Combination Chemotherapy in Treating Patients With Stage II or Stage III Multiple Myeloma
This study has been completed.
Sponsor:
West of Scotland Lymphoma Group
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006232
First received: September 11, 2000
Last updated: May 14, 2013
Last verified: March 2007
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | A Randomized Trial Comparing Z-Dex With VAD as Induction Therapy for Patients With Multiple Myeloma |
Resource links provided by NLM:
Drug Information available for:
Dexamethasone
Dexamethasone acetate
Vincristine sulfate
Dexamethasone sodium phosphate
Doxorubicin
Doxorubicin hydrochloride
Idarubicin hydrochloride
Idarubicin
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 |
| Study Completion Date: | August 2007 |
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 | |
| 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 | |
| Royal Infirmary - Castle | |
| Glasgow, Scotland, United Kingdom, G4 0SF | |
| West of Scotland Cancer Centre | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| 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
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006232 History of Changes |
| Other Study ID Numbers: | WSLG-H31, CDR0000068156, EU-20032, ISRCTN65684689 |
| Study First Received: | September 11, 2000 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
stage II multiple myeloma stage III multiple myeloma |
Additional relevant MeSH terms:
|
Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Plasmacytoma Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
Dexamethasone acetate Dexamethasone Dexamethasone 21-phosphate Doxorubicin Idarubicin Vincristine BB 1101 Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013