A clinical study of Ibrutinib taken together with Pomalidomide and Dexamethasone in patients with Multiple Myeloma (who have stopped responding or have failed to respond to current treatments)

Registry ID
EUCTR2015-002191-25
Source registry
EUCTR
Status
Completed
Phase
PHASE2
Sponsor
Pharmacyclics LLC
Start date
2016-03-31
Completion date
2018-06-13
Last update
2026-08-16

Conditions

Summary

Phase 1: -To determine the maximum tolerate dose (MTD)/maximum administered dose (MAD) and the Phase 2b dose of the ibrutinib, pomalidomide and dexamethasone combination. - To determine the safety and tolerability of ibrutinib in combination with pomalidomide and dexamethasone in subjects with relapsed/refractory Multiple Myeloma (MM). Phase 2b: - To evaluate the effect of ibrutinib in combination with pomalidomide and dexamethasone compared to placebo in combination with pomalidomide and dexamethasone on progression-free survival (PFS), as assessed by independent review committee (IRC), in subjects with relapsed/refractory MM.

Locations

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