Combination Chemotherapy in Treating Patients With 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: NCT00006232
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 15, 2013
Information provided by:
National Cancer Institute (NCI)

September 11, 2000
January 27, 2003
May 15, 2013
October 1996
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Comparison of response rates
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Complete list of historical versions of study NCT00006232 on Archive Site
  • Time to achieve a maximal response
  • Duration of response
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Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapy regimen is more effective for multiple myeloma.

PURPOSE: This randomized phase III trial is comparing two combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III multiple myeloma.


  • Compare the partial and complete response rates in patients with multiple myeloma treated with induction therapy comprising idarubicin and dexamethasone vs vincristine, doxorubicin, and dexamethasone.
  • Compare the disease progression, time to achieve maximal response, and duration of response in patients treated with these 2 regimens.
  • Compare the quality of life of patients treated with these 2 regimens.

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

  • Arm I: Patients receive oral idarubicin and oral dexamethasone daily on days 1-4. Treatment continues every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients also receive oral dexamethasone daily on days 8-11 during course 1 only.
  • Arm II: Patients receive oral dexamethasone daily, doxorubicin IV continuously, and vincristine IV continuously on days 1-4. Courses repeat as in arm I. Patients receive additional dexamethasone as in arm I.

Patients without a maximal response after completion of course 4 may receive up to 2 additional courses.

Quality of life is assessed at baseline and then prior to each study course.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 200 patients (100 per arm) will be accrued for this study within 2 years.

Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Multiple Myeloma and Plasma Cell Neoplasm
  • Drug: dexamethasone
  • Drug: doxorubicin hydrochloride
  • Drug: idarubicin
  • Drug: vincristine sulfate
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2007
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  • Diagnosis of stage II or III multiple myeloma

    • No prior therapy except local radiotherapy to bone lesions
  • No indolent multiple myeloma
  • No monoclonal gammopathy of unknown significance



  • 75 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Bilirubin no greater than 2.34 mg/dL


  • No end stage renal failure (creatinine greater than 5.65 mg/dL after rehydration)
  • No requirement for dialysis


  • No other medical condition that would preclude intensive treatment
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other prior malignancy


Biologic therapy

  • See Disease Characteristics


  • See Disease Characteristics

Endocrine therapy

  • See Disease Characteristics


  • Concurrent local radiotherapy allowed for painful lesions or lesions that appear likely to lead to an imminent fracture


  • See Disease Characteristics
Sexes Eligible for Study: All
up to 75 Years   (Child, Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
CDR0000068156 ( Registry Identifier: PDQ (Physician Data Query) )
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West of Scotland Lymphoma Group
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Study Chair: Gordon Cook, MD, PhD Leeds Cancer Centre at St. James's University Hospital
National Cancer Institute (NCI)
March 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP