7aea1b2001283a13a7fcc84563b60625 290595.pdf ef467e973b12f24b592d15880a17dd5420ed140c 290595.pdf 0b45161c7d554c4100d06288f3e509112c3259f619a4466c9c1c7bea4bbf3006 290595.pdf Title: Complications of Autologous Stem Cell Transplantation in Multiple Myeloma: Results from the CALM Study Subject: Background: The main goal of this post hoc analysis of the Collaboration to Collect Autologous Transplant Outcomes in Lymphoma and Myeloma (CALM) study was to evaluate the rate of short- and long-term infectious and non-infectious complications occurring after ASCT in patients with multiple myeloma (MM). Methods: The analysis included all patients with MM from the CALM study who underwent 1 ASCT. The primary endpoint of the analysis was to determine the rate of infectious and non-infectious complications after ASCT and to compare them in three time periods: 0–100 days, 101 days–1 year, and >1 year after the first transplant. Results: The analysis included a total of 3552 patients followed up for a median of 56.7 months (range 0.4–108.1). Complication rates decreased with the time from ASCT with 24.85 cases per 100 patient-years from day 0 to 100 days after the transplant, and <2.31 cases per 100 patient-years from the 101st day. At 100 days after ASC T, 45.7% of patients had complications, with infectious events being twice as frequent as non-infectious complications. Bacterial infections (6.5 cases per 100 patient-years, 95% CI: 6.1–7.0) and gastrointestinal complications (4.7 cases per 100 patient-years, 95% CI: 4.3–5.1) were the most common early events. The pattern of complications changed with time from ASCT. The presence of complications after ASCT was not associated with overall survival. Conclusions: Our data provide a solid basis for comparing ASCT-related complications to those caused by emerging treatments in multiple myeloma, such as CAR T-cell therapy and other immunotherapies. Keywords: autologous stem cell transplantation in multiple myeloma; complications; multiple myeloma Author: Anna Waszczuk-Gajda, Olaf Penack, Giulia Sbianchi, Linda Koster, Didier Blaise, Péter Reményi, Nigel Russell, Per Ljungman, Marek Trneny, Jiri Mayer, Simona Iacobelli, Guido Kobbe, Christof Scheid, Jane Apperley, Cyrille Touzeau, Stig Lenhoff, Esa Jantunen, Achilles Anagnostopoulos, Laura Paris, Paul Browne, Catherine Thieblemont, Nicolaas Schaap, Jorge Sierra, Ibrahim Yakoub-Agha, Laurent Garderet, Jan Styczynski, Helene Schoemans, Ivan Moiseev, Rafael F. Duarte, Zinaida Peric, Silvia Montoto, Anja van Biezen, Malgorzata Mikulska, Mahmoud Aljurf, Tapani Ruutu, Nicolaus Kröger, Curly Morris, Christian Koenecke, Stefan Schoenland and Grzegorz W. 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Duarte, Zinaida Peric, Silvia Montoto, Anja van Biezen, Malgorzata Mikulska, Mahmoud Aljurf, Tapani Ruutu, Nicolaus Kröger, Curly Morris, Christian Koenecke, Stefan Schoenland and Grzegorz W. Basak Subject: Background: The main goal of this post hoc analysis of the Collaboration to Collect Autologous Transplant Outcomes in Lymphoma and Myeloma (CALM) study was to evaluate the rate of short- and long-term infectious and non-infectious complications occurring after ASCT in patients with multiple myeloma (MM). Methods: The analysis included all patients with MM from the CALM study who underwent 1 ASCT. The primary endpoint of the analysis was to determine the rate of infectious and non-infectious complications after ASCT and to compare them in three time periods: 0 100 days, 101 days 1 year, and >1 year after the first transplant. Results: The analysis included a total of 3552 patients followed up for a median of 56.7 months (range 0.4 108.1). Complication rates decreased with the time from ASCT with 24.85 cases per 100 patient-years from day 0 to 100 days after the transplant, and <2.31 cases per 100 patient-years from the 101st day. At 100 days after ASC T, 45.7% of patients had complications, with infectious events being twice as frequent as non-infectious complications. Bacterial infections (6.5 cases per 100 patient-years, 95% CI: 6.1 7.0) and gastrointestinal complications (4.7 cases per 100 patient-years, 95% CI: 4.3 5.1) were the most common early events. The pattern of complications changed with time from ASCT. The presence of complications after ASCT was not associated with overall survival. Conclusions: Our data provide a solid basis for comparing ASCT-related complications to those caused by emerging treatments in multiple myeloma, such as CAR T-cell therapy and other immunotherapies. 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