Study of Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma.

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

177

Participants

Timeline

Start Date

November 19, 2001

Primary Completion Date

July 15, 2013

Study Completion Date

January 30, 2018

Conditions
Multiple Myeloma
Interventions
DRUG

melphalan

(Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2)

DRUG

topotecan (TPT)

"Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2~Phase II: Treatment at maximum tolerated dose (MTD)"

PROCEDURE

Autologous Stem Cell Rescue

Day 0

Trial Locations (1)

33612

H. Lee Moffitt Cancer Center & Research Institute, Tampa

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

collaborator

National Cancer Institute (NCI)

NIH

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER