Originally published as JCO Early Release 10.1200/JCO.2005.03.0221 on December 19 2005
Journal of Clinical Oncology, Vol 24, No 3 (January 20), 2006: pp. 431-436
© 2006 American Society of Clinical Oncology.
Phase III Clinical Trial of Thalidomide Plus Dexamethasone Compared With Dexamethasone Alone in Newly Diagnosed Multiple Myeloma: A Clinical Trial Coordinated by the Eastern Cooperative Oncology Group
S. Vincent Rajkumar,
Emily Blood,
David Vesole,
Rafael Fonseca,
Philip R. Greipp
From the Division of Hematology, Mayo Clinic, Rochester, MN; Eastern Cooperative Oncology Group Statistical Center, Dana-Farber Cancer Institute, Boston, MA; the Medical College of Wisconsin, Milwaukee, WI; and Mayo Clinic, Scottsdale, AZ
Address reprint requests to S. Vincent Rajkumar, MD, Division of Hematology, Mayo Clinic, 200 First St SW, Rochester, MN 55905; e-mail: rajks{at}mayo.edu
Purpose To determine if thalidomide plus dexamethasone yields superior response rates compared with dexamethasone alone as induction therapy for newly diagnosed multiple myeloma.
Patients and Methods Patients were randomly assigned to receive thalidomide plus dexamethasone or dexamethasone alone. Patients in arm A received thalidomide 200 mg orally for 4 weeks; dexamethasone was administered at a dose of 40 mg orally on days 1 to 4, 9 to 12, and 17 to 20. Cycles were repeated every 4 weeks. Patients in arm B received dexamethasone alone at the same schedule as in arm A.
Results Two hundred seven patients were enrolled: 103 were randomly assigned to thalidomide plus dexamethasone and 104 were randomly assigned to dexamethasone alone; eight patients were ineligible. The response rate with thalidomide plus dexamethasone was significantly higher than with dexamethasone alone (63% v 41%, respectively; P = .0017). The response rate allowing for use of serum monoclonal protein levels when a measurable urine monoclonal protein was unavailable at follow-up was 72% v 50%, respectively. The incidence rates of grade 3 or higher deep vein thrombosis (DVT), rash, bradycardia, neuropathy, and any grade 4 to 5 toxicity in the first 4 months were significantly higher with thalidomide plus dexamethasone compared with dexamethasone alone (45% v 21%, respectively; P < .001). DVT was more frequent in arm A than in arm B (17% v 3%); grade 3 or higher peripheral neuropathy was also more frequent (7% v 4%, respectively).
Conclusion Thalidomide plus dexamethasone demonstrates significantly superior response rates in newly diagnosed myeloma compared with dexamethasone alone. However, this must be balanced against the greater toxicity seen with the combination.
Supported by the Eastern Cooperative Oncology Group (Robert L. Comis, MD, Chair) and supported in part by Public Health Service Grants No. CA23318, CA66636, CA21115, CA13650, and CA93842 from the National Cancer Institute, National Institutes of Health and the Department of Health and Human Services. Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.
Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.
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J.-L. Harousseau, S. Jagannath, P. G. Richardson, P. Sonneveld, M. W. Schuster, D.-L. Esseltine, and K. C. Anderson
Bortezomib in Combination with High-Dose Dexamethasone (HD dex) and Erythropoietin (EPO) Does Not Result in an Increased Risk of Thromboembolic Complications.
Blood (ASH Annual Meeting Abstracts),
November 16, 2006;
108(11):
3543 - 3543.
[Abstract]
[PDF]
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P. G. Richardson, E. Blood, C. S. Mitsiades, S. Jagannath, S. R. Zeldenrust, M. Alsina, R. L. Schlossman, S. V. Rajkumar, K. R. Desikan, T. Hideshima, et al.
A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma
Blood,
November 15, 2006;
108(10):
3458 - 3464.
[Abstract]
[Full Text]
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S. Singhal and J. Mehta
Multiple Myeloma
Clin. J. Am. Soc. Nephrol.,
November 1, 2006;
1(6):
1322 - 1330.
[Abstract]
[Full Text]
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M. Offidani, L. Corvatta, M.-N. Piersantelli, G. Visani, F. Alesiani, M. Brunori, P. Galieni, M. Catarini, M. Burattini, R. Centurioni, et al.
Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma
Blood,
October 1, 2006;
108(7):
2159 - 2164.
[Abstract]
[Full Text]
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L. Mileshkin, R. Stark, B. Day, J. F. Seymour, J. B. Zeldis, and H. M. Prince
Development of Neuropathy in Patients With Myeloma Treated With Thalidomide: Patterns of Occurrence and the Role of Electrophysiologic Monitoring
J. Clin. Oncol.,
September 20, 2006;
24(27):
4507 - 4514.
[Abstract]
[Full Text]
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M. Q. Lacy, A. Dispenzieri, M. A. Gertz, P. R. Greipp, K. L. Gollbach, S. R. Hayman, S. Kumar, J. A. Lust, S. V. Rajkumar, S. J. Russell, et al.
Mayo Clinic Consensus Statement for the Use of Bisphosphonates in Multiple Myeloma
Mayo Clin. Proc.,
August 1, 2006;
81(8):
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[Abstract]
[Full Text]
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M. Q. Lacy
Multiple Myeloma: New Options, New Challenges
Mayo Clin. Proc.,
July 1, 2006;
81(7):
877 - 879.
[Full Text]
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J. A. Zonder, B. Barlogie, B. G. M. Durie, J. McCoy, J. Crowley, M. A. Hussein, S. V. Rajkumar, and M. A. Gertz
Thrombotic complications in patients with newly diagnosed multiple myeloma treated with lenalidomide and dexamethasone: benefit of aspirin prophylaxis.
Blood,
July 1, 2006;
108(1):
403 - 404.
[Full Text]
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C. Nabhan and J. D. Bitran
Thalidomide and Dexamethasone for Newly Diagnosed Multiple Myeloma: Is This Really the Standard of Care?
J. Clin. Oncol.,
June 20, 2006;
24(18):
2967 - 2968.
[Full Text]
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K. C. Anderson and P. G. Richardson
In Reply
J. Clin. Oncol.,
June 20, 2006;
24(18):
2968 - 2969.
[Full Text]
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J. Folkman, M. S. Rogers, B. Barlogie, J. Shaughnessy, and G. Tricot
Thalidomide for multiple myeloma.
N. Engl. J. Med.,
June 1, 2006;
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[Full Text]
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M. Cavo and M. Baccarani
The Changing Landscape of Myeloma Therapy
N. Engl. J. Med.,
March 9, 2006;
354(10):
1076 - 1078.
[Full Text]
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Thalidomide plus Dexamethasone for Multiple Myeloma
Journal Watch (General),
February 24, 2006;
2006(224):
6 - 6.
[Full Text]
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P. Richardson and K. Anderson
Thalidomide and Dexamethasone: A New Standard of Care for Initial Therapy in Multiple Myeloma
J. Clin. Oncol.,
January 20, 2006;
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[Full Text]
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J. A. Zonder
Thrombotic Complications of Myeloma Therapy
Hematology,
January 1, 2006;
2006(1):
348 - 355.
[Abstract]
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