Autologous-allogeneic versus autologous tandem stem cell transplantation and maintenance therapy with thalidomide for multiple myeloma patients under 60 years of age: a prospective phase II study
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Autologous-allogeneic versus autologous tandem stem cell transplantation and maintenance therapy with thalidomide for multiple myeloma patients under 60 years of age: a prospective phase II study. / Kröger, Nicolaus; Wulf, Gerald; Hegenbart, Ute; Burchert, Andreas; Stelljes, Matthias; Gagelmann, Nico; Brecht, Arne; Kaufmann, Martin; Müller, Lutz; Ganser, Arnold; Wolf, Dominik; Bethge, Wolfgang; Bornhäuser, Martin; Kiehl, Michael; Wagner, Eva-Maria; Schmid, Christoph; Reinhardt, Hans Christian; Kobbe, Guido; Salwender, Hans; Heinicke, Thomas; Kropff, Martin; Heinzelmann, Marion; Ayuk, Francis; Trümper, Lorenz; Neubauer, Andreas; Völp, Andreas; Kluychnikov, Evgeny; Schönland, Stefan; Wolschke, Christine.
In: HAEMATOLOGICA, Vol. 109, No. 5, 01.05.2024, p. 1469-1479.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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TY - JOUR
T1 - Autologous-allogeneic versus autologous tandem stem cell transplantation and maintenance therapy with thalidomide for multiple myeloma patients under 60 years of age: a prospective phase II study
AU - Kröger, Nicolaus
AU - Wulf, Gerald
AU - Hegenbart, Ute
AU - Burchert, Andreas
AU - Stelljes, Matthias
AU - Gagelmann, Nico
AU - Brecht, Arne
AU - Kaufmann, Martin
AU - Müller, Lutz
AU - Ganser, Arnold
AU - Wolf, Dominik
AU - Bethge, Wolfgang
AU - Bornhäuser, Martin
AU - Kiehl, Michael
AU - Wagner, Eva-Maria
AU - Schmid, Christoph
AU - Reinhardt, Hans Christian
AU - Kobbe, Guido
AU - Salwender, Hans
AU - Heinicke, Thomas
AU - Kropff, Martin
AU - Heinzelmann, Marion
AU - Ayuk, Francis
AU - Trümper, Lorenz
AU - Neubauer, Andreas
AU - Völp, Andreas
AU - Kluychnikov, Evgeny
AU - Schönland, Stefan
AU - Wolschke, Christine
PY - 2024/5/1
Y1 - 2024/5/1
N2 - 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).
AB - 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).
U2 - 10.3324/haematol.2023.282920
DO - 10.3324/haematol.2023.282920
M3 - SCORING: Journal article
C2 - 37941409
VL - 109
SP - 1469
EP - 1479
JO - HAEMATOLOGICA
JF - HAEMATOLOGICA
SN - 0390-6078
IS - 5
ER -
