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Dexamethasone With or Without Thalidomide in Treating Patients With Newly Diagnosed Multiple Myeloma
This study has been completed.
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00033332
  Purpose

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 Intervention Phase
Multiple Myeloma and Plasma Cell Neoplasm
Drug: dexamethasone
Drug: pamidronate disodium
Drug: thalidomide
Drug: zoledronic acid
Phase III

Genetics Home Reference related topics: aceruloplasminemia hemophilia
MedlinePlus related topics: Cancer Multiple Myeloma
Drug Information available for: Dexamethasone Dexamethasone acetate Dexamethasone Sodium Phosphate Doxiproct plus Thalidomide Zoledronic acid Pamidronate disodium Amidronate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed Multiple Myeloma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2002
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

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

Renal:

  • Creatinine less than 3 mg/dL

Cardiovascular:

  • No prior or concurrent deep venous thrombosis

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

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

Chemotherapy:

  • 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

Radiotherapy:

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

Surgery:

  • Not specified

Other:

  • No prior systemic therapy for multiple myeloma, except bisphosphonates
  • No concurrent anticoagulant therapy for deep vein thrombosis
  • No concurrent barbiturates or alcohol (thalidomide arm)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00033332

  Show 78 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: S. V. Rajkumar, MD Mayo Clinic
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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 D, Fonseca R, Greipp PR; Eastern Cooperative Oncology Group. 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. J Clin Oncol. 2006 Jan 20;24(3):431-6. Epub 2005 Dec 19.
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.
Greipp PR. Eastern Cooperative Oncology Group E1A00: phase III randomized study of dexamethasone with or without thalidomide in patients with newly diagnosed multiple myeloma. Clin Adv Hematol Oncol. 2003 Mar;1(3):188-9. No abstract available.

Other Publications:
Study ID Numbers: CDR0000069274, E-E1A00
Study First Received: April 9, 2002
Last Updated: October 8, 2008
ClinicalTrials.gov Identifier: NCT00033332  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma

Study placed in the following topic categories:
Dexamethasone
Immunoproliferative Disorders
Zoledronic acid
Thalidomide
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Pamidronate
Lymphoproliferative Disorders
Dexamethasone acetate
Neoplasms, Plasma Cell

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Anti-Infective Agents
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Bone Density Conservation Agents
Hormones
Anti-Bacterial Agents
Therapeutic Uses
Cardiovascular Diseases
Growth Inhibitors
Angiogenesis Modulating Agents
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Hormonal
Growth Substances
Gastrointestinal Agents
Glucocorticoids
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Leprostatic Agents

ClinicalTrials.gov processed this record on January 16, 2009