Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma - Full Text View

Sponsored by:	West of Scotland Lymphoma Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006232

Purpose

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	Intervention	Phase
Multiple Myeloma and Plasma Cell Neoplasm	Drug: dexamethasone Drug: doxorubicin hydrochloride Drug: idarubicin Drug: vincristine sulfate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma

Resource links provided by NLM:

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Cancer Multiple Myeloma

Drug Information available for: Dexamethasone Vincristine Doxorubicin Doxorubicin hydrochloride Dexamethasone acetate Idarubicin hydrochloride Idarubicin Doxiproct plus Myocet Dexamethasone Sodium Phosphate Vincristine sulfate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Comparison of response rates [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to achieve a maximal response [ Designated as safety issue: No ]
Duration of response [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	October 1996

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

Ages Eligible for Study:	up to 75 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006232

Locations

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

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

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000068156, WSLG-H31, EU-20032, ISRCTN65684689
Study First Received:	September 11, 2000
Last Updated:	August 23, 2008
ClinicalTrials.gov Identifier:	NCT00006232 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage II multiple myeloma
stage III multiple myeloma

Study placed in the following topic categories:

Dexamethasone
Anti-Inflammatory Agents
Blood Protein Disorders
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Hemostatic Disorders
Hormones
Anti-Bacterial Agents
Hemorrhagic Disorders
Dexamethasone acetate
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal

Hematologic Diseases
Blood Coagulation Disorders
Vascular Diseases
Vincristine
Antimitotic Agents
Glucocorticoids
Doxorubicin
Multiple Myeloma
Idarubicin
Tubulin Modulators
Peripheral Nervous System Agents
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Dexamethasone
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Blood Protein Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Paraproteinemias
Antibiotics, Antineoplastic
Hemostatic Disorders
Hormones
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases

Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Hematologic Diseases
Mitosis Modulators
Gastrointestinal Agents
Vascular Diseases
Vincristine
Antimitotic Agents
Glucocorticoids
Doxorubicin
Pharmacologic Actions
Multiple Myeloma
Neoplasms

ClinicalTrials.gov processed this record on July 02, 2009