Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006232
First received: September 11, 2000
Last updated: May 14, 2013
Last verified: March 2007

September 11, 2000
May 14, 2013
October 1996
Not Provided
Comparison of response rates [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00006232 on ClinicalTrials.gov Archive Site
  • Time to achieve a maximal response [ Designated as safety issue: No ]
  • Duration of response [ Designated as safety issue: No ]
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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.

OBJECTIVES:

  • 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.

Interventional
Phase 3
Allocation: Randomized
Primary Purpose: Treatment
Multiple Myeloma and Plasma Cell Neoplasm
  • Drug: dexamethasone
  • Drug: doxorubicin hydrochloride
  • Drug: idarubicin
  • Drug: vincristine sulfate
Not Provided
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
August 2007
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DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 75 and under

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Bilirubin no greater than 2.34 mg/dL

Renal:

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

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • See Disease Characteristics

Chemotherapy

  • See Disease Characteristics

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

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

Surgery

  • See Disease Characteristics
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00006232
WSLG-H31, CDR0000068156, EU-20032, ISRCTN65684689
Not Provided
Not Provided
West of Scotland Lymphoma Group
Not Provided
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