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Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study
M. Cavo, F. Gay, M. Beksac, L. Pantani, MT. Petrucci, MA. Dimopoulos, L. Dozza, B. van der Holt, S. Zweegman, S. Oliva, VHJ. van der Velden, E. Zamagni, GA. Palumbo, F. Patriarca, V. Montefusco, M. Galli, V. Maisnar, B. Gamberi, M. Hansson, A....
Jazyk angličtina Země Velká Británie
Typ dokumentu klinické zkoušky, fáze III, srovnávací studie, časopisecké články, multicentrická studie, randomizované kontrolované studie
- MeSH
- autologní transplantace metody mortalita MeSH
- bortezomib aplikace a dávkování terapeutické užití MeSH
- dexamethason aplikace a dávkování terapeutické užití MeSH
- gastrointestinální nemoci chemicky indukované epidemiologie MeSH
- infekce chemicky indukované epidemiologie MeSH
- injekce subkutánní MeSH
- intravenózní podání MeSH
- konsolidační chemoterapie metody MeSH
- lenalidomid aplikace a dávkování terapeutické užití MeSH
- lidé středního věku MeSH
- lidé MeSH
- melfalan aplikace a dávkování terapeutické užití MeSH
- mnohočetný myelom diagnóza farmakoterapie MeSH
- myelomové proteiny analýza MeSH
- neutropenie chemicky indukované epidemiologie MeSH
- plazmocytom patologie MeSH
- prednison aplikace a dávkování terapeutické užití MeSH
- přežití bez známek nemoci MeSH
- protokoly protinádorové kombinované chemoterapie terapeutické užití MeSH
- staging nádorů MeSH
- transplantace hematopoetických kmenových buněk škodlivé účinky mortalita MeSH
- trombocytopenie chemicky indukované epidemiologie MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze III MeSH
- multicentrická studie MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
BACKGROUND: The emergence of highly active novel agents has led some to question the role of autologous haematopoietic stem-cell transplantation (HSCT) and subsequent consolidation therapy in newly diagnosed multiple myeloma. We therefore compared autologous HSCT with bortezomib-melphalan-prednisone (VMP) as intensification therapy, and bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy with no consolidation. METHODS: In this randomised, open-label, phase 3 study we recruited previously untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network. Eligible patients were aged 18-65 years, had symptomatic multiple myeloma stage 1-3 according to the International Staging System (ISS), measurable disease (serum M protein >10 g/L or urine M protein >200 mg in 24 h or abnormal free light chain [FLC] ratio with involved FLC >100 mg/L, or proven plasmacytoma by biopsy), and WHO performance status grade 0-2 (grade 3 was allowed if secondary to myeloma). Patients were first randomly assigned (1:1) to receive either four 42-day cycles of bortezomib (1·3 mg/m2 administered intravenously or subcutaneously on days 1, 4, 8, 11, 22, 25, 29, and 32) combined with melphalan (9 mg/m2 administered orally on days 1-4) and prednisone (60 mg/m2 administered orally on days 1-4) or autologous HSCT after high-dose melphalan (200 mg/m2), stratified by site and ISS disease stage. In centres with a double HSCT policy, the first randomisation (1:1:1) was to VMP or single or double HSCT. Afterwards, a second randomisation assigned patients to receive two 28-day cycles of consolidation therapy with bortezomib (1·3 mg/m2 either intravenously or subcutaneously on days 1, 4, 8, and 11), lenalidomide (25 mg orally on days 1-21), and dexamethasone (20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12) or no consolidation; both groups received lenalidomide maintenance therapy (10 mg orally on days 1-21 of a 28-day cycle). The primary outcomes were progression-free survival from the first and second randomisations, analysed in the intention-to-treat population, which included all patients who underwent each randomisation. All patients who received at least one dose of study drugs were included in the safety analyses. This study is registered with the EU Clinical Trials Register (EudraCT 2009-017903-28) and ClinicalTrials.gov (NCT01208766), and has completed recruitment. FINDINGS: Between Feb 25, 2011, and April 3, 2014, 1503 patients were enrolled. 