VIIITH MYELOMATOSIS TRIAL: A RANDOMISED TRIAL OF TREATMENT FOR INDUCING FIRST PLATEAU PHASE ABCM VS 3 COURSES OF ABCM FOLLOWED BY ORAL WEEKLY CYCLOPHOSPHAMIDE
65 Years
74 Years
Both
Multiple Myeloma and Plasma Cell Neoplasm
Trial Information
VIIITH MYELOMATOSIS TRIAL: A RANDOMISED TRIAL OF TREATMENT FOR INDUCING FIRST PLATEAU PHASE ABCM VS 3 COURSES OF ABCM FOLLOWED BY ORAL WEEKLY CYCLOPHOSPHAMIDE
OBJECTIVES:
- Compare the efficacy of doxorubicin, carmustine, cyclophosphamide, and melphalan (ABCM)
with or without oral cyclophosphamide and prednisone as induction for the first plateau
phase in elderly patients with previously untreated multiple myeloma.
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.
- Arm I: Patients continue ABCM for a maximum of 12 courses in the absence of a plateau
phase after completion of at least 4 courses, disease progression, or unacceptable
toxicity.
- Arm II: Patients receive oral cyclophosphamide once weekly and oral prednisone every
other day. Treatment continues every 6 weeks in the absence of a plateau phase after
completion of 3 courses of ABCM plus a minimum of 8 weeks on arm II or less than 3
courses of ABCM plus 6 months on arm II, disease progression, or unacceptable toxicity.
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.
Inclusion Criteria
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
- Plasma cell infiltrates greater than 20% of marrow nucleated cells or, if
less than 20%, objective evidence of monoclonality of the plasma cells
required
- Paraprotein in blood or urine
- Definite lytic bone lesions (not osteoporosis)
- Nonsecretory disease allowed in the presence of 1 of the following conditions:
- Microplasmacytomas
- Monoclonal plasmacytosis with immunoglobulin light-chain expression in cytoplasm
- No equivocal myelomatosis, defined by the following criteria:
- Minimal or no symptoms attributable to myelomatosis
- Pretransfusion hemoglobin greater than 10 g/dL
- Post-hydration creatinine less than 1.47 mg/dL
- No osteolytic lesions except minimal lesions that do not threaten pathological
fracture and are not associated with pain
- Plasma cells less than 30% of marrow nucleated cells and marrow showing normal
hematopoietic activity
- Serum beta-2 microglobulin less than 4 mg/L
- Less than 1 g of free light-chain excretion per 1 g of creatinine
- No objective factors indicating progressive myelomatosis
PATIENT CHARACTERISTICS:
Age:
- 65 to 74
- If under 65, higher priority is given to protocol MRC-LEUK-MYEL-VII unless entry into
this study would be more appropriate
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
- Neutrophil count at least 1,300/mm^3
- Platelet count at least 75,000/mm^3
Hepatic:
- Not specified
Renal:
- See Disease Characteristics
Other:
- Ability to tolerate fluid intake of at least 3 L/day beginning at least 2 days before
study entry
- Afebrile and free of infection
- No contraindication to therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy
Endocrine therapy:
- Prior or concurrent prednisolone at 30 mg/m2/day or less (or equivalent doses of
other corticosteroids) for relief of fluid-unresponsive hypercalcemia allowed
Radiotherapy:
- Prior or concurrent minimal local radiotherapy to relieve persistent bone pain or
cord compression allowed
Surgery:
- Not specified
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Primary Purpose: Treatment
Principal Investigator
M. T. Drayson, MD
Investigator Role:
Study Chair
Investigator Affiliation:
MRC Myelomatosis Trials Office
Authority:
United States: Federal Government
Study ID:
CDR0000064187
NCT ID:
NCT00002653
Start Date:
September 1993
Completion Date:
Related Keywords:
- Multiple Myeloma and Plasma Cell Neoplasm
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- Neoplasms
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
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