidneys are functioning well enough to clear waste.

Exclusion Criteria

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

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I haven't taken specific strong medications or herbal supplements in the last 14 days.

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I do not have an active infection, hepatitis B or C, or HIV.

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I have a stomach or intestine condition that affects my ability to take pills.

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

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I do not have any uncontrolled heart conditions.

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I have not had major surgery in the last 14 days.

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My condition worsened on lenalidomide before my transplant.

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My multiple myeloma has affected my brain or spinal cord.

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I am not pregnant or breastfeeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ median 4.6 years from start of therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~median 4.6 years from start of therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and median 4.6 years from start of therapy 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 Adverse Events, Graded According to CTCAE Version 4.0

Secondary study objectives

Overall Survival

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (ixazomib citrate and lenalidomide)Experimental Treatment3 Interventions

Within 30-120 days after finishing autologous transplant, patients receive ixazomib citrate PO on days 1, 8 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients then receive lenalidomide PO QD on days 1-28. Treatment repeats for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients will continue to alternate between ixazomib citrate and lenalidomide every 2 courses for up to 24 months in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ixazomib Citrate

2012

Completed Phase 3

~970

Lenalidomide

2005

Completed Phase 3

~2240