High Dose Sequential Therapy and Autologous Stem Cell Rescue for Multiple Myeloma

PHASE2CompletedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

May 31, 1997

Primary Completion Date

January 31, 2006

Study Completion Date

February 29, 2008

Conditions
Multiple Myeloma
Interventions
PROCEDURE

High-Dose Sequential Chemotherapy followed by ASCT

Patient will receive Cyclophosphamide(4 g/m2 over 2 hours) and blood progenitor cell collection (day -49). G-CSF (10 mcg/kg/d) will be administered SQ. A six hour leukapheresis will be performed,cells will undergo CD34+ cell selection, patients will receive high dose VP-16 (Etopophos)(day -28)(2 g/m2 over 4 hours)and G-CSF (5 mcg/kg/d) will be administered SQ two days following VP-16. The an IV of sulfamethoxazole-trimethoprim 1 ampule BID for 5 days (Day -5). BCNU 500 mg/m2 IV over 2 hours (Day -4). Melphalan (Day -2) will be administered IV (200 mg/m2 over 20 minutes). The frozen peripheral blood mononuclear cells will be transfused on Day 0. Day +1: G-CSF 5 mcg/kg/d SQ for 3 days.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Duke University

OTHER