Trial intelligence / Profile preview

IV Busulfan and Melphalan Conditioning for ASCT in Elderly Multiple Myeloma

NCT00804947Phase 2

Key facts

Status: Unknown
Start: Sep 2005
Primary completion: Mar 2010
Countries: 1
Sponsor: Health Research Institute Hospital La Fe
Modality: Small Molecules

Drugs: busulfanmelphalan
Conditions: multiple myeloma (MM)

Overview

Phase 2, open-label, single-arm trial of busulfan and melphalan in multiple myeloma (MM), sponsored by Health Research Institute Hospital La Fe. Primary endpoints: Safety profile of the procedure at 3 months and Overall Response Rate at 3 months. Status: unknown.

Design

1 arm

Study design: Non-randomizedOpen-label

Intravenous busulfan and melphalan
IV Busulfan 3.2 mg/kg/day (Days -5 to -3) + Melphalan 140 mg/m2 (Day -2) followed by ASCT

Who it enrols

Patients >= 70 years with symptomatic multiple myeloma who have received at least one prior line of therapy. Inclusion requires front-line treatment with VBMCP/VBAD/VAD or second-line therapy with bortezomib/thalidomide/lenalidomide. Use of bortezomib, thalidomide, or lenalidomide as front-line therapy is excluded.

Endpoints

Primary

Safety profile of the procedure3 months
Overall Response Rate3 months

Secondary

Complete Response Rate5 years
Duration of Response5 years
Time to Progression5 years
Event-Free Survival5 years
Overall Survival5 years
Time to neutrophil recovery
Time to platelet recovery
Transplant-related complications

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