|
|
|
|
|
Sponsored by: |
Medical Research Council |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002653 |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known which combination chemotherapy regimen is most effective in treating older patients with multiple myeloma.
PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with or without cyclophosphamide and prednisone in treating older patients with multiple myeloma.
Condition | Intervention | Phase |
Multiple Myeloma and Plasma Cell Neoplasm |
Drug: carmustine Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: melphalan Drug: prednisone Procedure: radiation therapy |
Phase III |
Genetics Home Reference related topics: | aceruloplasminemia hemophilia |
MedlinePlus related topics: | Cancer Multiple Myeloma |
ChemIDplus related topics: | Doxorubicin Doxorubicin hydrochloride Cyclophosphamide Carmustine Melphalan Prednisone Melphalan hydrochloride Sarcolysin |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | VIIITH MYELOMATOSIS TRIAL: A RANDOMISED TRIAL OF TREATMENT FOR INDUCING FIRST PLATEAU PHASE ABCM VS 3 COURSES OF ABCM FOLLOWED BY ORAL WEEKLY CYCLOPHOSPHAMIDE |
Estimated Enrollment: | 1000 |
Study Start Date: | September 1993 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to center.
Patients receive doxorubicin IV followed immediately by carmustine IV over 1-2 hours on day 1 and oral melphalan (L-PAM) and oral cyclophosphamide (CTX) on days 22-25 (ABCM). Treatment continues every 6 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients whose blood counts recover within 6 weeks after beginning L-PAM and CTX during course 3 are randomized to 1 of 2 treatment arms. Patients whose blood counts fail to recover within 6 weeks after beginning L-PAM and CTX during course 3 are assigned to arm II.
Patients on both arms with bone pain or failure to respond to chemotherapy may undergo minimal radiotherapy. Patients achieving plateau phase may enter the MRC trial of interferon alfa-2b.
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study within approximately 5 years.
Ages Eligible for Study: | 65 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma, defined by at least 2 of the following conditions:
Neoplastic cell infiltrate and/or microplasmacytomas by bone marrow sections or smears
Nonsecretory disease allowed in the presence of 1 of the following conditions:
No equivocal myelomatosis, defined by the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom, England | |||||
MRC Myelomatosis Trials Office | |||||
Birmingham, England, United Kingdom, B15 2SZ |
Medical Research Council |
Study Chair: | M. T. Drayson, MD | MRC Myelomatosis Trials Office |
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
Study ID Numbers: | CDR0000064187, MRC-LEUK-MYEL-VIII, EU-94031 |
First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002653 |
Health Authority: | United States: Federal Government |
|
|
|
|
|