NCT01413178View on ClinicalTrials.gov

A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma

PHASE3CompletedINTERVENTIONAL
Enrollment

205

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

March 10, 2019

Study Completion Date

March 10, 2019

Conditions
Myeloma
Interventions
DRUG

Busulfan

Test dose (32 mg/m\^2) on day -9 then 130 mg/m\^2 by vein or adjusted dose on Days -7, -6, -5, and -4.

DRUG

Melphalan

70 mg/m2 by vein over 30 minutes minutes on Days -2 and -1.

OTHER

Questionnaire

Quality of Life (QOL) questionnaire before starting the study drugs and then once every 4 weeks after the stem cell transplant, taking about 15 minutes to complete.

DRUG

G-CSF

Approximately 5 mcg/kg/day subcutaneously beginning on Day +5.

DRUG

High Dose Melphalan

200 mg/m2 by vein over 30 minutes on Day -2.

PROCEDURE

Stem cell transplant

Stem cell infusion on Day 0.

Trial Locations (1)

77030

University of Texas MD Anderson Cancer Center, Houston

All Listed Sponsors
collaborator

Otsuka Pharmaceutical Development & Commercialization, Inc.

INDUSTRY

lead

M.D. Anderson Cancer Center

OTHER

NCT01413178 - A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma | Biotech Hunter | Biotech Hunter