1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428). The data cutoff date for the current analysis was Nov 26, 2018. At a median follow-up of 60·3 months (IQR 52·2-67·6), median progression-free survival was significantly improved with autologous HSCT compared with VMP (56·7 months [95% CI 49·3-64·5] vs 41·9 months [37·5-46·9]; hazard ratio [HR] 0·73, 0·62-0·85; p=0·0001). For the second randomisation, the number of events of progression or death at data cutoff was lower than that preplanned for the final analysis; therefore, the results from the second protocol-specified interim analysis, when 66% of events were reached, are reported (data cutoff Jan 18, 2018). At a median follow-up of 42·1 months (IQR 32·3-49·2), consolidation therapy with VRD significantly improved median progression-free survival compared with no consolidation (58·9 months [54·0-not estimable] vs 45·5 months [39·5-58·4]; HR 0·77, 0·63-0·95; p=0·014). The most common grade ≥3 adverse events in the autologous HSCT group compared to the VMP group included neutropenia (513 [79%] of 652 patients vs 137 [29%] of 472 patients), thrombocytopenia (541 [83%] vs 74 [16%]), gastrointestinal disorders (80 [12%] vs 25 [5%]), and infections (192 [30%] vs 18 [4%]). 239 (34%) of 702 patients in the autologous HSCT group and 135 (27%) of 495 in the VMP group had at least one serious adverse event. Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189). 38 (12%) of 311 deaths from first randomisation were likely to be treatment related: 26 (68%) in the autologous HSCT group and 12 (32%) in the VMP group, most frequently due to infections (eight [21%]), cardiac events (six [16%]), and second primary malignancies (20 [53%]). INTERPRETATION: This study supports the use of autologous HSCT as intensification therapy and the use of consolidation therapy in patients with newly diagnosed multiple myeloma, even in the era of novel agents. The role of high-dose chemotherapy needs to be reassessed in future studies, in particular in patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus dexamethasone. FUNDING: Janssen and Celgene.
Azienda USL IRCCS di Reggio Emilia Reggio Emilia Italy
Clinica di Ematologia AOU Ospedali Riuniti di Ancona Ancona Italy
Department of Haematology Aarhus University Hospital Aarhus Denmark
Department of Haematology Alfred Hospital Monash University Melbourne VIC Australia
Department of Haematology Maastricht University Medical Center Maastricht Netherlands
Department of Haematology University of Copenhagen Copenhagen Denmark
Department of Hematology Ankara University School of Medicine Ankara Turkey
Department of Hematology ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Department of Hematology Canisius Wilhelmina Hospital Nijmegen Netherlands
Department of Hematology Erasmus MC Cancer Institute Rotterdam Netherlands
Department of Hematology Haga Hospital The Hague Netherlands
Department of Hematology Leiden University Medical Center Leiden Netherlands
Department of Hematology Radboud University Medical Centre Nijmegen Netherlands
Department of Hematology UMC Utrecht University Utrecht Utrecht Netherlands
Department of Hematology VU University Medical Center Cancer Center Amsterdam Amsterdam Netherlands
Department of Hematology ZNA Stuivenberg Antwerp Belgium
Department of Immunology Erasmus MC Rotterdam Netherlands
Department of Internal Medicine Albert Schweitzer Hospital Dordrecht Netherlands
Department of Internal Medicine Amphia Hospital Breda Breda Netherlands
Department Oncology Hematology Kantonsspital Lucerne Switzerland
Department Oncology Hematology Kantonsspital St Gallen Switzerland
Ematologia e Centro Trapianti IRCCS Ospedale Policlinico San Martino Genoa Italy
Faculty of Medicine Università degli Studi di Perugia Perugia Italy
Haematology Ospedale San Francesco Nuoro Italy
Hematology and Bone Marrow Transplant Unit ASST Papa Giovanni XXIII Bergamo Italy
Hematology Azienda Ospedaliera di Padova Padua Italy
Hematology Department Fondazione IRCCS Istituto Nazionale Tumori Milan Italy
Hematology Unit Ospedale dell'Angelo Mestre Venice Italy
Hematology University Aldo Moro Bari Italy
Instituto Português de Oncologia de Lisboa Francisco Gentil IPOLFG Lisbon Portugal
Isala Kliniek Zwolle Netherlands
Reparto di Ematologia con TMO Ospedale Santa Maria della Misericordia Perugia Italy
SC Ematologia Azienda Ospedaliera S Croce Carle Cuneo Italy
SC Ematologia e Dipartimento di Oncologia Clinica AO Spedali Civili Brescia Italy
Skane University Hospital Lund Sweden
University Hospital and Faculty of Medicine Hradec Kralove Czech Republic
University Hospital Brno Brno Czech Republic
UOSD Ematologia ASL Roma 1 Rome Italy
Wilhelminen Cancer Research Institute Wilhelminenspital Vienna Austria
Citace poskytuje Crossref.org
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- $a Cavo, Michele $u Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy. Electronic address: michele.cavo@unibo.it.
