CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 205 enrolled
Drug / intervention
Busulfan +5 moredrug
Likely dose
Busulfan 32 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01413178
NCT01413178Phase 3Completed
CompareCT.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

M.D. Anderson Cancer Center·interventional·Posted Aug 10, 2011·Updated Apr 21, 2020

In Brief

A Phase 3 clinical trial evaluating Busulfan, Melphalan, and 4 other interventions for Myeloma. Completed, enrolled 205 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to compare Busulfex (busulfan) with or without Alkeran (melphalan) to learn which study therapy may be better at helping to control MM in patients who will receive an autologous stem cell transplant. The safety of this combination therapy will also be studied. Melphalan and busulfan are designed to damage the DNA (genetic material) of cells, which may cause cancer cells to die.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyeloma
CountriesUnited States
CollaboratorsOtsuka Pharmaceutical Development & Commercialization, Inc.

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2011
Enrollment StartSep 30, 2011
Primary CompletionMar 10, 2019
TodayJul 2, 2026
Enrollment to primary: 7.4 yearsPosted 14.9 years ago

Interventions

Busulfandrug

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.

Melphalandrug

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

Questionnaireother

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.

G-CSFdrug

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

High Dose Melphalandrug

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

Stem cell transplantprocedure

Stem cell infusion on Day 0.