Salvage autologous transplant in relapsed multiple myeloma: long-term follow-up of the phase 3 GMMG ReLApsE trial
Abstract
Abstract The multicenter, phase 3 German-Speaking Myeloma Multicenter Group (GMMG) ReLApsE trial randomized patients with relapsed and/or refractory multiple myeloma (RRMM) equally to lenalidomide/dexamethasone (LEN/DEX; 25 mg days 1-21, DEX 40 mg weekly, in 4-week cycles) reinduction, salvage high-dose chemotherapy (sHDCT; melphalan 200 mg/m2), autologous stem cell transplantation (ASCT), and LEN maintenance (10 mg/d; transplant arm, n = 139) vs continuous LEN/DEX (control arm, n = 138). Ninety-four percent of patients had received frontline HDCT/ASCT. We report an updated analysis of survival end points with a median follow-up of 99 months. Median progression-free survival (PFS) was 20.5 and 19.3 months in the transplant and control arm, respectively (hazard ratio [HR], 0.98; P = .9). Median overall survival (OS) was 67.1 and 62.7 months, respectively, (HR 0.89; P = .44). Landmark analyses from sHDCT and the contemporaneous LEN/DEX cycle 5 were performed because of 29% dropout of patients before sHDCT/ASCT in the transplant arm but did not reveal significant differences in PFS/OS. Time to progression after frontline HDCT/ASCT was a prognostic factor but did not predict benefit from sHDCT/ASCT. The GMMG ReLApsE trial does not support use of sHDCT/ASCT in RRMM after frontline HDCT/ASCT. This trial was registered at www.clinicaltrialsregister.eu as #EudraCT2009-013856-61.
Article Details
Authors (27)
Marc-Andrea Baertsch
1Heidelberg Myeloma Center, Department of Internal Medicine V, Heidelberg University Hospital, Medical Faculty, Heidelberg University, Heidelberg, Germany
Jana Schlenzka
1Heidelberg Myeloma Center and GMMG Study Group, Department of Medicine V, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg, Germany
Thomas Hielscher
Marc S. Raab
Sandra Sauer
Maximilian Merz
11Myeloma Service, Memorial Sloan Kettering Cancer Center, New York, NY
Elias Karl Mai
1Heidelberg Myeloma Center and GMMG Study Group, Department of Medicine V, Heidelberg University Hospital and Medical Faculty Heidelberg, Heidelberg, Germany
Carsten Müller-Tidow
Steffen Luntz
15Coordination Centre for Clinical Trials (KKS) Heidelberg, Heidelberg, Germany
Anna Jauch
Peter Brossart
Martin Goerner
9Department of Hematology, Oncology and Palliative Care, Community Hospital Bielefeld, Bielefeld, Germany
Stefan Klein
Bertram Glass
21Department of Hematology and Cell Therapy Helios Klinikum Berlin-Buch, Berlin, Germany
Peter Reimer
22Evang. Kliniken Essen-Mitte, Clinic for Hematology, Oncology and Stem Cell Transplantation, Essen, Germany
Ullrich Graeven
Roland Fenk
4University Hospital Düsseldorf, Department of Hematology, Oncology and Clinical Immunology, Düsseldorf, Germany
Mathias Haenel
15Department of Hematology, Oncology and Stem Cell Transplantation, Klinikum Chemnitz GmbH, Chemnitz, Germany
Ivana von Metzler
Hans W. Lindemann
17Department of Hematology and Oncology, Katholisches Krankenhaus Hagen gem. GmbH, Hagen, Germany
Christof Scheid
12Hospital Barmherzige Brueder Regensburg, Clinic for Oncology and Hematology, Regensburg, Germany
Igor-Wolfgang Blau
19Internal Medicine III, Charité Campus Benjamin Franklin, Berlin, Germany
Hans J. Salwender
20Asklepios Tumorzentrum Hamburg, AK Altona and AK St. Georg, Hamburg, Germany
Richard Noppeney
11Division of Hematology/Oncology, Medizinische Klinik I, Krankenhaus der Barmherzigen Brüder, Trier, Germany
Britta Besemer
Department of Internal Medicine II, University Tübingen, Tübingen, Germany
Katja C. Weisel
Hartmut Goldschmidt
Internal Medicine V, Hematology, Oncology and Rheumatology, German-Speaking Myeloma Multicenter Group Study Group, Heidelberg University Hospital and National Center for Tumor Diseases, Heidelberg, Germany