Stem Cell Transplant as Standard Therapy for Symptomatic Multiple Myeloma
- 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.
Primary Purpose: Treatment
Ann Traynor, MD
Robert H. Lurie Cancer Center
United States: Federal Government
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|