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Combination Chemotherapy and Thalidomide in Treating Patients With Stage I, Stage II, or Stage III 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: NCT00054158
Recruitment Status : Completed
First Posted : February 6, 2003
Last Update Posted : January 31, 2013
National Cancer Institute (NCI)
Information provided by:
Roswell Park Cancer Institute

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in 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 chemotherapy with thalidomide may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and thalidomide in treating patients who have newly diagnosed stage I, stage II, or stage III multiple myeloma.

Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: thalidomide Drug: vincristine sulfate Phase 2

Detailed Description:


  • Determine the overall response rate in patients with newly diagnosed stage I, II, or III multiple myeloma treated with vincristine, doxorubicin, dexamethasone, and low-dose thalidomide.
  • Determine the ability to collect peripheral blood stem cells in patients after treatment with this regimen.

OUTLINE: This is an open-label, nonrandomized study.

Patients receive vincristine IV and doxorubicin IV continuously on days 1-4 and oral dexamethasone on days 1-4, 9-12, and 17-20. Patients also receive low-dose oral thalidomide daily on days 1-28. Treatment repeats every 4 weeks for 4-6 courses in the absence of disease progression.

Patients are followed until disease progression or bone marrow transplantation.

PROJECTED ACCRUAL: Approximately 17-37 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of VAD (Vincristine, Adriamycin, Dexamethasone) Plus Thalidomide (Low Dose) as Frontline Therapy for Newly Diagnosed Patients With Multiple Myeloma (MM)
Study Start Date : August 2004
Actual Primary Completion Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
Drug Information available for: Thalidomide

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 stage I, II, or III multiple myeloma (MM)
  • No refractory or relapsed MM



  • 18 and over

Performance status

  • Karnofsky 60-100%

Life expectancy

  • Not specified


  • Not specified


  • Bilirubin less than 1.5 mg/dL
  • AST less than 2.5 times upper limit of normal


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use 2 effective methods of contraception (including at least 1 highly active method) for at least 4 weeks before, during, and for at least 4 weeks after study participation
  • No active serious infections uncontrolled by antibiotics
  • No insufficient mental capacity that would preclude informed consent
  • No other medical condition or reason that would preclude study participation
  • Willing and able to comply with the FDA-mandated S.T.E.P.S program


Biologic therapy

  • No prior thalidomide


  • No more than 1 course of prior vincristine, doxorubicin, and dexamethasone

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified


  • No concurrent alcohol consumption

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): NCT00054158

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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
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Study Chair: Asher A. Chanan-Khan, MD Roswell Park Cancer Institute

Layout table for additonal information Identifier: NCT00054158     History of Changes
Other Study ID Numbers: RP 02-15
First Posted: February 6, 2003    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013
Keywords provided by Roswell Park Cancer Institute:
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
Dexamethasone acetate
Liposomal doxorubicin
BB 1101
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents