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Stem Cell Translpantation in Multiple Myeloma

Multiple Myeloma Clinical Trial

Official title:
A Phase-II Study Comparing Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Following Autologous Transplantation to Autologous Transplantation Alone in Multiple Myeloma

Clinical Trial Summary

The purpose of this study is to determine whether autologous transplantation (using the patient's own stem cells from the blood), followed by non-myeloablative (i.e. less intense) allogeneic transplantation (where the blood stem cells from a sibling donor are used for the transplantation) improves the outcome in patients with newly diagnosed multiple myeloma.

Clinical Trial Description

This trial includes a natural (no available HLA-identical sibling donor) control arm. Patients with newly diagnosed multiple myeloma without a sibling are initially treated with conventional chemotherapy followed by conventional single or double autologous transplant (PBSCT). Data from this group is used as part of the control group. Eligible patients with one or more sibling are offered to participate in the main trial arm. Those who decline are asked to consider taking part in the control group (autograft only). Patients consenting to participate in the main study first receive the PBSCT, followed by the HLA-matched non-myeloablative allograft (matched for HLA -A, -B, -C, -DRB1). All study patients receive four to six cycles of VAD (or alternative regimens specified in protocol) before PBSCT as first line treatment. Study entry starts at the time of starting conditioning for autologous transplantation. The search for an identical sibling donor begins as soon as the patient has consented to participate in the study. The allograft is performed when the patient has restored their marrow function but no earlier than 3 months following PBSCT. The aim is to demonstrate a difference in outcome (progression free survival, transplant related mortality, relapse rate, and survival). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05082675
Study type Interventional
Source European Society for Blood and Marrow Transplantation
Contact
Status Completed
Phase Phase 2
Start date September 2001
Completion date January 2012
View Details
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