Trial | NCT00006232  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    200
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.
Study Started
Oct 31
1996
Study Completion
Aug 31
2007
Last Update
May 15
2013
Estimate

Drug dexamethasone

Drug doxorubicin hydrochloride

Drug idarubicin

Drug vincristine sulfate

Criteria 

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
No Results Posted