Ixazomib and Pevonedistat in Treating Patients With Multiple Myeloma That Has Come Back or Does Not Respond to Treatment

Recruiting in Palo Alto (17 mi)

+8 other locations

Overseen byNisha Joseph

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase Ib trial studies side effects and best dose of pevonedistat when given together with ixazomib in treating patients with multiple myeloma that has come back or does not respond to treatment. Pevonedistat and ixazomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Eligibility Criteria

Inclusion Criteria

AST/ALT =< 3.0 x institutional ULN

Creatinine clearance (CrCl) by Cockcroft-Gault >= 30 mL/min

You have already tried and failed at least two different treatments.

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Exclusion Criteria

You cannot participate in the study if you are currently taking any experimental medications.

You have severe lung artery disease that needs medication to treat.

Prolonged QTc interval >= 500 msec

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Treatment Details

Interventions

Ixazomib Citrate (Proteasome Inhibitor)
Pevonedistat (NEDD8-activating enzyme inhibitor)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (ixazomib citrate, pevonedistat)Experimental Treatment2 Interventions

Patients receive ixazomib citrate PO QD on days 1, 8, and 15 of each cycle and pevonedistat IV over 60 minutes on days 1, 8, and 15 of each cycle. 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: