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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 belowSelect...
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:Select...
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
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 moreAwards & 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
Bone Marrow Biopsy
2021
Completed Phase 3
~230
Computed Tomography
2017
Completed Phase 2
~2740
Biospecimen Collection
2004
Completed Phase 3
~2020
Bone Marrow Aspirate
2015
Completed Phase 3
~40
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,920 Previous Clinical Trials
41,016,933 Total Patients Enrolled
594 Trials studying Multiple Myeloma
191,445 Patients Enrolled for Multiple Myeloma
Shaji K KumarPrincipal InvestigatorECOG-ACRIN Cancer Research Group
6 Previous Clinical Trials
1,795 Total Patients Enrolled
6 Trials studying Multiple Myeloma
1,795 Patients Enrolled for Multiple Myeloma
Media Library
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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