Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Melphalan Followed by Peripheral Stem Cell Transplantation in Treating Patients With 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:

 -  Administer standard, high dose melphalan safely in a closely monitored setting in
 patients with responsive multiple myeloma.

 -  Determine the cost and time effectiveness in the collection of sufficient peripheral
 blood stem cells (PBSC) for two high dose melphalan therapies and PBSC transplantations
 in this patient population.

 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:

 -  Lytic disease

 -  Anemia

 -  Hypercalcemia

 -  Secondary renal insufficiency

 -  More than 400 mg/24 hours of urinary protein excretion

 -  Symptomatic hyperviscosity

 -  If previously treated, refractory to no more than 1 regimen

 -  Primary amyloidosis without subsequent multiple myeloma allowed

 -  Abnormal renal function allowed if due to primary disease

 PATIENT CHARACTERISTICS:

 Age:

 -  Not specified

 Performance status:

 -  Not specified

 Life expectancy:

 -  Not specified

 Hematopoietic:

 -  Not specified

 Hepatic:

 -  Not specified

 Renal:

 -  See Disease Characteristics

 -  Creatinine clearance greater than 50 mL/min if no renal impairment

 Cardiovascular:

 -  No cardiac function that would preclude study

 -  LVEF greater than 45%

 Pulmonary:

 -  No pulmonary function that would preclude study

 -  FVC greater than 60% predicted

 -  DLCO greater than 50% predicted

 Other:

 -  Not pregnant or nursing

 -  Fertile patients must use effective contraception

 PRIOR CONCURRENT THERAPY:

 Biologic therapy

 -  Not specified

 Chemotherapy

 -  No greater than 18 months of prior alkylator exposure

 Endocrine therapy

 -  Not specified

 Radiotherapy

 -  Not specified

 Surgery

 -  Not specified

 Other

 -  See Disease Characteristics

 -  No more than 3 prior treatment regimens allowed