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Br J Haematol. 2016 Jun;173(5):731-41. doi: 10.1111/bjh.13994. Epub 2016 Mar 17.

Single versus tandem high-dose melphalan followed by autologous blood stem cell transplantation in multiple myeloma: long-term results from the phase III GMMG-HD2 trial.

Author information

1
Department of Internal Medicine V, University Clinic Heidelberg, Heidelberg, Germany.
2
Division of Biostatistics, German Cancer Research Centre (DKFZ), Heidelberg, Germany.
3
Nationales Centrum für Tumorerkrankungen (NCT) Heidelberg, Heidelberg, Germany.
4
Medical Clinic and Polyclinic III, University Hospital Bonn, Bonn, Germany.
5
Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany.
6
Department of Internal Medicine II, University Clinic Würzburg, Würzburg, Germany.
7
Department of Medicine I, University Hospital Dresden Carl Gustav Carus, Dresden, Germany.
8
Department of Haematology and Oncology, Klinikum Baden Baden, Baden Baden, Germany.
9
Department of Haematology and Oncology, University Clinic Gießen/Marburg, Marburg, Germany.
10
Department of Internal Medicine I, Klinikum Bremen Mitte, Bremen, Germany.
11
Department of Haematology and Oncology, Evangelische Kliniken Bonn, Bonn, Germany.
12
Department of Internal Medicine II, Carl-Thiem Klinikum Cottbus, Cottbus, Germany.
13
Department of Internal Medicine I, University Hospital Köln, Köln, Germany.

Abstract

The prospective, randomized phase III trial GMMG-HD2 aimed at demonstrating non-inferiority of single (Arm A) versus tandem (Arm B) high-dose melphalan followed by autologous transplantation (HDM/ASCT) with regard to 2-year event-free survival (EFS) in newly-diagnosed multiple myeloma (MM) and included 358 evaluable patients [Intention-to-treat population, (ITT), single/tandem HDM/ASCT: n = 177/181]. After a median follow-up of more than 11 years, non-inferiority of single versus tandem HDM/ASCT was demonstrated using the planned non-inferiority threshold of 15% of the 2-year EFS rate. Neither EFS (P = 0·53) nor overall survival (OS) (P = 0·33) differences were observed in the ITT population. In the tandem arm, 26% (n = 47/181) of patients refused a second HDM/ASCT due to non-medical reasons. A per-protocol (PP) analysis, including patients who received the intervention (single/tandem HDM/ASCT: n = 156/93) and patients who did not receive a second HDM/ASCT due to medical reasons (12%, n = 22/181), did not yield differences in EFS (P = 0·61) or OS (P = 0·16). In the ITT and PP set of the tandem arm, the rates of complete responses increased from first to second HDM/ASCT (both P = 0·04). Ten-year OS for the entire ITT was 34% (95% confidence interval: 29-40%). OS after first relapse was significantly shortened in the tandem arm (P = 0·04). In this study single HDM/ASCT was non-inferior to tandem HDM/ASCT in MM.

KEYWORDS:

melphalan; myeloma; single transplantation; stem cell transplantation; tandem transplantation

PMID:
26990892
DOI:
10.1111/bjh.13994
[Indexed for MEDLINE]

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