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Journal of Clinical Oncology, Vol 21, Issue 1 (January), 2003: 16-19
© 2003 American Society for Clinical Oncology

Thalidomide Alone or With Dexamethasone for Previously Untreated Multiple Myeloma

Donna Weber, Kim Rankin, Maria Gavino, Kay Delasalle, Raymond Alexanian

From the The University of Texas MD Anderson Cancer Center, Houston, TX.

Address reprint requests to Donna Weber, MD, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Box 429, Houston, TX 77030, email: dmweber{at}mdanderson.org.

Purpose: To evaluate the activity of thalidomide in patients with asymptomatic multiple myeloma and of thalidomide-dexamethasone in patients with previously untreated symptomatic myeloma.

Patients and Methods: Twenty-eight patients with previously untreated asymptomatic myeloma were treated with thalidomide 100 to 200 mg orally (PO) at bedtime (qhs) with serial increments of 50 to 100 mg at weekly intervals, as tolerated to a maximum of 600 mg PO qhs. Forty consecutive previously untreated patients with symptomatic myeloma were also treated as above (maximum dose 400 mg) and received dexamethasone 20 mg/m2 for 4 days beginning on days 1, 9, and 17; the second and third cycles of repeated dexamethasone were begun on day 30. Both groups of patients were treated for at least 3 months.

Results: The response rate was 36% for patients treated with thalidomide alone and 72% for patients treated with thalidomide-dexamethasone, the latter including complete remission in 16% of patients. The median time to remission was 4.2 months with thalidomide alone and 0.7 months with thalidomide-dexamethasone. Grade 3 toxicity included infections (nine patients) and thrombotic/embolic events (seven patients). Five deaths have occurred as a result of multiple myeloma (two patients), infection (one patient), unknown cause (one patient), and a possible thromboembolic event (one patient).

Conclusion: Thalidomide alone was effective in patients with newly diagnosed myeloma. The combination with dexamethasone induced a high frequency of response, rapid onset of remission, and low incidence of serious irreversible toxicity. These observations support further studies of this promising combination for patients with newly diagnosed multiple myeloma.

Supported by the myeloma research funds established by Hill and Knowlton (in honor of William Max Watson) and Kay Laro.

Thalidomide provided by Celgene Corporation, Warren, NJ.


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 ASH Education BookHome page
J.-L. Harousseau, J. Shaughnessy Jr., and P. Richardson
Multiple Myeloma
Hematology, January 1, 2004; 2004(1): 237 - 256.
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 BloodHome page
B. Barlogie, J. Shaughnessy, G. Tricot, J. Jacobson, M. Zangari, E. Anaissie, R. Walker, and J. Crowley
Treatment of multiple myeloma
Blood, January 1, 2004; 103(1): 20 - 32.
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 JCOHome page
M. A. Dimopoulos, A. Anagnostopoulos, and D. Weber
Treatment of Plasma Cell Dyscrasias With Thalidomide and Its Derivatives
J. Clin. Oncol., December 1, 2003; 21(23): 4444 - 4454.
[Abstract] [Full Text] [PDF]

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 The OncologistHome page
E. K. Rowinsky
Crossing the Cancer Cell Membrane to Improve Clinical Outcomes
Oncologist, December 1, 2003; 8(90003): 1 - 4.
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 The OncologistHome page
M. A. Hussein
Modifications to Therapy for Multiple Myeloma: Pegylated Liposomal Doxorubicin in Combination With Vincristine, Reduced-Dose Dexamethasone, and Thalidomide
Oncologist, December 1, 2003; 8(90003): 39 - 45.
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 JCOHome page
C. Loprinzi and S. V. Rajkumar
Why Not Start With Thalidomide?
J. Clin. Oncol., June 1, 2003; 21(11): 2211 - 2214.
[Full Text] [PDF]

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 NEJMHome page
A. E. Morgan, W. K. Smith, and J. L. Levenson
Reversible Dementia Due to Thalidomide Therapy for Multiple Myeloma
N. Engl. J. Med., May 1, 2003; 348(18): 1821 - 1822.
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 The Annals of PharmacotherapyHome page
J. L Thompson and L. A. Hansen
Thalidomide Dosing in Patients with Relapsed or Refractory Multiple Myeloma
Ann. Pharmacother., April 1, 2003; 37(4): 571 - 576.
[Abstract] [Full Text] [PDF]

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 ASH Education BookHome page
S. Barille-Nion, B. Barlogie, R. Bataille, P. L. Bergsagel, J. Epstein, R. G. Fenton, J. Jacobson, W. M. Kuehl, J. Shaughnessy, and G. Tricot
Advances in Biology and Therapy of Multiple Myeloma
Hematology, January 1, 2003; 2003(1): 248 - 278.
[Abstract] [Full Text] [PDF]


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