Ixazomib for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byShaji K. Kumar, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Mayo Clinic

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase II trial studies how well ixazomib citrate works in treating patients with multiple myeloma that has returned after a period of improvement (relapsed) but is not resistant to bortezomib (refractory). Ixazomib citrate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

This trial is for patients with relapsed multiple myeloma who are not resistant to bortezomib. They should have recovered from previous treatments, have adequate organ function, and no severe concurrent illnesses. Those with certain infections or a recent history of other cancers (except nonmelanoma skin cancer) are excluded.

Inclusion Criteria

Willing to return to consenting Mayo Clinic institution for follow-up during the Active Monitoring Phase of the study; Note: during the Active Monitoring Phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up

I have recovered from side effects of my previous cancer treatment.

My kidney function, measured by creatinine clearance, is adequate.

+12 more

Exclusion Criteria

You have hepatitis B or active hepatitis C infection.

I am HIV positive.

This criterion refers to a list of specific conditions or factors that will be mentioned in the following text.

+15 more

Participant Groups

The study tests ixazomib citrate's effectiveness in treating relapsed multiple myeloma when it's not refractory to bortezomib. It includes dexamethasone, cyclophosphamide, daratumumab, and lab biomarker analysis to see if the drug can halt cancer cell growth by blocking key enzymes.

5Treatment groups

Experimental Treatment

Group I: Arm E (ixazomib citrate, cyclophosphamide, daratumumab)Experimental Treatment5 Interventions

Patients receive ixazomib citrate PO on days 1, 8, and 15, cyclophosphamide PO (cycles 1-12 only) on days 1, 8, 15, 22, and daratumumab IV on days 1, 8, 15, 22 (cycles 1-2), days 1 and 15 (cycles 3-6), and day 1 in all subsequent cycles. Patients also receive dexamethasone IV or PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group II: Arm D (ixazomib citrate, dexamethasone, and cyclophosphamide)Experimental Treatment4 Interventions

Patients receive ixazomib citrate PO on days 1, 8, and 15 and cyclophosphamide PO (cycles 1-18 only) and dexamethasone PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group III: Arm C (higher-dose ixazomib citrate and dexamethasone)Experimental Treatment3 Interventions

Patients receive higher doses of ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group IV: Arm B (ixazomib citrate and dexamethasone)Experimental Treatment3 Interventions

Patients receive ixazomib citrate PO on days 1, 8, and 15 and dexamethasone PO on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Group V: Arm A (ixazomib citrate and dexamethasone, closed to accrual)Experimental Treatment3 Interventions

Patients receive ixazomib citrate PO on days 1, 8, and 15. Patients with lack of minor response by the end of the second cycle or lack of partial response by the end of the fourth cycle also receive dexamethasone PO on days 1, 2, 8, 9, 15, and 16. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

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

🇪🇺 Approved in European Union as Ninlaro for: