Pomalidomide in Combination With High Dose Dexamethasone and Oral Cyclophosphamide

Phase 1/2 Completed 80 enrolled H. Lee Moffitt Cancer Center and Research Institute Celgene Corporation · collab

RandomizedSingle-groupOpen-labelTreatment

Summary

The main purpose of this study is to see whether pomalidomide can help people with myeloma. Researchers also want to find out if pomalidomide is safe and tolerable.

Timeline

Start: 2011-11
Primary completion: 2016-08
Completion: 2016-08

Outcome

Met primary endpoint

paper The ORR was 38.9% (95% confidence interval [CI], 23-54.8%) and 64.7% (95% CI, 48.6-80.8%) for arms B and C, respectively (P = .035). PMID 26932802 ↗

paper The combination of PomCyDex results in a superior ORR and PFS compared with PomDex in patients with lenalidomide refractory multiple myeloma. PMID 26932802 ↗

Publications

Baz RC, Martin TG 3rd, Lin HY, Zhao X, Shain KH, Cho HJ, Wolf JL, Mahindra A, Chari A, Sullivan DM, Nardelli LA, Lau K, Alsina M, Jagannath S. Randomized multicenter phase 2 study of pomalidomide, cyclophosphamide, and dexamethasone in relapsed refractory myeloma. Blood. 2016 May 26;127(21):2561-8. doi: 10.1182/blood-2015-11-682518. Epub 2016 Mar 1.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cyclophosphamide	Other / unclassified	300 mg	Oral
Subject	Cyclophosphamide	Other / unclassified	400 mg	Oral
Subject	Cyclophosphamide	Other / unclassified	500 mg	Oral
Subject	Dexamethasone	Small molecule	20 mg	Oral
Subject	Dexamethasone	Small molecule	40 mg	Oral
Subject	Pomalidomide	Other / unclassified	4 mg	Oral