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

Sponsor

West of Scotland Lymphoma Group (Other)

Overall Status

Completed

CT.gov ID

NCT00006232

Collaborator

(none)

200

Enrollment

Locations

130

Duration (Months)

16.7

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: idarubicin Drug: vincristine sulfate	Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Primary Purpose:

Treatment

Official Title:

A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma

Study Start Date :

Oct 1, 1996

Actual Study Completion Date :

Aug 1, 2007

Outcome Measures

Primary Outcome Measures

Comparison of response rates []

Secondary Outcome Measures

Time to achieve a maximal response []
Duration of response []

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Heartlands Hospital	Birmingham	England	United Kingdom	B9 5SS
2	Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust	Cambridge	England	United Kingdom	CB2 2QQ
3	Royal Liverpool and Broadgreen Hospitals NHS Trust	Liverpool	England	United Kingdom	L7 8XP
4	New Cross Hospital	Wolverhampton	England	United Kingdom	WV10 0QP
5	Centre for Cancer Research and Cell Biology at Belfast City Hospital	Belfast	Northern Ireland	United Kingdom	BT9 7AB
6	Aberdeen Royal Infirmary	Aberdeen	Scotland	United Kingdom	AB25 2ZN
7	Vale Of Leven D G Hospital	Alexandria	Scotland	United Kingdom	G83 0UA
8	Dumfries Royal Infirmary	Dumfries	Scotland	United Kingdom	DG1 4AP
9	Ninewells Hospital and Medical School	Dundee	Scotland	United Kingdom	DD1 9SY
10	West of Scotland Cancer Centre	Glasgow	Scotland	United Kingdom	G11 6NT
11	Royal Infirmary - Castle	Glasgow	Scotland	United Kingdom	G4 0SF
12	Royal Alexandra Hospital	Paisley	Scotland	United Kingdom