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- $a Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95): a multicentre, randomised, open-label, phase 3 study / $c M. Cavo, F. Gay, M. Beksac, L. Pantani, MT. Petrucci, MA. Dimopoulos, L. Dozza, B. van der Holt, S. Zweegman, S. Oliva, VHJ. van der Velden, E. Zamagni, GA. Palumbo, F. Patriarca, V. Montefusco, M. Galli, V. Maisnar, B. Gamberi, M. Hansson, A. Belotti, L. Pour, P. Ypma, M. Grasso, A. Croockewit, S. Ballanti, M. Offidani, ID. Vincelli, R. Zambello, AM. Liberati, NF. Andersen, A. Broijl, R. Troia, A. Pascarella, G. Benevolo, MD. Levin, G. Bos, H. Ludwig, S. Aquino, AM. Morelli, KL. Wu, R. Boersma, R. Hajek, M. Durian, PA. von dem Borne, T. Caravita di Toritto, T. Zander, C. Driessen, G. Specchia, A. Waage, P. Gimsing, UH. Mellqvist, M. van Marwijk Kooy, M. Minnema, C. Mandigers, AM. Cafro, A. Palmas, S. Carvalho, A. Spencer, M. Boccadoro, P. Sonneveld,
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- $a BACKGROUND: The emergence of highly active novel agents has led some to question the role of autologous haematopoietic stem-cell transplantation (HSCT) and subsequent consolidation therapy in newly diagnosed multiple myeloma. We therefore compared autologous HSCT with bortezomib-melphalan-prednisone (VMP) as intensification therapy, and bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy with no consolidation. METHODS: In this randomised, open-label, phase 3 study we recruited previously untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network. Eligible patients were aged 18-65 years, had symptomatic multiple myeloma stage 1-3 according to the International Staging System (ISS), measurable disease (serum M protein >10 g/L or urine M protein >200 mg in 24 h or abnormal free light chain [FLC] ratio with involved FLC >100 mg/L, or proven plasmacytoma by biopsy), and WHO performance status grade 0-2 (grade 3 was allowed if secondary to myeloma). Patients were first randomly assigned (1:1) to receive either four 42-day cycles of bortezomib (1·3 mg/m2 administered intravenously or subcutaneously on days 1, 4, 8, 11, 22, 25, 29, and 32) combined with melphalan (9 mg/m2 administered orally on days 1-4) and prednisone (60 mg/m2 administered orally on days 1-4) or autologous HSCT after high-dose melphalan (200 mg/m2), stratified by site and ISS disease stage. In centres with a double HSCT policy, the first randomisation (1:1:1) was to VMP or single or double HSCT. Afterwards, a second randomisation assigned patients to receive two 28-day cycles of consolidation therapy with bortezomib (1·3 mg/m2 either intravenously or subcutaneously on days 1, 4, 8, and 11), lenalidomide (25 mg orally on days 1-21), and dexamethasone (20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12) or no consolidation; both groups received lenalidomide maintenance therapy (10 mg orally on days 1-21 of a 28-day cycle). The primary outcomes were progression-free survival from the first and second randomisations, analysed in the intention-to-treat population, which included all patients who underwent each randomisation. All patients who received at least one dose of study drugs were included in the safety analyses. This study is registered with the EU Clinical Trials Register (EudraCT 2009-017903-28) and ClinicalTrials.gov (NCT01208766), and has completed recruitment. FINDINGS: Between Feb 25, 2011, and April 3, 2014, 1503 patients were enrolled. 1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428). The data cutoff date for the current analysis was Nov 26, 2018. At a median follow-up of 60·3 months (IQR 52·2-67·6), median progression-free survival was significantly improved with autologous HSCT compared with VMP (56·7 months [95% CI 49·3-64·5] vs 41·9 months [37·5-46·9]; hazard ratio [HR] 0·73, 0·62-0·85; p=0·0001). For the second randomisation, the number of events of progression or death at data cutoff was lower than that preplanned for the final analysis; therefore, the results from the second protocol-specified interim analysis, when 66% of events were reached, are reported (data cutoff Jan 18, 2018). At a median follow-up of 42·1 months (IQR 32·3-49·2), consolidation therapy with VRD significantly improved median progression-free survival compared with no consolidation (58·9 months [54·0-not estimable] vs 45·5 months [39·5-58·4]; HR 0·77, 0·63-0·95; p=0·014). The most common grade ≥3 adverse events in the autologous HSCT group compared to the VMP group included neutropenia (513 [79%] of 652 patients vs 137 [29%] of 472 patients), thrombocytopenia (541 [83%] vs 74 [16%]), gastrointestinal disorders (80 [12%] vs 25 [5%]), and infections (192 [30%] vs 18 [4%]). 239 (34%) of 702 patients in the autologous HSCT group and 135 (27%) of 495 in the VMP group had at least one serious adverse event. Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189). 38 (12%) of 311 deaths from first randomisation were likely to be treatment related: 26 (68%) in the autologous HSCT group and 12 (32%) in the VMP group, most frequently due to infections (eight [21%]), cardiac events (six [16%]), and second primary malignancies (20 [53%]). INTERPRETATION: This study supports the use of autologous HSCT as intensification therapy and the use of consolidation therapy in patients with newly diagnosed multiple myeloma, even in the era of novel agents. The role of high-dose chemotherapy needs to be reassessed in future studies, in particular in patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus dexamethasone. FUNDING: Janssen and Celgene.
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- 700 1_
- $a Gay, Francesca $u Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.
- 700 1_
- $a Beksac, Meral $u Department of Hematology, Ankara University School of Medicine, Ankara, Turkey.
- 700 1_
- $a Pantani, Lucia $u Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.
- 700 1_
- $a Petrucci, Maria Teresa $u Hematology, Department of Translational and Precision Medicine, Azienda Ospedaliera Policlinico Umberto I, Sapienza University of Rome, Rome, Italy.
- 700 1_
- $a Dimopoulos, Meletios A $u Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
- 700 1_
- $a Dozza, Luca $u Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.
- 700 1_
- $a van der Holt, Bronno $u Department of Trials and Statistics-HOVON Data Centre, Erasmus MC Cancer Institute, Rotterdam, Netherlands.
- 700 1_
- $a Zweegman, Sonja $u Department of Hematology, VU University Medical Center, Cancer Center Amsterdam, Amsterdam, Netherlands.
- 700 1_
- $a Oliva, Stefania $u Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.
- 700 1_
- $a van der Velden, Vincent H J $u Department of Immunology, Erasmus MC, Rotterdam, Netherlands.
- 700 1_
- $a Zamagni, Elena $u Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, S Orsola Malpighi Hospital, Bologna, Italy.
- 700 1_
- $a Palumbo, Giuseppe A $u Dipartimento di Science Mediche Chirurgiche e Tecnologie Avanzate "GF Ingrassia", Università degli Studi di Catania, Catania, Italy.
- 700 1_
- $a Patriarca, Francesca $u Clinical Hematology and Bone Marrow Transplant Centre, S Maria della Misericordia University Hospital, DAME, University of Udine, Udine, Italy.
- 700 1_
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- 700 1_
- $a Galli, Monica $u Hematology and Bone Marrow Transplant Unit, ASST-Papa Giovanni XXIII, Bergamo, Italy.
- 700 1_
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- 700 1_
- $a Gamberi, Barbara $u Azienda USL-IRCCS di Reggio Emilia, Reggio Emilia, Italy.
