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

被引：54

作者：

Mai, Elias K. ^{[1
]}

Benner, Axel ^{[2
]}

Bertsch, Uta ^{[1
,3
]}

Brossart, Peter ^{[4
]}

Haenel, Annette ^{[5
]}

Kunzmann, Volker ^{[6
]}

Naumann, Ralph ^{[7
,14
]}

Neben, Kai ^{[8
]}

Egerer, Gerlinde ^{[1
]}

Ho, Anthony D. ^{[1
]}

Hillengass, Jens ^{[1
]}

Raab, Marc S. ^{[1
]}

Neubauer, Andreas ^{[9
]}

Peyn, Astrid ^{[10
]}

Ko, Yon-Dschun ^{[11
]}

Peter, Norma ^{[12
]}

Scheid, Christof ^{[13
]}

Goldschmidt, Hartmut ^{[1
,3
]}

机构：

[1] Univ Clin Heidelberg, Dept Internal Med 5, D-69120 Heidelberg, Germany

[2] German Canc Res Ctr, Div Biostat, Heidelberg, Germany

[3] Natl Ctr Tumorerkrankungen NCT Heidelberg, Heidelberg, Germany

[4] Univ Hosp Bonn, Med Clin & Polyclin 3, Bonn, Germany

[5] Klinikum Chemnitz, Dept Internal Med 3, Chemnitz, Germany

[6] Univ Clin Wurzburg, Dept Internal Med 2, Wurzburg, Germany

[7] Univ Hosp Dresden Carl Gustav Carus, Dept Med 1, Dresden, Germany

[8] Klinikum Baden Baden, Dept Haematol & Oncol, Baden Baden, Germany

[9] Univ Clin Giessen Marburg, Dept Haematol & Oncol, Marburg, Germany

[10] Klinikum Bremen Mitte, Dept Internal Med 1, Bremen, Germany

[11] Kliniken Bonn, Dept Haematol & Oncol, Bonn, Germany

[12] Carl Thiem Klinikum Cottbus, Dept Internal Med 2, Cottbus, Germany

[13] Univ Hosp Koln, Dept Internal Med 1, Cologne, Germany

[14] Gemeinschaftsklinikum Mittelrhein, Dept Haematol & Oncol, Koblenz, Germany

来源：

BRITISH JOURNAL OF HAEMATOLOGY | 2016年 / 173卷 / 05期

关键词：

myeloma; stem cell transplantation; single transplantation; tandem transplantation; melphalan; RANDOMIZED-TRIAL; INTERGROUPE FRANCOPHONE; MARROW-TRANSPLANTATION; 200 MG/M(2); THERAPY; MAINTENANCE; BORTEZOMIB; INDUCTION; LENALIDOMIDE; CHEMOTHERAPY;

D O I：

10.1111/bjh.13994

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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 11years, 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=053) nor overall survival (OS) (P=033) 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=061) or OS (P=016). In the ITT and PP set of the tandem arm, the rates of complete responses increased from first to second HDM/ASCT (both P=004). 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=004). In this study single HDM/ASCT was non-inferior to tandem HDM/ASCT in MM.

引用

页码：731 / 741

页数：11

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