drugset / Trial / NCT02004275

Pomalidomide and Dexamethasone With or Without Ixazomib in Treating Patients With Relapsed Multiple Myeloma

NCT02004275 ↗

RandomizedCrossoverOpen-labelTreatment

Summary

This randomized phase I/II trial studies the side effects and best dose of pomalidomide and ixazomib when given together with dexamethasone and to see how well pomalidomide and dexamethasone with or without ixazomib works in treating patients with multiple myeloma that has come back. Biological therapies, such as pomalidomide and dexamethasone, may stimulate the immune system in different ways and stop cancer cells from growing. Ixazomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether pomalidomide and dexamethasone are more effective with or without ixazomib in treating multiple myeloma.

Timeline

Start
2014-02
Primary completion
2021-12-01
Completion
—

Outcome

Met primary endpoint

paper improvement in progression-free survival (PFS) that favored IXA-POM-DEX and that crossed the predefined boundary of superiority PMID 39058954 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 20 mg Oral
Subject Ixazomib Unknown 4 mg Oral
Subject Pomalidomide Other / unclassified 4 mg Oral

Indications