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

Study Description

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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

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Study Type :	Interventional (Clinical Trial)
Estimated 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 :	October 1996
Actual Study Completion Date :	August 2007

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Comparison of response rates

Secondary Outcome Measures :

1. Time to achieve a maximal response
2. Duration of response

Eligibility Criteria

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Ages Eligible for Study:	up to 75 Years (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

West of Scotland Lymphoma Group

Investigators

Study Chair:	Gordon Cook, MD, PhD	Leeds Cancer Centre at St. James's University Hospital

More Information

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ClinicalTrials.gov Identifier:	NCT00006232 History of Changes
Other Study ID Numbers:	WSLG-H31; CDR0000068156 ( Registry Identifier: PDQ (Physician Data Query) ); EU-20032; ISRCTN65684689
First Posted:	January 27, 2003
Last Update Posted:	May 15, 2013
Last Verified:	March 2007

Keywords provided by National Cancer Institute (NCI):

stage II multiple myeloma; stage III multiple myeloma

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases	Dexamethasone; Liposomal doxorubicin; Doxorubicin; Vincristine; Idarubicin; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal