Autologous-allogeneic <i>versus</i> autologous tandem stem cell transplantation and maintenance therapy with thalidomide for multiple myeloma patients under 60 years of age: a prospective, phase II study
Nicolaus Kröger,
Gerald Wulf,
Ute Hegenbart,
Andreas Burchert,
Matthias Stelljes,
Nico Gagelmann,
Arne Brecht,
Martin Kaufmann,
Lutz Müller,
Arnold Ganser,
Dominik Wolf,
Wolfgang Bethge,
Martin Bornhäuser,
Michael Kiehl,
Eva-Maria Wagner,
Christoph Schmid,
Hans Christian Reinhardt,
Guido Kobbe,
Hans Salwender,
Thomas Heinicke,
Martin Kropff,
Marion Heinzelmann,
Francis Ayuk,
Lorenz Trümper,
Andreas Neubauer,
Andreas Völp,
Evgeny Kluychnikov,
Stefan Schönland,
Christine Wolschke
Affiliations
Nicolaus Kröger
University Medical Center Hamburg
Gerald Wulf
University Hospital Göttingen
Ute Hegenbart
University Hospital Heidelberg
Andreas Burchert
University Hospital Marburg
Matthias Stelljes
Department of Medicine A, Hematology, Oncology, and Pneumology, University Hospital Münster
Nico Gagelmann
University Medical Center Hamburg
Arne Brecht
DKD HELIOS Hospital Wiesbaden, Germany, and HELIOS Dr. Horst Schmidt Hospitals Wiesbaden
Martin Kaufmann
Robert Bosch Hospital, Stuttgart
Lutz Müller
University Hospital Halle
Arnold Ganser
Medical School Hannover
Dominik Wolf
Internal Medicine 3, University Hospital Bonn, Germany and Depart. Hematology and Oncology, Comprehensive Cancer Center Innsbruck (CCCI), Medical University Innsbruck (MUI), Innsbruck
The role of autologous-allogeneic tandem stem cell transplantation (alloTSCT) followed by maintenance as upfront treatment for multiple myeloma is controversial. Between 2008 and 2014 a total of 217 multiple myeloma patients with a median age of 51 years were included by 20 German centers within an open-label, parallel-group, multicenter clinical trial to compare alloTSCT to autologous tandem transplantation (autoTSCT) followed by 2 years of maintenance therapy with thalidomide (100 mg/day) in both arms with respect to relapse/progression-free survival (PFS) and other relevant outcomes. A total of 178 patients underwent a second transplant (132 allogeneic, 46 autologous). PFS at 4 years after the second transplant was 47% (95% CI: 38-55%) for alloTSCT and 35% (95% CI: 21-49%) for autoTSCT (P=0.26). This difference increased to 22% at 8 years (P=0.10). The cumulative incidences of non-relapse mortality and of relapse at 4 years were 13% (95% CI: 8-20%) and 2% (95% CI: 0.3-2%) (P=0.044) and 40% (95% CI: 33-50%) and 63% (95% CI: 50-79%) (P=0.04) for alloTSCT and autoTSCT, respectively. The difference for relapse/progression increased to 33% (alloTSCT: 44%, autoTSCT: 77%) at a median follow-up of 82 months (P=0.002). Four-year overall survival was 66% (95% CI: 57-73%) for alloTSCT and 66% (95% CI: 50-78%) for autoTSCT (P=0.91) and 8-year overall survival was 52% and 50% (P=0.87), respectively. In conclusion, alloTSCT followed by thalidomide maintenance reduced the rate of recurrence or progression during a follow-up period of up to 10 years but failed to improve PFS significantly. This study was registered with ClinicalTrials.gov (NCT00777998).
