Ixazomib + Lenalidomide for Multiple Myeloma

Recruiting at 255 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: National Cancer Institute (NCI)

Must be taking: Lenalidomide

Must not be taking: Strong CYP3A inducers

Disqualifiers: Uncontrolled illness, Other malignancy, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Trial Summary

What is the purpose of this trial?

This phase III trial studies how well lenalidomide in combination with ixazomib works compared to lenalidomide alone in treating patients with evidence of residual multiple myeloma after stem cell transplantation. Lenalidomide may help shrink or slow the growth of multiple myeloma. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving lenalidomide and ixazomib together may work better than giving lenalidomide alone in treating patients with evidence of residual multiple myeloma after a stem cell transplantation.

Research Team

Shaji K Kumar

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

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.

Inclusion Criteria

I have been on lenalidomide for 6-18 months after early stem cell transplant for my multiple myeloma.

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

Your total bilirubin levels must be within a certain range, as tested within two weeks before the start of the study.

Exclusion Criteria

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

I am not currently on any experimental treatments or chemotherapy.

I am taking bisphosphonates for bone health while on this treatment.

Treatment Details

Interventions

• Ixazomib Citrate
• Lenalidomide

Trial Overview 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.

Participant Groups

Group I: Arm A (lenalidomide, ixazomib citrate) Experimental Treatment 8 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 Group 9 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.

Ixazomib Citrate is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Ninlaro for:

• Multiple myeloma

Approved in United States as Ninlaro for:

• Multiple myeloma

Approved in Canada as Ninlaro for:

• Multiple myeloma

Approved in Japan as Ninlaro for:

• Multiple myeloma

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+