drugset / Trial / NCT04790474

Ixazomib-pomalidomide-dexamethasone as Second or Third-line Combination Treatment for Patients With Relapsed and Refractory Multiple Myeloma Previously Treated With Daratumumab, Lenalidomide and Bortezomib

NCT04790474

Phase 2 Active not recruiting 61 enrolled Tel-Aviv Sourasky Medical Center
NaSingle-groupOpen-labelTreatment

Summary

Adult patients with a confirmed diagnosis of symptomatic and relapsed and/or refractory MM, after receiving bortezomib, lenalidomide and daratumumab during first and second lines, will be eligible to be enrolled in this study. During the first three treatment cycles, patients will be seen twice (Days 1 and 15 of the cycle). Starting from cycle 4 and on, patients will be assessed once per cycle (Day 1), until disease progression, for disease response and progression according to the International Myeloma Working Group (IMWG) criteria. After progression, all patients will be followed for survival; for this purpose, patients will be contacted every 12 weeks until death or termination of the study by the Sponsor. Patients may continue to receive treatment for 24 months or until disease progression (PD) or unacceptable toxicity, the earlier of the three. Dose modifications may be made based on toxicities. Patients who complete study therapy will continue to receive treatment per standard of care.

Timeline

Start
2021-03-25
Primary completion
2026-03-01
Completion
2029-09-01

Drugs

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

Indications