Japanese Phase 2 Study to Evaluate the Efficacy and Safety of Pomalidomide in Subjects With Relapsed and Refractory Multiple Myeloma

NCT02011113 ↗

Phase 2 Completed 36 enrolled Celgene Corporation

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of pomalidomide in combination with dexamethasone in subjects with relapsed and refractory multiple myeloma.

Timeline

Start: 2013-12
Primary completion: 2014-09
Completion: 2015-09

Outcome

Met primary endpoint

registry NUMBER Pomalidomide Plus Dexamethasone: 25.0 (10.855 to 39.145) percentage of participants responding NCT02011113 ↗

registry Pomalidomide Plus Dexamethasone; p = 0.0027; Binomial test for dichotomized response NCT02011113 ↗

Publications

Ichinohe T, Kuroda Y, Okamoto S, Matsue K, Iida S, Sunami K, Komeno T, Suzuki K, Ando K, Taniwaki M, Tobinai K, Chou T, Kaneko H, Iwasaki H, Uemura C, Tamakoshi H, Zaki MH, Doerr T, Hagiwara S. A multicenter phase 2 study of pomalidomide plus dexamethasone in patients with relapsed and refractory multiple myeloma: the Japanese MM-011 trial. Exp Hematol Oncol. 2016 Apr 18;5:11. doi: 10.1186/s40164-016-0040-7. eCollection 2015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	20 mg	Oral
Subject	Dexamethasone	Small molecule	40 mg	Oral
Subject	Pomalidomide	Other / unclassified	4 mg	Oral