Originally published as JCO Early Release 10.1200/JCO.2008.19.9240 on June 22 2009

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Phase II Study of Thalidomide Plus Dexamethasone Induction Followed by Tandem Melphalan-Based Autotransplantation and Thalidomide-Plus-Prednisone Maintenance for Untreated Multiple Myeloma: A Southwest Oncology Group Trial (S0204)

From the H. Lee Moffitt Cancer and Research Center, Tampa, FL; Southwest Oncology Group Biostatistical Center, Seattle, WA; Wayne State University Karmanos Cancer Institute, Detroit; and University of Michigan Medical Center, Ann Arbor, MI; Cedars-Sinai Comprehensive Cancer Center, Los Angeles, CA; and University of Arkansas for Medical Sciences, Little Rock, AR.

Corresponding author: Bart Barlogie, MD, PhD, Myeloma Institute for Research and Therapy, University of Arkansas for Medical Sciences, 4301 W Markham St, #816, Little Rock, AR 72205; e-mail: barlogiebart{at}uams.edu.

Purpose Thalidomide-dexamethasone (THAL-DEX) is standard induction therapy for multiple myeloma (MM). Tandem melphalan-based transplantations have yielded superior results to single transplantations. Phase II trial S0204 was designed to improve survival results reported for the predecessor, phase III trial S9321 by 50%.

Patients and Methods Newly diagnosed patients with MM were eligible for S0204 with THAL-DEX induction, tandem melphalan-based tandem transplantation, and THAL-prednisone maintenance.

Results Of 143 eligible patients, 142 started induction, 73% completed first transplantation, 58% completed second transplantation, and 56% started maintenance. The quantity of stem cells required for two transplantations was reached in 88% of 111 patients undergoing collection, 74% of whom completed both transplantations. Partial response, very good partial remission, and complete response were documented after 12 months of maintenance therapy in 87%, 72%, and 22% of patients, respectively. During a median follow-up time of 37 months, 4-year estimates of event-free and overall survival were 50% and 64%, respectively. Survival outcomes were superior for International Staging System (ISS) stage 1 disease, when lactate dehydrogenase (LDH) levels were normal and a second transplantation was applied in a timely fashion.

Conclusion Both overall survival (P = .0002) and event-free survival (P < .0001) were significantly improved with S0204 compared with S9321 when 121 and 363 patients, respectively, were matched on ISS stage and LDH.

Supported in part by PHS Cooperative Agreement Grants No. CA-32102, CA-38926, CA37981, CA14028, CA27057, CA04919, CA11083, CA45377, CA35261, CA67575, CA35090, CA63844, CA35431, CA67663, CA46282, CA22433, CA35119, CA46441, CA45450, CA76447, CA35176, CA46113, CA12644, CA58861, CA35178, and CA20319, awarded by the National Cancer Institute, Department of Health and Human Services.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical Trials repository link available on JCO.org.

Clinical trial information can be found for the following: NCT00040937.

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