Thalidomide and Prednisone Following Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma

Summary

RATIONALE: Thalidomide may stop the growth of multiple myeloma by stopping blood flow to the tumor. Prednisone may be effective in preventing relapse of multiple myeloma. PURPOSE: Randomized phase II trial to compare the effectiveness of two doses of thalidomide combined with prednisone following peripheral stem cell transplantation in treating patients who have multiple myeloma.

Timeline

Start

2000-07-12

Primary completion

2002-05-03

Completion

2008-12-15

Outcome

Mixed primary results

paper The primary end point was reached by 31% of patients on the 200 mg of thalidomide arm and 64% of patients on the 400 mg of thalidomide arm. PMID 15623591 ↗

paper Only the 200 mg of thalidomide arm of this trial met our definition of a tolerable maintenance therapy PMID 15623591 ↗

Publications

• Results Stewart AK, Chen CI, Howson-Jan K, White D, Roy J, Kovacs MJ, Shustik C, Sadura A, Shepherd L, Ding K, Meyer RM, Belch AR. Results of a multicenter randomized phase II trial of thalidomide and prednisone maintenance therapy for multiple myeloma after autologous stem cell transplant. Clin Cancer Res. 2004 Dec 15;10(24):8170-6. doi: 10.1158/1078-0432.CCR-04-1106.
• Results Stewart KA, Chen C, Howson-Jan K, et al.: A randomized phase II dose-finding trial of thalidomide and prednisone as maintenance therapy for myeloma following autologous stem cell transplant. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-1073, 2002.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Thalidomide	Other / unclassified	200 mg	Oral
Subject	Thalidomide	Other / unclassified	400 mg	Oral
Background	Prednisone	Other / unclassified	50 mg	Oral

Indications