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

Multiple Myeloma and Plasma Cell Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00006232
• Other study ID #: WSLG-H31
• Secondary ID: CDR0000068156EU-
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2000
• Last updated: May 14, 2013
• Start date: October 1996
• Est. completion date: August 2007

Study information

• Verified date: March 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Neoplasms, Plasma Cell
• Plasmacytoma

Intervention

Drug:
• dexamethasone

• doxorubicin hydrochloride

• idarubicin

• vincristine sulfate

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen	Scotland
United Kingdom	Vale Of Leven D G Hospital	Alexandria	Scotland
United Kingdom	Centre for Cancer Research and Cell Biology at Belfast City Hospital	Belfast	Northern Ireland
United Kingdom	Birmingham Heartlands Hospital	Birmingham	England
United Kingdom	Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust	Cambridge	England
United Kingdom	Dumfries Royal Infirmary	Dumfries	Scotland
United Kingdom	Ninewells Hospital and Medical School	Dundee	Scotland
United Kingdom	Royal Infirmary - Castle	Glasgow	Scotland
United Kingdom	West of Scotland Cancer Centre	Glasgow	Scotland
United Kingdom	Royal Liverpool and Broadgreen Hospitals NHS Trust	Liverpool	England
United Kingdom	Royal Alexandra Hospital	Paisley	Scotland
United Kingdom	New Cross Hospital	Wolverhampton	England

Sponsors (1)

Lead Sponsor	Collaborator
West of Scotland Lymphoma Group

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of response rates			No
Secondary	Time to achieve a maximal response			No
Secondary	Duration of response			No