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Proteasome Inhibitor

Ixazomib + Lenalidomide for Multiple Myeloma

Phase 3

Waitlist Available

Led By Shaji K Kumar

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have been able to maintain at least 5mg daily dose of lenalidomide without growth factor support

Patient must be >= 18 years of age

Must not have

Patients must not have known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of ixazomib or lenalidomide including difficulty swallowing

Patient must not be on other concurrent chemotherapy, or any ancillary therapy considered investigational

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at baseline, end of every 3 cycles for the first 24 cycles, every 6 cycles thereafter up to completion of 48 cycles, and at treatment discontinuation prior to completing 48 cycles. during long-term follow-up, 4 quarterly assessments for 1 year.

Awards & highlights

Pivotal Trial

Summary

This trial compares lenalidomide alone to lenalidomide + ixazomib in treating patients with residual multiple myeloma after stem cell transplant.

Who is the study for?

Adults over 18 with multiple myeloma who have had a stem cell transplant within the last year and are on lenalidomide maintenance can join. They must show signs of residual cancer, be HIV-positive with undetectable viral load if applicable, and not have been off lenalidomide for more than 30 days. Participants need proper organ function, no severe illnesses or psychiatric conditions that could affect participation, and agree to birth control measures.

What is being tested?

The OPTIMUM trial is testing whether adding Ixazomib (or a placebo) to Lenalidomide treatment is more effective in patients with remaining signs of multiple myeloma after stem cell transplantation. The study involves bone marrow biopsies, imaging tests like CT and PET scans, blood tests, quality-of-life assessments through questionnaires, and biospecimen collection.

What are the potential side effects?

Possible side effects include digestive issues that may affect absorption or tolerance of the drugs; nerve problems such as peripheral neuropathy; blood disorders affecting hemoglobin levels or platelet counts; liver function changes; fatigue; risk of infection due to immune system impact.

Eligibility Criteria

Inclusion Criteria

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

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I have been taking a daily dose of 5mg lenalidomide without needing additional medication to support my blood cell levels.

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I am 18 years old or older.

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I can take care of myself and am up and about more than half of my waking hours.

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My tests show remaining cancer cells or protein indicating cancer.

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I can have a bone marrow test after signing up.

Exclusion Criteria

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

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I don't have GI issues that affect my ability to take pills.

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I am not currently on any experimental treatments or chemotherapy.

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I do not have moderate to severe diarrhea without taking medication.

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My disease did not worsen while on a proteasome inhibitor regimen before my stem cell transplant.

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I do not have severe numbness, tingling, or pain in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 10 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Overall Survival (OS)

Secondary study objectives

Best Response on Treatment

Progression-free Survival (PFS)

Other study objectives

Adherence Starts With Knowledge (ASK)-12 Scores

Cumulative Dose

Dose Intensity

+14 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm A (lenalidomide, ixazomib citrate)Experimental Treatment8 Interventions

Patients receive lenalidomide PO QD on days 1-28 and ixazomib citrate PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and/or biopsy and PET and CT scan at screening and on study as well as undergo collection of blood samples throughout the trial.

Group II: Arm B (lenalidomide, placebo)Placebo Group9 Interventions

Patients receive lenalidomide PO QD on days 1-28 and a placebo PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo bone marrow aspirate and/or biopsy and PET and CT scan at screening and on study as well as undergo collection of blood samples throughout the trial.

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