Stem Cell Transplant as Standard Therapy for Symptomatic Multiple Myeloma
filgrastim
+ melphalan
+ peripheral blood stem cell transplantation
Amyloidosis+17
+ Blood Protein Disorders
+ Cardiovascular Diseases
Treatment Study
Summary
Study start date: October 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, United StatesOpen Robert H. Lurie Comprehensive Cancer Center, Northwestern University in Google Maps