Clinical trial NCT00006232: Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
Official title: A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Myeloma and Plasma Cell Neoplasm
Keywords: stage II multiple myeloma
stage III multiple myeloma
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Enrollment: 200
Sex: ALL
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Comparison of response rates
Secondary outcomes:
measure: Time to achieve a maximal response
measure: Duration of response
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: Birmingham Heartlands Hospital
state: England
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
state: England
city: Liverpool
country: United Kingdom
facility: Royal Liverpool and Broadgreen Hospitals NHS Trust
state: England
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: England
city: Belfast
country: United Kingdom
facility: Centre for Cancer Research and Cell Biology at Belfast City Hospital
state: Northern Ireland
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
state: Scotland
city: Alexandria
country: United Kingdom
facility: Vale Of Leven D G Hospital
state: Scotland
city: Dumfries
country: United Kingdom
facility: Dumfries Royal Infirmary
state: Scotland
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School
state: Scotland
city: Glasgow
country: United Kingdom
facility: West of Scotland Cancer Centre
state: Scotland
city: Glasgow
country: United Kingdom
facility: Royal Infirmary - Castle
state: Scotland
city: Paisley
country: United Kingdom
facility: Royal Alexandra Hospital
state: Scotland
Study officials:
affiliation: Leeds Cancer Centre at St. James's University Hospital
name: Gordon Cook, MD, PhD
role: STUDY_CHAIR
References: