Phase II Trial of Allogeneic Transplantation Plus Novel Drugs in Multiple Myeloma : Effect of Intensifying Reduced-Intensity Conditioning with Bortezomib and Adding Maintenance Treatment
Reinoso-Segura, Marta (Universidad de Sevilla)
Caballero Velazquez, Teresa (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Herrera, Pilar (Hospital Universitario Ramón y Cajal (Madrid))
Patriarca, Francesca (University Hospital and DAME)
Fanin, Renato (University Hospital and DAME)
Bruno, Benedetto (AOU Città della Salute e della Scienza di Torino)
Einsele, Hermann (Medizinische Klinik and Poliklinik II University Hospital)
Nahi, Hareth (Karolinska University Hospital and Karolinska Institutet (Suècia))
Granell, Miquel (Institut d'Investigació Biomèdica Sant Pau)
López-Corral, Lucía (Centro de Investigación del Cáncer-IBMCC)
Reguera, Juan L. (Universidad de Sevilla)
Garcia Cadenas, Irene (Institut d'Investigació Biomèdica Sant Pau)
Gahrton, Gösta (European Society for Blood and Marrow Transplantation)
Pérez-Simón, José A. (Universidad de Sevilla)
Universitat Autònoma de Barcelona

Data:	2022
Resum:	The use of reduced-intensity conditioning (RIC) regimens has decreased the risk of nonrelapse mortality (NRM) after allogeneic stem cell transplantation (alloSCT). In contrast, disease relapse remains the most frequent cause of treatment failure and death. Owing to both their antimyeloma effect and immunomodulatory properties, novel drugs could improve outcomes after alloSCT. This phase II European Myeloma Network trial was designed to evaluate the combination of alloSCT with novel agents. The study was conducted to evaluate the toxicity and efficacy of RIC intensified with bortezomib (Bz) prior to alloSCT for high-risk (HR) multiple myeloma (MM) patients, as well as the efficacy of post-transplantation maintenance with Bz and lenalidomide (Len). Patients received RIC with Bz on days -9 and -2, fludarabine on days -6 to -4, and melphalan on day -3. Patients who were in complete response (CR) or near CR at day +100 post-transplantation received 6 cycles of Bz every 56 days, and the remaining received Bz, Len, and dexamethasone. Len maintenance was started on day +180 at a dose of 5 mg and continued until relapse or toxicity occurred. Of the 24 patients included, 21 were evaluable on day +100, including 12 in CR, 4 in very good partial response, 3 in partial response, and 2 with relapse or progression. The cumulative incidence (CuI) of relapse was 13. 6% (95% confidence interval [CI], 3. 2% to 31. 3%) at 1 year and 28. 5% (95% CI, 11. 1% to 48. 9%) at 2 years. The CuI of NRM was 21. 1% (95% CI, 7. 4% to 39. 4%) at 2 years. With a median follow-up of 39 months (range, 1 to 67 months), the median event-free survival (EFS) was 29 months, and median overall survival (OS) was not reached. EFS and OS at 3 years were 42. 5% (95% CI, 21. 9% to 61. 7%) and 74. 01% (95% CI, 50. 9% to 87. 5%), respectively. The use of Bz within an RIC regimen allows for a high response rate after alloSCT. Maintenance with Bz and Len is feasible and provides remarkable results in terms of EFS and OS in HR MM patients.
Ajuts:	Ministerio de Economía y Competitividad CB16/12/00480 Ministerio de Economía y Competitividad CB16/12/00233
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Allogeneic stem cell transplantation ; Bortezomib ; Lenalidomide maintenance ; Multiple myeloma ; Reduced-intensity conditioning
Publicat a:	Transplantation and cellular therapy, Vol. 28 Núm. 5 (may 2022) , p. 258.e1-258.e8, ISSN 2666-6367

DOI: 10.1016/j.jtct.2022.01.026
PMID: 35131486

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