Stem Cell Transplant as Standard Therapy for Symptomatic Multiple Myeloma
Stem Cell Transplant as Standard Therapy for Symptomatic Multiple Myeloma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells.
PURPOSE: Phase III trial to study the effectiveness of melphalan followed by peripheral stem cell transplantation in treating patients who have multiple myeloma.
OBJECTIVES:
OUTLINE: Patients not in remission receive 3-6 courses of remission induction therapy consisting of either an anthracycline/glucocorticoid regimen or high dose glucocorticoids.
At 21-45 days following induction therapy, patients receive filgrastim (G-CSF) subcutaneously daily for 4 days followed by daily peripheral blood stem cell (PBSC) collection beginning on day 4 and continuing until the target number of cells is reached.
At 5 days to 6 weeks following PBSC collection, patients receive high dose melphalan IV over 2 hours for 2 consecutive days. At 36-48 hours following completion of melphalan, patients receive infusion of PBSC followed by G-CSF subcutaneously daily until blood counts recover.
At 3 months to 5 years following high dose therapy and PBSC infusion, patients with evidence of disease progression receive an additional treatment with high dose melphalan followed by PBSC infusion as in the first course.
Patients are followed at 30-45 days, 6 months, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60-120 patients will be accrued for this study over 5 years.
DISEASE CHARACTERISTICS:
Diagnosed active multiple myeloma defined by:
If previously treated, refractory to no more than 1 regimen
Primary amyloidosis without subsequent multiple myeloma allowed
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other