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Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00033332
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 4, 2014
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. Combining dexamethasone and thalidomide may kill more cancer cells. It is not yet known whether dexamethasone is more effective with or without thalidomide in treating multiple myeloma.

PURPOSE: Randomized phase III trial to determine the effectiveness of dexamethasone with or without thalidomide in treating patients who have multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: dexamethasone Drug: pamidronate disodium Drug: thalidomide Drug: zoledronic acid Phase 3

Detailed Description:


  • Compare the response rate of patients with newly diagnosed multiple myeloma treated with dexamethasone with or without thalidomide.
  • Compare the toxicity of these regimens in these patients.
  • Assess the effect of thalidomide on bone marrow microvessel density and angiogenesis grade and on the expression of vascular endothelial growth factor and basic fibroblast growth factor in these patients.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral thalidomide once daily on days 1-28 and oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients also receive either pamidronate IV over 2-4 hours or zoledronate IV over 15 minutes on day 1 for bone strengthening.
  • Arm II: Patients receive dexamethasone and pamidronate or zoledronate as in arm I.

Treatment in both arms repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients may receive additional courses after the fourth course at the physician's discretion.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 2 years.

PROJECTED ACCRUAL: A total of 194 patients (97 per treatment arm) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed Multiple Myeloma
Study Start Date : April 2002
Actual Primary Completion Date : March 2006
Actual Study Completion Date : June 2006

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Newly diagnosed symptomatic multiple myeloma confirmed by the following:

    • Bone marrow plasmacytosis with at least 10% plasma cells or sheets of plasma cells or biopsy-proven plasmacytosis
    • Monoclonal protein (M protein) at least 1.0 g/dL on serum protein electrophoresis or at least 200 mg of monoclonal light chain on a 24-hour urine protein electrophoresis
  • No smoldering myeloma or monoclonal gammopathy of undetermined significance



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count greater than 1,000/mm^3
  • Platelet count greater than 50,000/mm^3
  • Hemoglobin greater than 7 g/dL


  • Bilirubin no greater than 1.5 mg/dL
  • ALT and AST no greater than 2.5 times upper limit of normal


  • Creatinine less than 3 mg/dL


  • No prior or concurrent deep venous thrombosis


  • Prior malignancy allowed provided the following criteria are met:

    • Received prior treatment with curative intent
    • Free of disease for the time period appropriate for cure of the specific cancer
  • No grade 2 or greater peripheral neuropathy due to other medical conditions
  • No active infection
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 1 highly effective method and 1 additional method of contraception for 1 month before, during, and for 4 weeks after study for women and effective barrier contraception for men during and for 4 weeks after study participation


Biologic therapy:

  • No prior biologic therapy for multiple myeloma
  • No other concurrent biologic therapy for multiple myeloma


  • No prior chemotherapy for multiple myeloma
  • No other concurrent chemotherapy for multiple myeloma

Endocrine therapy:

  • More than 6 months since prior systemic dexamethasone or glucocorticoids
  • No concurrent corticosteroids


  • At least 4 weeks since prior palliative, localized radiotherapy
  • Concurrent palliative, localized radiotherapy allowed at the physician's discretion


  • Not specified


  • No prior systemic therapy for multiple myeloma, except bisphosphonates
  • No concurrent anticoagulant therapy for deep vein thrombosis
  • No concurrent barbiturates or alcohol (thalidomide arm)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00033332

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Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: S. V. Rajkumar, MD Mayo Clinic

Publications of Results:
Kumar S, Greipp PR, Haug JL, et al.: Correlation of bone marrow angiogenesis and response to thalidomide dexamethasone in multiple myeloma. [Abstract] J Clin Oncol 24 (Suppl 18): A-7621, 451s, 2006.
Rajkumar SV, Blood E, Vesole DH, et al.: A randomised phase III trial of thalidomide plus dexamethasone versus dexamethasone in newly diagnosed multiple myeloma (E1A00): a trial coordinated by the Eastern Cooperative Oncology Group. [Abstract] J Clin Oncol 22 (Suppl 14): A-6508, 560s, 2004.
Rajkumar SV, Blood E, Vesole DH, et al.: Thalidomide plus dexamethasone versus dexamethasone alone in newly diagnosed multiple myeloma (E1A00): results of a phase III trial coordinated by the Eastern Cooperative Oncology Group. [Abstract] Blood 104 (11): A-205, 2004.

Other Publications:
Layout table for additonal information Identifier: NCT00033332    
Other Study ID Numbers: CDR0000069274
U10CA021115 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 4, 2014
Last Verified: November 2005
Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Zoledronic Acid
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists