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10 results on '"Crippa C."'

1. Bortezomib with thalidomide plus dexamethasone compared with thalidomide plus dexamethasone as induction therapy before, and consolidation therapy after, double autologous stem-cell transplantation in newly diagnosed multiple myeloma: a randomised phase 3 study

Author

Cavo, M, Tacchetti, P, Patriarca, F, Petrucci, Mt, Pantani, L, Galli, M, Di Raimondo, F, Crippa, C, Zamagni, E, Palumbo, Antonio, Offidani, M, Corradini, P, Narni, F, Spadano, A, Pescosta, N, Deliliers, Gl, Ledda, A, Cellini, C, Caravita, T, Tosi, P, Baccarani, M, GIMEMA Italian Myeloma Network, Aglietta, Massimo, Cavo M, Tacchetti P, Patriarca F, Petrucci MT, Pantani L, Galli M, Di Raimondo F, Crippa C, Zamagni E, Palumbo A, Offidani M, Corradini P, Narni F, Spadano A, Pescosta N, Deliliers GL, Ledda A, Cellini C, Caravita T, Tosi P, and Baccarani M

Subjects
Male, stem-cell, Kaplan-Meier Estimate, autologous, Dexamethasone, Bortezomib, Autologous stem-cell transplantation, Antineoplastic Combined Chemotherapy Protocols, Adjuvant, Multiple myeloma, Antibacterial agent, Medicine (all), Remission Induction, Hematopoietic Stem Cell Transplantation, thalidomide, transplantation, myeloma, General Medicine, Middle Aged, Boronic Acids, Neoadjuvant Therapy, Thalidomide, Treatment Outcome, Italy, Chemotherapy, Adjuvant, Adult, Aged, Disease-Free Survival, Drug Administration Schedule, Female, Humans, Multiple Myeloma, Pyrazines, Reoperation, Transplantation, Autologous, Autologous, medicine.drug, medicine.medical_specialty, Internal medicine, medicine, Chemotherapy, Transplantation, Intention-to-treat analysis, business.industry, medicine.disease, Surgery, business, dexamethasone, multiple myeloma
Abstract

Thalidomide plus dexamethasone (TD) is a standard induction therapy for myeloma. We aimed to assess the efficacy and safety of addition of bortezomib to TD (VTD) versus TD alone as induction therapy before, and consolidation therapy after, double autologous stem-cell transplantation in newly diagnosed multiple myeloma.Patients (aged 18-65 years) with previously untreated symptomatic myeloma were enrolled from 73 sites in Italy between May, 2006, and April, 2008, and data collection continued until June 30, 2010. Patients were randomly allocated (1:1 ratio) by a web-based system to receive three 21-day cycles of thalidomide (100 mg daily for the first 14 days and 200 mg daily thereafter) plus dexamethasone (40 mg daily on 8 of the first 12 days, but not consecutively; total of 320 mg per cycle), either alone or with bortezomib (1·3 mg/m(2) on days 1, 4, 8, and 11). The randomisation sequence was computer generated by the study coordinating team and was stratified by disease stage. After double autologous stem-cell transplantation, patients received two 35-day cycles of their assigned drug regimen, VTD or TD, as consolidation therapy. The primary endpoint was the rate of complete or near complete response to induction therapy. Analysis was by intention to treat. Patients and treating physicians were not masked to treatment allocation. This study is still underway but is not recruiting participants, and is registered with ClinicalTrials.gov, number NCT01134484, and with EudraCT, number 2005-003723-39.480 patients were enrolled and randomly assigned to receive VTD (n=241 patients) or TD (n=239). Six patients withdrew consent before start of treatment, and 236 on VTD and 238 on TD were included in the intention-to-treat analysis. After induction therapy, complete or near complete response was achieved in 73 patients (31%, 95% CI 25·0-36·8) receiving VTD, and 27 (11%, 7·3-15·4) on TD (p0·0001). Grade 3 or 4 adverse events were recorded in a significantly higher number of patients on VTD (n=132, 56%) than in those on TD (n=79, 33%; p0·0001), with a higher occurrence of peripheral neuropathy in patients on VTD (n=23, 10%) than in those on TD (n=5, 2%; p=0·0004). Resolution or improvement of severe peripheral neuropathy was recorded in 18 of 23 patients on VTD, and in three of five patients on TD.VTD induction therapy before double autologous stem-cell transplantation significantly improves rate of complete or near complete response, and represents a new standard of care for patients with multiple myeloma who are eligible for transplant.Seràgnoli Institute of Haematology at the University of Bologna, Bologna, Italy.

Published
2010

2. Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma: a report from the GIMEMA--Italian Multiple Myeloma Network

Author

Palumbo, Antonio, Falco, P, Corradini, P, Falcone, A, DI RAIMONDO, F, Giuliani, N, Crippa, C, Ciccone, G, Omedè, P, Ambrosini, Mt, Gay, F, Bringhen, S, Musto, P, Foà, R, Knight, R, Zeldis, Jb, Boccadoro, Mario, Petrucci, Mt, and GIMEMA ITALIAN MULTIPLE MYELOMA NETWORK

Subjects
Male, Melphalan, Cancer Research, medicine.medical_specialty, Drug-Related Side Effects and Adverse Reactions, Maximum Tolerated Dose, medicine.drug_class, Administration, Oral, Gastroenterology, chemistry.chemical_compound, Maintenance therapy, Prednisone, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Lenalidomide, Multiple myeloma, Aged, Dose-Response Relationship, Drug, business.industry, Middle Aged, medicine.disease, Survival Analysis, Nitrogen mustard, Thalidomide, Surgery, Oncology, chemistry, Corticosteroid, Female, Multiple Myeloma, business, medicine.drug
Abstract

Purpose Lenalidomide has shown significant antimyeloma activity in clinical studies. Oral melphalan, prednisone, and thalidomide have been regarded as the standard of care in elderly multiple myeloma patients. We assessed dosing, efficacy, and safety of melphalan, prednisone, and lenalidomide (MPR) in newly diagnosed elderly myeloma patients. Patients and Methods Oral melphalan was administered in doses ranging from 0.18 to 0.25 mg/kg on days 1 to 4, prednisone at a 2-mg/kg dose on days 1 to 4, and lenalidomide at doses ranging from 5 to 10 mg on days 1 to 21, every 28 days for nine cycles, followed by maintenance therapy with lenalidomide alone. Aspirin was given as a prophylaxis for thrombosis. Results Fifty-four patients were enrolled and evaluated after completing the assigned treatment schedule. The maximum tolerated dose was defined as 0.18 mg/kg melphalan and 10 mg lenalidomide. With these doses, 81% of patients achieved at least a partial response, 47.6% achieved a very good partial response, and 23.8% achieved a complete immunofixation-negative response. In all patients, 1-year event-free and overall survival rates were 92% and 100%, respectively. At the maximum tolerated dose, grade 3 adverse events included neutropenia (38.1%), thrombocytopenia (14.2%), febrile neutropenia (9.5%), vasculitis (9.5%), and thromboembolism (4.8%); grade 4 adverse events were neutropenia (14.2%) and thrombocytopenia (9.5%). Conclusion Oral MPR therapy is a promising first-line treatment for elderly myeloma patients. Hematologic adverse events were frequent but manageable. A low incidence of nonhematologic adverse events was noted. Aspirin appears to provide adequate antithrombosis prophylaxis.

Published
2007

3. Skip pattern approach toward the early access of innovative anticancer drugs

Author

R. Luksch, Giulio Rossi, F. de Braud, Pierfranco Conte, Matteo Duca, F. Perrone, Claudia Cardone, Stefania Gori, F. Lussana, Diego Signorelli, Alessandro Inno, Andrea Ardizzoni, Michele Maio, Andrea Biondi, Paolo Verderio, G. Gritti, C. Crippa, Chiara Maura Ciniselli, G. Soverini, Giuliano Buzzetti, Giovanni Apolone, Alessandro Rambaldi, M.M. Valente, A. Bortolami, Giulia Pasello, Apolone, G, Ardizzoni, A, Biondi, A, Bortolami, A, Cardone, C, Ciniselli, C, Conte, P, Crippa, C, de Braud, F, Duca, M, Gori, S, Gritti, G, Inno, A, Luksch, R, Lussana, F, Maio, M, Pasello, G, Perrone, F, Rambaldi, A, Rossi, G, Signorelli, D, Soverini, G, Valente, M, Verderio, P, Buzzetti, G, Apolone, G., Ardizzoni, A., Biondi, A., Bortolami, A., Cardone, C., Ciniselli, C.M., Conte, P., Crippa, C., de Braud, F., Duca, M., Gori, S., Gritti, G., Inno, A., Luksch, R., Lussana, F., Maio, M., Pasello, G., Perrone, F., Rambaldi, A., Rossi, G., Signorelli, D., Soverini, G., Valente, M., Verderio, P., and Buzzetti, G.

Subjects
Cancer Research, early access priority, Process (engineering), unmet medical need, Antineoplastic Agents, Regulatory authority, Government Agencies, Neoplasms, Agency (sociology), Humans, Medicine, Generalizability theory, Original Research, quality of evidence, business.industry, early access priority innovative anticancer treatments unmet medical need added benefit quality of evidence, innovative anticancer treatment, Quality of evidence, Italy, Oncology, Risk analysis (engineering), Scale (social sciences), innovative anticancer treatments, Clinical value, business, added benefit
Abstract

Background With the rapid development of innovative anticancer treatments, the optimization of tools able to accelerate the access of new drugs to the market by the regulatory authority is a major issue. The aim of the project was to propose a reliable methodological pathway for the assessment of clinical value of new therapeutic innovative options, to objectively identify drugs which deserve early access (EA) priority for solid and possibly in other cancer scenarios, such as the hematological ones. Materials and methods After a comprehensive review of the European Public Assessment Report of 21 drugs, to which innovation had previously been attributed by the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA), an expert panel formulated an algorithm for the balanced use of three parameters: Unmet Medical Need (UMN) according to AIFA criteria, Added Benefit (AB) according to the European Society for Medical Oncology’s Magnitude of Clinical Benefit Scale (ESMO-MCBS) criteria and Quality of Evidence (QE) assessed by the Grades of Recommendation Assessment, Development and Evaluation (GRADE) method. By sequentially combining the above indicators, a final priority status (i.e. EA or not) was obtained using the skip pattern approach (SPA). Results By applying the SPA to the non-curative setting in solid cancers, the EA status was obtained by 5 out of 14 investigated drugs (36%); by enhancing the role of some categories of the UMN, additional 4 drugs, for a total of 9 (64%), reached the EA status: 2 and 3 drugs were excluded for not achieving an adequate score according to AB and QE criteria, respectively. For hematology cancer, only the UMN criteria were found to be adequate. Conclusions The use of this model may represent a reliable tool for assessment available to the various stakeholders involved in the EA process and may help regulatory agencies in a more comprehensive and objective definition of new treatments’ value in these contexts. Its generalizability in other national contexts needs further evaluation., Highlights • Optimize the access of new innovative drugs to the Italian market. • Methodological tool for new drug’s priority status assessment partially based on that used by the AIFA. • An SPA has been carried out based on three dimensions: UMN, AB and QE.

Published
2021

4. The novel Mechanical Ventilator Milano for the COVID-19 pandemic

Author

M. Tardocchi, P. Lu, Silvia Bonfanti, C. Fricbergs, J. M. Cela Ruiz, M. Del Tutto, R. Brown, D. Salomoni, C. Jillings, A. Visioli, A. Abba, B. Smith, P. Stringari, Valerio Ippolito, K. Olchanski, S. Yue, A. Razeto, L. Parmeggiano, M. Beschi, I. Palumbo, C. C. James, M. Daley, Andrea Bombarda, Eugenio Scapparone, T. Boccali, D. Vonica, G. Luzón, E. Panontin, Nigel Hessey, E. Elliott, O. Putignano, R. Maharaj, M. H. L. S. Wang, M. Laclaustra, A. Sher, E. Gramellini, P. Napoli, S. Parmeggiano, E. Meazzi, S. Sala, A. Muraro, T. Girma, D. Trask, A. Lennarz, F. Golf, G. Magni, C. Di Guardo, A. S. Slutsky, C. Lim, B. Shaw, C. Duma, V. Pesudo, S. Gillespie, A. Devoto, E. Guetre, L. Camozzi, B. Bell, C. E. Dahl, M. Dossi, E. Alessi, M. MacDonald, A. J. Noble, F. Ardellier Desages, O. Davignon, B. Morrison, R. D. Fournier, Alberto Annovi, S. Kuula, Elvinia Riccobene, A. Rizzi, G. Hersak, J. Bagger, S. Brice, S. Khan, L. VanPagee, P. Salvo, R. Lubna, A. Bayo, M. Bouchard, J. Romualdez, G. Bianchi, H. Wang, S. Bicelli, T. A. Mohayai, A. Dal Molin, M. Breviario, C. Ienzi, M. Carlini, K. Hayashi, G. Monzani, G. A. Lukhanin, R. J. Ford, D. Yates, B. Velghe, G. Finocchiaro, C. Charette, M.H. Kushoro, E. Sansoucy, D. Reed, Pierre-Andre Amaudruz, A. Pocar, S. Scorza, M. Camozzi, T. Reilly, C. Crippa, S. Pordes, F. Padula, S. Westerdale, C. Straubel, P. Garcia Abia, A. Shi, D. Giorgi, A. Capra, S. Shawyer, S. Martin, F. Prelz, S. Back, D. Sablone, L. Takeuchi, D. Franco, L. Martin, An. Ianni, L. Tseng, P. McClurg, M. I. Martínez, D. Wood, A. Norrick, C. Pellegrino, J. Tseng, C. Ratti, M. Constable, V. Vedia, L. M. Tosatti, L. S. Giarratana, G. Fiorillo, M. Razeti, A. Patel, C. R. Natzke, S. Manni, M. Wada, S. Tacchino, M. Paterno, P. Gorel, P. Diaz Gomez Maqueo, N. Massacret, S. Cudmore, Marco Pallavicini, A. Heavey, Gabriele Croci, E. Kim, B. Celano, G. Batignani, E. Druszkiewicz, A. L. Renshaw, L. Giacomelli, D. Walter, S. Viel, Angelo Gargantini, D. Goeldi, P. Liimatainen, N. J. T. Smith, T. Schaubel, G. Cogliati, G. Foti, C. Mapelli, F. Retriere, Giuseppe Gorini, K. Patel, R. Tartaglia, N. Papini, M. Settimo, P. Pelliccione, P. Skensved, M. Leyton, V. Basile, A. Kittmer, G. D'Avenio, D. Rigamonti, R. Krücken, F. Guescini, F. Giacomini, E. Thomas, K. Hudson, Claudio Moretti, R. Santorelli, G. Hackman, R. Gobui, L. Viviani, C. Savarese, I. Kochanek, R. Migalla, J. Rode, F. Gabriele, D. Farina, F. Ferroni, F. Di Francesco, J. M. Calvo-Mozota, M. Suchenek, G. Hockin, J. Refsgaard, J. Kowalkowski, A. Pope, T. Lomonaco, S. King, Bhaskar Sur, C. L. Kendziora, M. Caravati, A. Ceccanti, W. Hawkins, W. Bonivento, C. Fernandes, G. Leblond, M. Mountaniol, A. B. McDonald, C. Accorsi, A. Stenzler, Federico Nati, V. Zambrano, D. Bishop, M. King, A. Sandoval, X. Li, P. Margetak, P. Agnes, J. L. Raaf, J. De Ruiter, Cristiano Galbiati, Giovanni Grosso, L. Lee, A. Ortiz de Solórzano, T. Hadden, T. Lindner, D. Biagini, L. Russel, C. Badia, Abba, A., Accorsi, C., Agnes, P., Alessi, E., Amaudruz, P., Annovi, A., Desages, F. A., Back, S., Badia, C., Bagger, J., Basile, V., Batignani, G., Bayo, A., Bell, B., Beschi, M., Biagini, D., Bianchi, G., Bicelli, S., Bishop, D., Boccali, T., Bombarda, A., Bonfanti, S., Bonivento, W. M., Bouchard, M., Breviario, M., Brice, S., Brown, R., Calvo-Mozota, J. M., Camozzi, L., Camozzi, M., Capra, A., Caravati, M., Carlini, M., Ceccanti, A., Celano, B., Cela Ruiz, J. M., Charette, C., Cogliati, G., Constable, M., Crippa, C., Croci, G., Cudmore, S., Dahl, C. E., Dal Molin, A., Daley, M., Di Guardo, C., D'Avenio, G., Davignon, O., Del Tutto, M., De Ruiter, J., Devoto, A., Diaz Gomez Maqueo, P., Di Francesco, F., Dossi, M., Druszkiewicz, E., Duma, C., Elliott, E., Farina, D., Fernandes, C., Ferroni, F., Finocchiaro, G., Fiorillo, G., Ford, R., Foti, G., Fournier, R. D., Franco, D., Fricbergs, C., Gabriele, F., Galbiati, C., Garcia Abia, P., Gargantini, A., Giacomelli, L., Giacomini, F., Giarratana, L. S., Gillespie, S., Giorgi, D., Girma, T., Gobui, R., Goeldi, D., Golf, F., Gorel, P., Gorini, G., Gramellini, E., Grosso, G., Guescini, F., Guetre, E., Hackman, G., Hadden, T., Hawkins, W., Hayashi, K., Heavey, A., Hersak, G., Hessey, N., Hockin, G., Hudson, K., Ianni, A., Ienzi, C., Ippolito, V., James, C. C., Jillings, C., Kendziora, C., Khan, S., Kim, E., King, M., King, S., Kittmer, A., Kochanek, I., Kowalkowski, J., Krucken, R., Kushoro, M., Kuula, S., Laclaustra, M., Leblond, G., Lee, L., Lennarz, A., Leyton, M., Li, X., Liimatainen, P., Lim, C., Lindner, T., Lomonaco, T., Lu, P., Lubna, R., Lukhanin, G. A., Luzon, G., Macdonald, M., Magni, G., Maharaj, R., Manni, S., Mapelli, C., Margetak, P., Martin, L., Martin, S., Martinez, M., Massacret, N., Mcclurg, P., Mcdonald, A. B., Meazzi, E., Migalla, R., Mohayai, T., Tosatti, L. M., Monzani, G., Moretti, C., Morrison, B., Mountaniol, M., Muraro, A., Napoli, P., Nati, F., Natzke, C. R., Noble, A. J., Norrick, A., Olchanski, K., Ortiz De Solorzano, A., Padula, F., Pallavicini, M., Palumbo, I., Panontin, E., Papini, N., Parmeggiano, L., Parmeggiano, S., Patel, K., Patel, A., Paterno, M., Pellegrino, C., Pelliccione, P., Pesudo, V., Pocar, A., Pope, A., Pordes, S., Prelz, F., Putignano, O., Raaf, J. L., Ratti, C., Razeti, M., Razeto, A., Reed, D., Refsgaard, J., Reilly, T., Renshaw, A., Retriere, F., Riccobene, E., Rigamonti, D., Rizzi, A., Rode, J., Romualdez, J., Russel, L., Sablone, D., Sala, S., Salomoni, D., Salvo, P., Sandoval, A., Sansoucy, E., Santorelli, R., Savarese, C., Scapparone, E., Schaubel, T., Scorza, S., Settimo, M., Shaw, B., Shawyer, S., Sher, A., Shi, A., Skensved, P., Slutsky, A., Smith, B., Smith, N. J. T., Stenzler, A., Straubel, C., Stringari, P., Suchenek, M., Sur, B., Tacchino, S., Takeuchi, L., Tardocchi, M., Tartaglia, R., Thomas, E., Trask, D., Tseng, J., Tseng, L., Vanpagee, L., Vedia, V., Velghe, B., Viel, S., Visioli, A., Viviani, L., Vonica, D., Wada, M., Walter, D., Wang, H., Wang, M. H. L. S., Westerdale, S., Wood, D., Yates, D., Yue, S., Zambrano, V., AstroParticule et Cosmologie (APC (UMR_7164)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-Observatoire de Paris, Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP), Laboratoire Leprince-Ringuet (LLR), Centre National de la Recherche Scientifique (CNRS)-École polytechnique (X)-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3), Laboratoire de Physique Nucléaire et de Hautes Énergies (LPNHE (UMR_7585)), Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS)-Université de Paris (UP), Laboratoire de physique subatomique et des technologies associées (SUBATECH), Université de Nantes - UFR des Sciences et des Techniques (UN UFR ST), Université de Nantes (UN)-Université de Nantes (UN)-Centre National de la Recherche Scientifique (CNRS)-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-IMT Atlantique Bretagne-Pays de la Loire (IMT Atlantique), Institut Mines-Télécom [Paris] (IMT)-Institut Mines-Télécom [Paris] (IMT), École des Mines de Paris, Université Paris sciences et lettres (PSL)-Université Paris sciences et lettres (PSL)-Centre National de la Recherche Scientifique (CNRS)-Université Paris Cité (UPCité), Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-École polytechnique (X)-Centre National de la Recherche Scientifique (CNRS), Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-Sorbonne Université (SU)-Centre National de la Recherche Scientifique (CNRS), Université de Nantes (UN)-Université de Nantes (UN)-Institut National de Physique Nucléaire et de Physique des Particules du CNRS (IN2P3)-Centre National de la Recherche Scientifique (CNRS)-IMT Atlantique (IMT Atlantique), Abba, A, Accorsi, C, Agnes, P, Alessi, E, Amaudruz, P, Annovi, A, Desages, F, Back, S, Badia, C, Bagger, J, Basile, V, Batignani, G, Bayo, A, Bell, B, Beschi, M, Biagini, D, Bianchi, G, Bicelli, S, Bishop, D, Boccali, T, Bombarda, A, Bonfanti, S, Bonivento, W, Bouchard, M, Breviario, M, Brice, S, Brown, R, Calvo-Mozota, J, Camozzi, L, Camozzi, M, Capra, A, Caravati, M, Carlini, M, Ceccanti, A, Celano, B, Cela Ruiz, J, Charette, C, Cogliati, G, Constable, M, Crippa, C, Croci, G, Cudmore, S, Dahl, C, Dal Molin, A, Daley, M, Di Guardo, C, D'Avenio, G, Davignon, O, Del Tutto, M, De Ruiter, J, Devoto, A, Diaz Gomez Maqueo, P, Di Francesco, F, Dossi, M, Druszkiewicz, E, Duma, C, Elliott, E, Farina, D, Fernandes, C, Ferroni, F, Finocchiaro, G, Fiorillo, G, Ford, R, Foti, G, Fournier, R, Franco, D, Fricbergs, C, Gabriele, F, Galbiati, C, Garcia Abia, P, Gargantini, A, Giacomelli, L, Giacomini, F, Giarratana, L, Gillespie, S, Giorgi, D, Girma, T, Gobui, R, Goeldi, D, Golf, F, Gorel, P, Gorini, G, Gramellini, E, Grosso, G, Guescini, F, Guetre, E, Hackman, G, Hadden, T, Hawkins, W, Hayashi, K, Heavey, A, Hersak, G, Hessey, N, Hockin, G, Hudson, K, Ianni, A, Ienzi, C, Ippolito, V, James, C, Jillings, C, Kendziora, C, Khan, S, Kim, E, King, M, King, S, Kittmer, A, Kochanek, I, Kowalkowski, J, Krucken, R, Kushoro, M, Kuula, S, Laclaustra, M, Leblond, G, Lee, L, Lennarz, A, Leyton, M, Li, X, Liimatainen, P, Lim, C, Lindner, T, Lomonaco, T, Lu, P, Lubna, R, Lukhanin, G, Luzon, G, Macdonald, M, Magni, G, Maharaj, R, Manni, S, Mapelli, C, Margetak, P, Martin, L, Martin, S, Martinez, M, Massacret, N, Mcclurg, P, Mcdonald, A, Meazzi, E, Migalla, R, Mohayai, T, Tosatti, L, Monzani, G, Moretti, C, Morrison, B, Mountaniol, M, Muraro, A, Napoli, P, Nati, F, Natzke, C, Noble, A, Norrick, A, Olchanski, K, Ortiz De Solorzano, A, Padula, F, Pallavicini, M, Palumbo, I, Panontin, E, Papini, N, Parmeggiano, L, Parmeggiano, S, Patel, K, Patel, A, Paterno, M, Pellegrino, C, Pelliccione, P, Pesudo, V, Pocar, A, Pope, A, Pordes, S, Prelz, F, Putignano, O, Raaf, J, Ratti, C, Razeti, M, Razeto, A, Reed, D, Refsgaard, J, Reilly, T, Renshaw, A, Retriere, F, Riccobene, E, Rigamonti, D, Rizzi, A, Rode, J, Romualdez, J, Russel, L, Sablone, D, Sala, S, Salomoni, D, Salvo, P, Sandoval, A, Sansoucy, E, Santorelli, R, Savarese, C, Scapparone, E, Schaubel, T, Scorza, S, Settimo, M, Shaw, B, Shawyer, S, Sher, A, Shi, A, Skensved, P, Slutsky, A, Smith, B, Smith, N, Stenzler, A, Straubel, C, Stringari, P, Suchenek, M, Sur, B, Tacchino, S, Takeuchi, L, Tardocchi, M, Tartaglia, R, Thomas, E, Trask, D, Tseng, J, Tseng, L, Vanpagee, L, Vedia, V, Velghe, B, Viel, S, Visioli, A, Viviani, L, Vonica, D, Wada, M, Walter, D, Wang, H, Wang, M, Westerdale, S, Wood, D, Yates, D, Yue, S, and Zambrano, V

Subjects
ventilator, Emergency Use Authorization, Coronavirus disease 2019 (COVID-19), Fault conditions, Computational Mechanics, Certification, 01 natural sciences, 010305 fluids & plasmas, law.invention, Mechanical parts, Food and drug administration, Compressed oxygen, Food and Drug Administration, Health care professionals, Industrial partners, Intensive therapy, Ventilation mode, Mechanical ventilator, law, 0103 physical sciences, Pandemic, medicine, 010306 general physics, Fluid Flow and Transfer Processes, Physics, [PHYS]Physics [physics], Mechanical Engineering, healthcare, Articles, Condensed Matter Physics, medicine.disease, 3. Good health, Medical gas supply, Mechanical Ventilation, COVID-19 Pandemic, covid-19, Mechanics of Materials, Others, Ventilation (architecture), Medical emergency, Settore ING-INF/05 - Sistemi di Elaborazione delle Informazioni, [PHYS.ASTR]Physics [physics]/Astrophysics [astro-ph]
Abstract

International audience; This paper presents the Mechanical Ventilator Milano (MVM), a novel intensive therapy mechanical ventilator designed for rapid, large-scale, low-cost production for the COVID-19 pandemic. Free of moving mechanical parts and requiring only a source of compressed oxygen and medical air to operate, the MVM is designed to support the long-term invasive ventilation often required for COVID-19 patients and operates in pressure-regulated ventilation modes, which minimize the risk of furthering lung trauma. The MVM was extensively tested against ISO standards in the laboratory using a breathing simulator, with good agreement between input and measured breathing parameters and performing correctly in response to fault conditions and stability tests. The MVM has obtained Emergency Use Authorization by U.S. Food and Drug Administration (FDA) for use in healthcare settings during the COVID-19 pandemic and Health Canada Medical Device Authorization for Importation or Sale, under Interim Order for Use in Relation to COVID-19. Following these certifications, mass production is ongoing and distribution is under way in several countries. The MVM was designed, tested, prepared for certification, and mass produced in the space of a few months by a unique collaboration of respiratory healthcare professionals and experimental physicists, working with industrial partners, and is an excellent ventilator candidate for this pandemic anywhere in the world

Published
2021

5. Bortezomib-thalidomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy following autologous hematopoietic stem-cell transplantation in patients with newly diagnosed multiple myeloma

Author

Cavo, Michele, Pantani, Lucia, Petrucci, Maria Teresa, Patriarca, Francesca, Zamagni, Elena, Donnarumma, Daniela, Crippa, Claudia, Boccadoro, Mario, Perrone, Giulia, Falcone, Antonietta, Nozzoli, Chiara, Zambello, Renato, Masini, Luciano, Furlan, Anna, Brioli, Annamaria, Derudas, Daniele, Ballanti, Stelvio, Dessanti, Maria Laura, De Stefano, Valerio, Carella, Angelo Michele, Marcatti, Magda, Nozza, Andrea, Ferrara, Felicetto, Callea, Vincenzo, Califano, Catello, Pezzi, Annalisa, Baraldi, Anna, Grasso, Mariella, Musto, Pellegrino, Palumbo, Antonio COLLABORATORI: Tosi, P, Motta, Mr, Rizzi, S, Fanin, R, Buttignol, S, Foà, R, Levi, A, Calabrese, E, Rambaldi, A, Galli, M, Rossi, G, Ferrari, S, Bringhen, S, Leoni, P, Offidani, M, Polloni, C, Corradini, P, Montefusco, V, Torelli, G, Narni, Franco, Fioritoni, G, Spadano, A, Cortelazzo, S, Pescosta, N, Billio, A, Lambertenghi Deliliers, G, Baldini, L, Onida, F, Annaloro, C, La Nasa, G, Ledda, A, Zaccaria, A, Cellini, C, De Fabritiis, P, Caravita, T, Siniscalchi, A, Cascavilla, N, Bosi, A, Semenzato, G, Gugliotta, L, Merli, F, Gherlinzoni, F, Angelucci, E, Martelli, M, Petti, Mc, Pisani, F, Leone, G, Rossi, E, Za, T, Fianchi, L, Catania, G, Spriano, M, Ciceri, F, Peccatori, J, Girlanda, S, Santoro, A, Castagna, L, Palmieri, S, Nobile, F, D'Arco, Am, Levis, A, Primon, V, Tamiazzo, S, Guardigni, L, Pasini, S, Gallamini, A, Pietrantuono, G, Martorelli, Mc, Fattori, P, Pasquini, E, Galieni, P, Ruggieri, M, Morandi, S, Tajana, M, Amadori, D, Ronconi, S, Cangini, D, Ceccolini, M, Gobbi, M, Ballerini, F, Pane, F, Catalano, L, Cangialosi, C, Vallisa, D, Lazzaro, A, Paladini, G, De Sabbata, G, Mozzana, R, Ciambelli, F, Pinotti, G, Rodeghiero, F, Elice, F, Cantore, N, Volpe, S, Pavone, V, Mele, A, Pogliani, E, Rossini, F, Liberati, A, Majolino, I, De Rosa, L, Amadori, S, Rizzo, M, Lauria, F, Gozzetti, A, Aglietta, M, Capaldi, A, Quarta, G, Mele, G, Storti, S, Fraticelli, V, Morabito, F, Gentile, C, Capalbo, S, Gianni, A, Magni, M, Mettivier, V, Nunziata, G, Rizzoli, V, Giuliani, N, Crugnola, M, Bernasconi, C, Fregoni, V, Visani, G, Olivieri, A, Pizzuti, M, La Verde, G, Moscetti, A, Avvisati, G, Tirindelli, M, Longinotti, M, Podda, L, Gallo, E, Pregno, P, Dammacco, F, Perosa, F, Russo, D, Roccaro, A, Bacigalupo, A, Dominietto, A, Musolino, C, Quartarone, E., Cavo M, Pantani L, Petrucci MT, Patriarca F, Zamagni E, Donnarumma D, Crippa C, Boccadoro M, Perrone G, Falcone A, Nozzoli C, Zambello R, Masini L, Furlan A, Brioli A, Derudas D, Ballanti S, Dessanti ML, De Stefano V, Carella AM, Marcatti M, Nozza A, Ferrara F, Callea V, Califano C, Pezzi A, Baraldi A, Grasso M, Musto P, Palumbo A., Cavo, Michele, Pantani, Lucia, Petrucci, Maria Teresa, Patriarca, Francesca, Zamagni, Elena, Donnarumma, Daniela, Crippa, Claudia, Boccadoro, Mario, Perrone, Giulia, Falcone, Antonietta, Nozzoli, Chiara, Zambello, Renato, Masini, Luciano, Furlan, Anna, Brioli, Annamaria, Derudas, Daniele, Ballanti, Stelvio, Dessanti, Maria Laura, De Stefano, Valerio, Carella, Angelo Michele, Marcatti, Magda, Nozza, Andrea, Ferrara, Felicetto, Callea, Vincenzo, Califano, Catello, Pezzi, Annalisa, Baraldi, Anna, Grasso, Mariella, Musto, Pellegrino, Palumbo, Antonio, Cavo, M, Pantani, L, Petrucci, M, Patriarca, F, Zamagni, E, Donnarumma, D, Crippa, C, Boccadoro, M, Perrone, G, Falcone, A, Nozzoli, C, Zambello, R, Masini, L, Furlan, A, Brioli, A, Derudas, D, Ballanti, S, Dessanti, M, De Stefano, V, Carella, A, Marcatti, M, Nozza, A, Ferrara, F, Callea, V, Califano, C, Pezzi, A, Baraldi, A, Grasso, M, Musto, P, Palumbo, A, Tosi, P, Motta, M, Rizzi, S, Fanin, R, Buttignol, S, Foà, R, Levi, A, Calabrese, E, Rambaldi, A, Galli, M, Rossi, G, Ferrari, S, Bringhen, S, Leoni, P, Offidani, M, Polloni, C, Corradini, P, Montefusco, V, Torelli, G, Narni, F, Fioritoni, G, Spadano, A, Cortelazzo, S, Pescosta, N, Billio, A, Lambertenghi Deliliers, G, Baldini, L, Onida, F, Annaloro, C, La Nasa, G, Ledda, A, Zaccaria, A, Cellini, C, De Fabritiis, P, Caravita, T, Siniscalchi, A, Cascavilla, N, Bosi, A, Semenzato, G, Gugliotta, L, Merli, F, Gherlinzoni, F, Angelucci, E, Martelli, M, Petti, M, Pisani, F, Leone, G, Rossi, E, Za, T, Fianchi, L, Catania, G, Spriano, M, Ciceri, F, Peccatori, J, Girlanda, S, Santoro, A, Castagna, L, Palmieri, S, Nobile, F, D'Arco, A, Levis, A, Primon, V, Tamiazzo, S, Guardigni, L, Pasini, S, Gallamini, A, Pietrantuono, G, Martorelli, M, Fattori, P, Pasquini, E, Galieni, P, Ruggieri, M, Morandi, S, Tajana, M, Amadori, D, Ronconi, S, Cangini, D, Ceccolini, M, Gobbi, M, Ballerini, F, Pane, F, Catalano, L, Cangialosi, C, Vallisa, D, Lazzaro, A, Paladini, G, De Sabbata, G, Mozzana, R, Ciambelli, F, Pinotti, G, Rodeghiero, F, Elice, F, Cantore, N, Volpe, S, Pavone, V, Mele, A, Pogliani, E, Rossini, F, Liberati, A, Majolino, I, De Rosa, L, Amadori, S, Rizzo, M, Lauria, F, Gozzetti, A, Aglietta, M, Capaldi, A, Quarta, G, Mele, G, Storti, S, Fraticelli, V, Morabito, F, Gentile, C, Capalbo, S, Gianni, A, Magni, M, Mettivier, V, Nunziata, G, Rizzoli, V, Giuliani, N, Crugnola, M, Bernasconi, C, Fregoni, V, Visani, G, Olivieri, A, Pizzuti, M, La Verde, G, Moscetti, A, Avvisati, G, Tirindelli, M, Longinotti, M, Podda, L, Gallo, E, Pregno, P, Dammacco, F, Perosa, F, Russo, D, Roccaro, A, Bacigalupo, A, Dominietto, A, Musolino, C, and Quartarone, E

Subjects
Male, Boronic Acid, medicine.medical_treatment, PLUS DEXAMETHASONE, Phases of clinical research, Kaplan-Meier Estimate, Hematopoietic stem cell transplantation, Biochemistry, Antineoplastic Agent, Bortezomib-thalidomide-dexamethasone, Bortezomib, Immunosuppressive Agent, Autologous stem-cell transplantation, MULTIPLE MYELOMA, Antineoplastic Combined Chemotherapy Protocols, thalidomide-dexamethasone, Multiple myeloma, RANDOMIZED PHASE-3, LENALIDOMIDE, STEM CELL TRANSPLANTATION, Hematopoietic Stem Cell Transplantation, PHASE-III TRIAL, Hematology, Middle Aged, CHEMOTHERAPY, Prognosis, Boronic Acids, Combined Modality Therapy, Thalidomide, Transplantation, Autologou, Pyrazines, HIGH-DOSE MELPHALAN, INDUCTION TREATMENT, Female, Autologous, Immunosuppressive Agents, Pyrazine, Human, medicine.drug, MAINTENANCE THERAPY, medicine.medical_specialty, DOXORUBICIN, Antineoplastic Agents, Hormonal, Prognosi, Immunology, Urology, Antineoplastic Agents, dexamethasone, Transplantation, Autologous, Disease-Free Survival, Dexamethasone, Humans, Multiple Myeloma, Cell Biology, medicine, Autologous transplantation, METAANALYSIS, Transplantation, Antineoplastic Combined Chemotherapy Protocol, Hormonal, business.industry, medicine.disease, Surgery, business, Settore MED/15 - Malattie del Sangue
Abstract

In a randomized, phase 3 study, superior complete/near-complete response (CR/nCR) rates and extended progression-free survival were demonstrated with bortezomib-thalidomide-dexamethasone (VTD) versus thalidomide-dexamethasone (TD) as induction therapy before, and consolidation after, double autologous stem cell transplantation for newly diagnosed myeloma patients (intention-to-treat analysis; VTD, n = 236; TD, n = 238). This per-protocol analysis (VTD, n = 160; TD, n = 161) specifically assessed the efficacy and safety of consolidation with VTD or TD. Before starting consolidation, CR/nCR rates were not significantly different in the VTD (63.1%) and TD arms (54.7%). After consolidation, CR (60.6% vs 46.6%) and CR/nCR (73.1% vs 60.9%) rates were significantly higher for VTD-treated versus TD-treated patients. VTD consolidation significantly increased CR and CR/nCR rates, but TD did not (McNemar test). With a median follow-up of 30.4 months from start of consolidation, 3-year progression-free survival was significantly longer for the VTD group (60% vs 48% for TD). Grade 2 or 3 peripheral neuropathy (8.1% vs 2.4%) was more frequent with VTD (grade 3, 0.6%) versus TD consolidation. The superior efficacy of VTD versus TD as induction was retained despite readministration as consolidation therapy after double autologous transplantation. VTD consolidation therapy significantly contributed to improved clinical outcomes observed for patients randomly assigned to the VTD arm of the study. The study is registered at www.clinicaltrials.gov as #NCT01134484.

Published
2012

6. Bortezomib, thalidomide, and dexamethasone followed by double autologous haematopoietic stem-cell transplantation for newly diagnosed multiple myeloma (GIMEMA-MMY-3006): long-term follow-up analysis of a randomised phase 3, open-label study

Author

Paola Tacchetti, Lucia Pantani, Francesca Patriarca, Maria Teresa Petrucci, Elena Zamagni, Luca Dozza, Monica Galli, Francesco Di Raimondo, Claudia Crippa, Mario Boccadoro, Simona Barbato, Patrizia Tosi, Franco Narni, Vittorio Montefusco, Nicoletta Testoni, Antonio Spadano, Carolina Terragna, Norbert Pescosta, Giulia Marzocchi, Claudia Cellini, Piero Galieni, Sonia Ronconi, Marco Gobbi, Lucio Catalano, Antonio Lazzaro, Giovanni De Sabbata, Clotilde Cangialosi, Fabrizio Ciambelli, Pellegrino Musto, Francesca Elice, Michele Cavo, Renato Fanin, Roberto Foa', Alessandro Rambaldi, Giuseppe Rossi, Pietro Leoni, Paolo Corradini, Giuseppe Torelli, Giuseppe Fioritoni, Sergio Cortelazzo, Giorgio Lambertenghi Deliliers, Giorgio La Nasa, Alfonso Zaccaria, Paolo De Fabritiis, Nicola Cascavilla, Alberto Bosi, Gianpietro Semenzato, Luigi Gugliotta, Filippo Gherlinzoni, Emanuele Angelucci, Massimo Fabrizio Martelli, Maria Concetta Petti, Giuseppe Leone, Angelo Michele Carella, Fabio Ciceri, Armando Santoro, Felicetto Ferrara, Francesco Nobile, Alfonso Maria D'Arco, Alessandro Levis, Luciano Guardigni, Andrea Gallamini, Pier Paolo Fattori, Sergio Morandi, Dino Amadori, Bruno Rotoli, Salvatore Mirto, Giorgio Paladini, Ruggero Mozzana, Graziella Pinotti, Francesco Rodeghiero, Nicola Cantore, Vincenzo Pavone, Enrico Maria Pogliani, Anna Marina Liberati, Ignazio Majolino, Sergio Amadori, Francesco Lauria, Massimo Aglietta, Giovanni Quarta, Sergio Storti, Fortunato Morabito, Silvana Franca Capalbo, Alessandro Massimo Gianni, Vincenzo Mettivier, Vittorio Rizzoli, Carlo Bernasconi, Giuseppe Visani, Michele Pizzuti, Giacinto La Verde, Giuseppe Avvisati, Maurizio Longinotti, Eugenio Gallo, Franco Dammacco, Domenico Russo, Andrea Bacigalupo, Caterina Musolino, Tacchetti P., Pantani L., Patriarca F., Petrucci M.T., Zamagni E., Dozza L., Galli M., Di Raimondo F., Crippa C., Boccadoro M., Barbato S., Tosi P., Narni F., Montefusco V., Testoni N., Spadano A., Terragna C., Pescosta N., Marzocchi G., Cellini C., Galieni P., Ronconi S., Gobbi M., Catalano L., Lazzaro A., De Sabbata G., Cangialosi C., Ciambelli F., Musto P., Elice F., Cavo M., Fanin R., Foa' R., Rambaldi A., Rossi G., Leoni P., Corradini P., Torelli G., Fioritoni G., Cortelazzo S., Lambertenghi Deliliers G., La Nasa G., Zaccaria A., De Fabritiis P., Cascavilla N., Bosi A., Semenzato G., Gugliotta L., Gherlinzoni F., Angelucci E., Martelli M.F., Petti M.C., Leone G., Carella A.M., Ciceri F., Santoro A., Ferrara F., Nobile F., D'Arco A.M., Levis A., Guardigni L., Gallamini A., Fattori P.P., Morandi S., Amadori D., Rotoli B., Mirto S., Paladini G., Mozzana R., Pinotti G., Rodeghiero F., Cantore N., Pavone V., Pogliani E.M., Liberati A.M., Majolino I., Amadori S., Lauria F., Aglietta M., Quarta G., Storti S., Morabito F., Capalbo S.F., Gianni A.M., Mettivier V., Rizzoli V., Bernasconi C., Visani G., Pizzuti M., La Verde G., Avvisati G., Longinotti M., Gallo E., Dammacco F., Russo D., Bacigalupo A., and Musolino C.

Subjects
Adult, Male, medicine.medical_specialty, Transplantation Conditioning, Adolescent, Phases of clinical research, Transplantation, Autologous, Dexamethasone, Bortezomib, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, GIMEMA-MMY-3006 trial, bortezomib, thalidomide, dexamethasone, VTD, double autologous haematopoietic stem-cell transplantation, multiple myeloma, Multiple myeloma, Aged, Intention-to-treat analysis, business.industry, Hazard ratio, Hematopoietic Stem Cell Transplantation, Hematology, Middle Aged, medicine.disease, Thalidomide, Transplantation, Regimen, 030220 oncology & carcinogenesis, Female, Multiple Myeloma, business, Follow-Up Studies, 030215 immunology, medicine.drug
Abstract

Background: The phase 3 GIMEMA-MMY-3006 trial, which compared bortezomib, thalidomide, and dexamethasone (VTD) combination therapy with thalidomide and dexamethasone (TD) as induction therapy before and consolidation therapy after double autologous haematopoietic stem-cell transplantation (HSCT) for newly diagnosed multiple myeloma, showed the superiority of the triplet regimen over the doublet in terms of increased complete response rate and improved progression-free survival. We report the results from the final analysis of the study. Methods: In this randomised, open-label, phase 3 study, patients aged 18–65 years with previously untreated symptomatic multiple myeloma and a Karnofsky Performance Status of 60% or higher were enrolled at 73 centres in Italy. Patients were randomised (1:1) by a web-based system to receive three 21-day cycles of thalidomide (100 mg daily orally for the first 14 days and 200 mg daily thereafter) plus dexamethasone (total 320 mg per cycle; 40 mg on days 1–2, 4–5, 8–9, and 11–12 in the VTD regimen, and 40 mg on days 1–4 and 9–12 in the TD regimen), either alone (TD group) or with bortezomib (1·3 mg/m2 intravenously on days 1, 4, 8, and 11; VTD group). After double autologous HSCT, patients received two 35-day cycles of either the VTD or TD regimen, according to random assignment, as consolidation therapy. The primary outcome was the rate of complete response and near complete response after induction (already reported). In this updated analysis we assessed long-term progression-free survival and overall survival (secondary endpoints of the study) with an extended 10-year median follow-up, and analysed the variables influencing survival. Analysis was by intention to treat. The study is registered with ClinicalTrials.gov, NCT01134484. Findings: Between May 10, 2006, and April 30, 2008, 480 patients were enrolled and randomly assigned to receive VTD (241 patients) or TD (239 patients). Six patients withdrew consent before start of treatment. 236 (99 [42%] women) in the VTD group and 238 (102 [43%] women) in the TD group were included in the intention-to-treat analysis. The data cutoff date for this analysis was May 31, 2018. Median follow-up for surviving patients was 124·1 months (IQR 117·2–131·7). The 10-year progression-free survival estimate for patients in the VTD group was 34% (95% CI 28–41) compared with 17% (13–23) for the TD group (hazard ratio [HR] 0·62 [95% CI 0·50–0·77]; p

Published
2020

7. COVID-19 and stem cell transplantation; results from an EBMT and GETH multicenter prospective survey

Author

Carlos Vallejo Llamas, Mohsen Al Zahrani, Per Ljungman, Kim Orchard, María J. Jiménez, María Calbacho, Beatriz Aguado, Jose Luis Lopez Lorenzo, Safiye Koçulu Demir, Rafael de la Cámara, Aliénor Xhaard, Rocio Parody Porras, Maria Laura Fox, Rodrigo Martino Bofarull, Daniele Vallisa, José Luis Piñana, Gloria Tridello, Mi Kwon, Angel Cedillo, Anna De Grassi, Nina Knelange, Jane F. Apperley, Malgorzata Mikulska, Jan Styczyński, Stephan Mielke, Nicolaus Kröger, Lucía López-Corral, Fabio Ciceri, Claudia Crippa, Ana Berceanu, National Institute for Health Research (UK), Ljungman, P., de la Camara, R., Mikulska, M., Tridello, G., Aguado, B., Zahrani, M. A., Apperley, J., Berceanu, A., Bofarull, R. M., Calbacho, M., Ciceri, F., Lopez-Corral, L., Crippa, C., Fox, M. L., Grassi, A., Jimenez, M. -J., Demir, S. K., Kwon, M., Llamas, C. V., Lorenzo, J. L. L., Mielke, S., Orchard, K., Porras, R. P., Vallisa, D., Xhaard, A., Knelange, N. S., Cedillo, A., Kroger, N., Pinana, J. L., Styczynski, J., Institut Català de la Salut, [Ljungman P] Department of Cellular Therapy and Allogeneic Stem Cell Transplantation, Karolinska Comprehensive Cancer Center, Karolinska University Hospital Huddinge, Stockholm, Sweden. Division of Hematology, Department of Medicine Huddinge, Karolinska Institutet, Stockholm, Sweden. [de la Camara R] Department of Hematology, Hospital de la Princesa, Madrid, Spain. [Mikulska M] Division of Infectious Diseases, University of Genoa and Ospedale Policlinico San Martino, Genova, Italy. [Tridello G] Pediatric Hematology Oncology, Verona, Italy. [Aguado B] Department of Hematology, Hospital de la Princesa, Madrid, Spain. [Zahrani MA] King Abdul – Aziz Medical City, Riyadh, Saudi Arabia. [Fox ML] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Experimental Hematology Group, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Investigative Techniques::Epidemiologic Methods::Data Collection::Surveys and Questionnaires [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Male, Cancer Research, medicine.medical_treatment, Hematopoietic stem cell transplantation, Stem cells, virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Medicine, Prospective Studies, Young adult, Prospective cohort study, Child, Immunodeficiency, COVID-19 (Malaltia) - Complicacions, Aged, 80 and over, Hematopoietic Stem Cell Transplantation, Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], Immunosuppression, Hematology, Middle Aged, Prognosis, Survival Rate, Oncology, Child, Preschool, Hematologic Neoplasms, Infectious diseases, Female, Cèl·lules mare, terapéutica::terapia biológica::tratamientos basados en células y tejidos::trasplante de células::trasplante de células madre::trasplante de células madre hematopoyéticas [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Haematological diseases, Adult, medicine.medical_specialty, Adolescent, Article, Young Adult, Internal medicine, Mortalitat, Humans, Transplantation, Homologous, Mortality, Survival rate, Aged, Performance status, Cèl·lules mare hematopoètiques - Trasplantació, business.industry, SARS-CoV-2, Infant, COVID-19, técnicas de investigación::métodos epidemiológicos::recopilación de datos::encuestas y cuestionarios [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], medicine.disease, Transplantation, Sang - Malalties, Therapeutics::Biological Therapy::Cell- and Tissue-Based Therapy::Cell Transplantation::Stem Cell Transplantation::Hematopoietic Stem Cell Transplantation [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], business, Follow-Up Studies
Abstract

© The Author(s) 2021., This study reports on 382 COVID-19 patients having undergone allogeneic (n = 236) or autologous (n = 146) hematopoietic cell transplantation (HCT) reported to the European Society for Blood and Marrow Transplantation (EBMT) or to the Spanish Group of Hematopoietic Stem Cell Transplantation (GETH). The median age was 54.1 years (1.0–80.3) for allogeneic, and 60.6 years (7.7–81.6) for autologous HCT patients. The median time from HCT to COVID-19 was 15.8 months (0.2–292.7) in allogeneic and 24.6 months (−0.9 to 350.3) in autologous recipients. 83.5% developed lower respiratory tract disease and 22.5% were admitted to an ICU. Overall survival at 6 weeks from diagnosis was 77.9% and 72.1% in allogeneic and autologous recipients, respectively. Children had a survival of 93.4%. In multivariate analysis, older age (p = 0.02), need for ICU (p < 0.0001) and moderate/high immunodeficiency index (p = 0.04) increased the risk while better performance status (p = 0.001) decreased the risk for mortality. Other factors such as underlying diagnosis, time from HCT, GVHD, or ongoing immunosuppression did not significantly impact overall survival. We conclude that HCT patients are at high risk of developing LRTD, require admission to ICU, and have increased mortality in COVID-19., JA acknowledges the support of the UK NIHR Imperial College Biomedical Research Centre.

Published
2021

8. Aspirin, Warfarin, or Enoxaparin Thromboprophylaxis in Patients With Multiple Myeloma Treated With Thalidomide: A Phase III, Open-Label, Randomized Trial

Author

Claudia Crippa, Alessandra Romano, Michele Cavo, Francesca Elice, Roberto Marasca, Mario Boccadoro, Massimo Offidani, Renato Zambello, Claudia Cellini, Valeria Magarotto, Vincenzo Callea, Monica Galli, Claudia Polloni, Patrizia Tosi, Angelo Michele Carella, Giulia Benevolo, Elena Zamagni, Andrea Evangelista, Fabiana Gentilini, Stefano Pulini, Antonio Palumbo, Vittorio Montefusco, Sara Bringhen, Chiara Nozzoli, Davide Rossi, Norbert Pescosta, Roberto Ria, Paola Tacchetti, Francesca Patriarca, Luca Baldini, Tommaso Caravita, Fortunato Morabito, Palumbo A., Cavo M., Bringhen S., Zamagni E., Romano A., Patriarca F., Rossi D., Gentilini F., Crippa C., Galli M., Nozzoli C., Ria R., Marasca R., Montefusco V., Baldini L., Elice F., Callea V., Pulini S., Carella A.M., Zambello R., Benevolo G., Magarotto V., Tacchetti P., Pescosta N., Cellini C., Polloni C., Evangelista A., Caravita T., Morabito F., Offidani M., Tosi P., and Boccadoro M.

Subjects
Male, Cancer Research, medicine.medical_specialty, Time Factors, multiple myeloma, thrombosis, prophylaxis, medicine.drug_class, Low molecular weight heparin, Antineoplastic Agents, Hemorrhage, Risk Assessment, Sudden death, Fibrinolytic Agents, MULTIPLE MYELOMA, Risk Factors, Thromboembolism, Internal medicine, Multicenter trial, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Enoxaparin, THROMBOPROPHYLAXIS, Contraindication, Aged, wafarin, Aspirin, business.industry, Warfarin, Anticoagulants, Middle Aged, Thalidomide, Surgery, ASPIRIN, Treatment Outcome, Italy, Oncology, Cardiovascular Diseases, Female, business, Enoxaparin sodium, Platelet Aggregation Inhibitors, medicine.drug
Abstract

Purpose In patients with myeloma, thalidomide significantly improves outcomes but increases the risk of thromboembolic events. In this randomized, open-label, multicenter trial, we compared aspirin (ASA) or fixed low-dose warfarin (WAR) versus low molecular weight heparin (LMWH) for preventing thromboembolism in patients with myeloma treated with thalidomide-based regimens. Patients and Methods A total of 667 patients with previously untreated myeloma who received thalidomide-containing regimens and had no clinical indication or contraindication for a specific antiplatelet or anticoagulant therapy were randomly assigned to receive ASA (100 mg/d), WAR (1.25 mg/d), or LMWH (enoxaparin 40 mg/d). A composite primary end point included serious thromboembolic events, acute cardiovascular events, or sudden deaths during the first 6 months of treatment. Results Of 659 analyzed patients, 43 (6.5%) had serious thromboembolic events, acute cardiovascular events, or sudden death during the first 6 months (6.4% in the ASA group, 8.2% in the WAR group, and 5.0% in the LMWH group). Compared with LMWH, the absolute differences were +1.3% (95% CI, −3.0% to 5.7%; P = .544) in the ASA group and +3.2% (95% CI, −1.5% to 7.8%; P = .183) in the WAR group. The risk of thromboembolism was 1.38 times higher in patients treated with thalidomide without bortezomib. Three major (0.5%) and 10 minor (1.5%) bleeding episodes were recorded. Conclusion In patients with myeloma treated with thalidomide-based regimens, ASA and WAR showed similar efficacy in reducing serious thromboembolic events, acute cardiovascular events, and sudden deaths compared with LMWH, except in elderly patients where WAR showed less efficacy than LMWH.

Published
2011

9. Autologous transplantation and maintenance therapy in multiple myeloma

Author

Antonio Palumbo, Federica Cavallo, Francesca Gay, Francesco Di Raimondo, Dina Ben Yehuda, Maria Teresa Petrucci, Sara Pezzatti, Tommaso Caravita, Chiara Cerrato, Elena Ribakovsky, Mariella Genuardi, Anna Cafro, Magda Marcatti, Lucio Catalano, Massimo Offidani, Angelo Michele Carella, Elena Zamagni, Francesca Patriarca, Pellegrino Musto, Andrea Evangelista, Giovannino Ciccone, Paola Omedé, Claudia Crippa, Paolo Corradini, Arnon Nagler, Mario Boccadoro, Michele Cavo, Palumbo, A, Cavallo, F, Gay, F, Di Raimondo, F, Ben Yehuda, D, Petrucci, Mt, Pezzatti, S, Caravita, T, Cerrato, C, Ribakovsky, E, Genuardi, M, Cafro, A, Marcatti, M, Catalano, L, Offidani, M, Carella, Am, Zamagni, E, Patriarca, F, Musto, P, Evangelista, A, Ciccone, G, Omedé, P, Crippa, C, Corradini, P, Nagler, A, Boccadoro, M, and Cavo, M.

Subjects
Adult, Melphalan, PREDNISONE, medicine.medical_specialty, Neutropenia, PLUS DEXAMETHASONE, BORTEZOMIB, Kaplan-Meier Estimate, Transplantation, Autologous, Disease-Free Survival, Maintenance Chemotherapy, Maintenance therapy, Antineoplastic Combined Chemotherapy Protocols, Humans, Medicine, Combined Modality Therapy, Autologous transplantation, Antineoplastic Agents, Alkylating, ELDERLY-PATIENTS, Multiple myeloma, Aged, Lenalidomide, LENALIDOMIDE, Autologous transplantation, multiple myeloma, business.industry, Hazard ratio, STEM-CELL TRANSPLANTATION, General Medicine, Middle Aged, RANDOMIZED CONTROLLED-TRIAL, medicine.disease, INDUCTION THERAPY, Thalidomide, Surgery, Consolidation Chemotherapy, Transplantation, INITIAL TREATMENT, MELPHALAN, Multiple Myeloma, business, Stem Cell Transplantation, medicine.drug
Abstract

BACKGROUND: This open-label, randomized, phase 3 study compared melphalan at a dose of 200 mg per square meter of body-surface area plus autologous stem-cell transplantation with melphalan-prednisone-lenalidomide (MPR) and compared lenalidomide maintenance therapy with no maintenance therapy in patients with newly diagnosed multiple myeloma. METHODS: We randomly assigned 273 patients 65 years of age or younger to high-dose melphalan plus stem-cell transplantation or MPR consolidation therapy after induction, and 251 patients to lenalidomide maintenance therapy or no maintenance therapy. The primary end point was progression-free survival. RESULTS: The median follow-up period was 51.2 months. Both progression-free and overall survival were significantly longer with high-dose melphalan plus stem-cell transplantation than with MPR (median progression-free survival, 43.0 months vs. 22.4 months; hazard ratio for progression or death, 0.44; 95% confidence interval [CI], 0.32 to 0.61; P

Published
2014

10. A 41-gene signature predicts complete response (CR) to Bortezomib-Thalidomide-Dexamethasone (VTD) as induction therapy prior to autologous stem-cell transplantation (ASCT) in multiple myeloma (MM)

Author

Carolina Terragna, Lucia Pantani, Massimo Offidani, Franco Narni, Sara Bringhen, Michele Baccarani, Sergio Cortelazzo, Daniela Donnarumma, Francesca Patriarca, Michele Cavo, Tommaso Caravita, Alfonso Zaccaria, Giuseppe Fioritoni, Giovanni Martinelli, Alessandro Rambaldi, Giorgio La Nasa, Anna Levi, Sandra Durante, Marina Martello, Luca Baldini, Daniel Remondini, Claudia Crippa, Paolo Corradini, Terragna, Carolina, Remondini, Daniel, Martello, Marina, Pezzi, Annalisa, Patriarca, Francesca, Levi, Anna, Pantani, Lucia, Donnarumma, Daniela, Montanaro, Lorenzo, Crippa, Claudia, Bringhen, Sarah, Rambaldi, Alessandro, Offidani, Massimo, Corradini, Paolo, Narni, Franco, Fioritoni, Giuseppe, Zaccaria, Alfonso, Baldini, Luca, Caravita, Tommaso, La Nasa, Giorgio, Cortellazzo, Sergio, Martinelli, Giovanni, Cavo, Michele, Terragna, C, Remondini, D, Durante, S, Martello, M, Patriarca, F, Levi, A, Pantani, L, Donnarumma, D, Crippa, C, Bringhen, S, Rambaldi, A, Offidani, M, Corradini, P, Narni, F, Fioritoni, G, Zaccaria, A, Baldini, L, Caravita, T, La Nasa, G, Cortelazzo, S, Martinelli, G, Baccarani, M, and Cavo, M

Subjects
Oncology, medicine.medical_specialty, education.field_of_study, medicine.medical_treatment, Immunology, Population, Phases of clinical research, Cell Biology, Hematology, Gene signature, Biology, medicine.disease, Bioinformatics, Biochemistry, Isotype, Regimen, Autologous stem-cell transplantation, Internal medicine, medicine, education, Multiple myeloma, Neoadjuvant therapy
Abstract

Abstract 805FN2 Background. Achievement of CR is generally associated with improved clinical outcomes for patients (pts) with MM and represents a primary endpoint of current clinical trials. The GIMEMA Italian Myeloma Network designed a phase 3 study to demonstrate that the triplet VTD regimen was superior over a doublet such as thalidomide-dexamethasone (TD) as induction therapy prior to double ASCT for newly diagnosed MM. On an intention-to-treat basis, the rate of complete or near complete response (CR/nCR) was 31% for the 236 pts on VTD induction therapy, while it was 11% (p Methods. For this purpose, in a molecular substudy to the main clinical study we assessed the ability of gene expression profile (GEP) to predict attainment of CR/nCR in 122 pts enrolled in the VTD arm of the study. Their characteristics at baseline, including cytogenetic abnormalities, were comparable with those of the whole population of 236 pts. Highly purified CD138+ plasma cells were obtained at diagnosis from each of these pts and were profiled for gene expression using the Affymetrix U133 Plus2.0 platform. In order to build a low-dimensional signature with optimal performance, genomic data were analyzed with an original algorithm that exploits quadratic discriminant analysis with a bottom-up approach that builds N-gene signatures starting from two-dimensional signatures. Gene models were applied to test datasets to predict achievement of either CR/nCR or less than nCR, and classification performances were validated by a leave-one-out crossvalidation procedure. Results. Thirty four pts out of the 122 (28%) who were included in the present analysis achieved a CR/nCR, while the remaining 88 patients failed this objective. The molecular approach described above allowed to identify several gene signatures among which we choose a 163-gene signature that provided a predictive capability of 79% sensitivity, 87% specificity, 71% positive predictive value (PPV) and 92% negative predictive value (NPV). These expression values were used in an unsupervised hierarchical clustering to stratify the population of 122 profilated pts into 3 well defined subgroups. Seventy nine pts were included in subgroup A, while the remaining 43 pts were included in either subgroup B (n=22) or subgroup C (n=21). Notably, 19 out the 34 CR/nCR pts (56%) clustered in subgroup B, whereas the remaining 15 pts were randomly distributed within subgroup A. Analysis of demographic and disease characteristics of the pts belonging to the 3 major subgroups, revealed that in subgroup B the frequencies of pts carrying del(13q) (78%) or del(17p) (22%) or with an IgA isotype (54%) were significantly higher in comparison with the corresponding values found in subgroup A (47%, 4%, and 10%, respectively) and subgroup C (38%, 10%, and 5%, respectively). In order to obtain a more feasible set of genes predictive of CR/nCR, several smaller signatures originating from the 163-gene signature were further analyzed by means of the same algorithm described above. The best predictive capability was obtained with a 41-gene signature that provided 88% sensitivity, 97% specificity, 91% PPV and 95% NPV. A GeneGo ® network analysis of genes included in the signatures showed that the most relevant network nodes included tumour suppressor genes (FBXW7 and MAD), genes involved in inflammatory response (TREM1 and TLR4) and genes involved in B cell development (IKZF1, IL10 and NFAM1). Genes included in the signatures do not gather in specific chromosomes, thus confirming the absence of bias on selection of signatures genes, potentially due to prevalence of MM typical chromosomal aberrations. Conclusions. GEP analysis of a subgroup of pts who received VTD induction therapy allowed to provide a 41-gene signature that was able to predict attainment of CR/nCR and, conversely, failure to achieve at least nCR in 91% and 95% of cases, respectively. These favorable results might represent a first step towards the possible application of a tailored therapy based on the single patient's genetic background. Supported by: Fondazione Del Monte di Bologna e Ravenna, Ateneo RFO grants (M.C.) BolognAIL. Disclosures: Bringhen: Celgene: Honoraria; Janssen-Cilag: Honoraria; Novartis: Honoraria; Merck Sharp & Dhome: Membership on an entity's Board of Directors or advisory committees. Offidani:Janssen: Honoraria; Celgene: Honoraria.

Published
2013

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