MTD, Safety, and Efficacy of Pomalidomide (CC-4047) Alone or With Low-dose Dexamethasone in Patients With Relapsed and Refractory Multiple Myeloma

Summary

The purpose of this study is to determine the maximum tolerated dose and effectiveness of the study drug (CC-4047) Alone Or in Combination With Low-dose Dexamethasone as treatment for patients with relapsed and refractory multiple myeloma

Timeline

Start

2008-06

Primary completion

2011-04

Completion

2015-09

Outcome

Met primary endpoint

registry Phase 2: Pomalidomide + Dexamethasone vs Phase 2: Pomalidomide; Cox Proportional Hazard 0.73 (95% CI 0.54 to 0.99) NCT00833833 ↗

paper median PFS was 4.2 and 2.7 months (hazard ratio = 0.68, P = .003) PMID 24421329 ↗

Publications

• Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. doi: 10.1080/10428194.2016.1177181. Epub 2016 Jun 7.
• Richardson PG, Siegel DS, Vij R, Hofmeister CC, Baz R, Jagannath S, Chen C, Lonial S, Jakubowiak A, Bahlis N, Song K, Belch A, Raje N, Shustik C, Lentzsch S, Lacy M, Mikhael J, Matous J, Vesole D, Chen M, Zaki MH, Jacques C, Yu Z, Anderson KC. Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study. Blood. 2014 Mar 20;123(12):1826-32. doi: 10.1182/blood-2013-11-538835. Epub 2014 Jan 13.
• Richardson PG, Siegel D, Baz R, Kelley SL, Munshi NC, Laubach J, Sullivan D, Alsina M, Schlossman R, Ghobrial IM, Doss D, Loughney N, McBride L, Bilotti E, Anand P, Nardelli L, Wear S, Larkins G, Chen M, Zaki MH, Jacques C, Anderson KC. Phase 1 study of pomalidomide MTD, safety, and efficacy in patients with refractory multiple myeloma who have received lenalidomide and bortezomib. Blood. 2013 Mar 14;121(11):1961-7. doi: 10.1182/blood-2012-08-450742. Epub 2012 Dec 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dexamethasone	Small molecule	20 mg	Oral
Subject	Dexamethasone	Small molecule	40 mg	Oral
Subject	Pomalidomide	Other / unclassified	2 mg	Oral
Subject	Pomalidomide	Other / unclassified	3 mg	Oral
Subject	Pomalidomide	Other / unclassified	4 mg	Oral
Subject	Pomalidomide	Other / unclassified	5 mg	Oral
Background	Aspirin	Small molecule	81 mg	—
Background	Aspirin	Small molecule	100 mg	—

Indications