NCT00004165

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

Stem Cell Transplant as Standard Therapy for Symptomatic Multiple Myeloma

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: —
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Myeloma and Plasma Cell Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	filgrastim
DRUG	melphalan
PROCEDURE	peripheral blood stem cell transplantation

Timeline

• Start date: 1999-10-01
• Primary completion: 2003-08-01
• Completion: 2003-08-01
• First posted: 2003-01-27
• Last updated: 2012-06-06

Locations

1 site across 1 country: United States