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Straka, Christian; Liebisch, Peter; Salwender, Hans; Hennemann, Burkhard; Metzner, Bernd; Knop, Stefan; Adler-Reichel, Sigrid; Gerecke, Christian; Wandt, Hannes; Bentz, Martin; Bruemmendorf, Tim Hendrik; Hentrich, Marcus; Pfreundschuh, Michael; Wolf, Hans-Heinrich; Sezer, Orhan; Bargou, Ralf; Jung, Wolfram; Truemper, Lorenz; Hertenstein, Bernd; Heidemann, Else; Bernhard, Helga; Lang, Nicola; Frickhofen, Norbert; Hebart, Holger; Schmidmaier, Ralf; Sandermann, Andreas; Dechow, Tobias; Reichle, Albrecht; Schnabel, Brigitte; Schäfer-Eckart, Kerstin; Langer, Christian; Gramatzki, Martin; Hinke, Axel; Emmerich, Bertold; Einsele, Hermann (2016): Autotransplant with and without induction chemotherapy in older multiple myeloma patients: long-term outcome of a randomized trial. In: Haematologica, Vol. 101, No. 11: pp. 1398-1406
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Abstract

Autologous transplantation is controversial for older patients with multiple myeloma. The role of age-adjusted high-dose melphalan and the impact of induction chemotherapy cycles is still unclear. A total of 434 patients aged 60-70 years were randomly assigned to 4 cycles of standard anthracycline-based induction chemotherapy or no induction. For all patients, double autologous transplantation after melphalan 140 mg/m(2) (MEL140) was planned. The primary end point was progression-free survival. Of 420 eligible patients, 85% received a first transplant and 69% completed double transplantation. Treatment duration was short with a median of 7.7 months with induction chemotherapy cycles and 4.6 months without induction. On an intention-to-treat basis, median progression-free survival with induction chemotherapy cycles (207 patients) was 21.4 months versus 20.0 months with no induction cycles (213 patients) (hazard ratio 1.04, 95% confidence interval 0.84-1.28;P= 0.36). Per protocol, progression-free survival was 23.7 months versus 23.0 months (P= 0.28). Patients aged 65 years or over (55%) did not have an inferior outcome. Patients with low-risk cytogenetics [absence of del17p13, t(4;14) and 1q21 gains] showed a favorable overall survival and included the patients with sustained first remission. MEL140 was associated with a low rate of severe mucositis (10%) and treatment-related deaths (1%). Based on hazard ratio, the short treatment arm consisting of mobilization chemotherapy and tandem MEL140 achieved 96% of the progression-free survival, demonstrating its value as an independent component of therapy in older patients with multiple myeloma who are considered fit for autologous transplantation.