- 700 1_
- $a Hansson, Markus $u Skane University Hospital, Lund, Sweden.
- 700 1_
- $a Belotti, Angelo $u SC Ematologia e Dipartimento di Oncologia Clinica, AO Spedali Civili, Brescia, Italy.
- 700 1_
- $a Pour, Ludek $u University Hospital Brno, Brno, Czech Republic.
- 700 1_
- $a Ypma, Paula $u Department of Hematology, Haga Hospital, The Hague, Netherlands.
- 700 1_
- $a Grasso, Mariella $u SC Ematologia, Azienda Ospedaliera S Croce-Carle, Cuneo, Italy.
- 700 1_
- $a Croockewit, Alexsandra $u Department of Hematology, Radboud University Medical Centre, Nijmegen, Netherlands.
- 700 1_
- $a Ballanti, Stelvio $u Reparto di Ematologia con TMO, Ospedale Santa Maria della Misericordia, Perugia, Italy.
- 700 1_
- $a Offidani, Massimo $u Clinica di Ematologia, AOU Ospedali Riuniti di Ancona, Ancona, Italy.
- 700 1_
- $a Vincelli, Iolanda D $u Division of Haematology, Grande Ospedale Metropolitano Bianchi-Melacrino-Morelli, Reggio Calabria, Italy.
- 700 1_
- $a Zambello, Renato $u Hematology, Azienda Ospedaliera di Padova, Padua, Italy.
- 700 1_
- $a Liberati, Anna Marina $u Faculty of Medicine, Università degli Studi di Perugia, Perugia, Italy.
- 700 1_
- $a Andersen, Niels Frost $u Department of Haematology, Aarhus University Hospital, Aarhus, Denmark.
- 700 1_
- $a Broijl, Annemiek $u Department of Hematology, Erasmus MC Cancer Institute, Rotterdam, Netherlands.
- 700 1_
- $a Troia, Rossella $u Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.
- 700 1_
- $a Pascarella, Anna $u Hematology Unit, Ospedale dell'Angelo, Mestre, Venice, Italy.
- 700 1_
- $a Benevolo, Giulia $u Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.
- 700 1_
- $a Levin, Mark-David $u Department of Internal Medicine, Albert Schweitzer Hospital, Dordrecht, Netherlands.
- 700 1_
- $a Bos, Gerard $u Department of Haematology, Maastricht University Medical Center, Maastricht, Netherlands.
- 700 1_
- $a Ludwig, Heinz $u Wilhelminen Cancer Research Institute, Wilhelminenspital, Vienna, Austria.
- 700 1_
- $a Aquino, Sara $u Ematologia e Centro Trapianti, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
- 700 1_
- $a Morelli, Anna Maria $u Clinical Hematology, Department of Hematology, Transfusion Medicine and Biotechnology, "Spirito Santo" Civic Hospital, Pescara, Italy.
- 700 1_
- $a Wu, Ka Lung $u Department of Hematology, ZNA Stuivenberg, Antwerp, Belgium.
- 700 1_
- $a Boersma, Rinske $u Department of Internal Medicine, Amphia Hospital Breda, Breda, Netherlands.
- 700 1_
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- 700 1_
- $a Durian, Marc $u University Hospital and Faculty of Medicine, Hradec Kralove, Czech Republic.
- 700 1_
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- 700 1_
- $a Caravita di Toritto, Tommaso $u UOSD Ematologia ASL Roma 1, Rome, Italy.
- 700 1_
- $a Zander, Thilo $u Department Oncology/Hematology, Kantonsspital, Lucerne, Switzerland.
- 700 1_
- $a Driessen, Christoph $u Department Oncology/Hematology, Kantonsspital, St Gallen, Switzerland.
- 700 1_
- $a Specchia, Giorgina $u Hematology, University Aldo Moro, Bari, Italy.
- 700 1_
- $a Waage, Anders $u Department of Hematology, St Olavs Hospital and Norwegian University of Science and Technology, Trondheim, Norway.
- 700 1_
- $a Gimsing, Peter $u Department of Haematology, University of Copenhagen, Copenhagen, Denmark.
- 700 1_
- $a Mellqvist, Ulf-Henrik $u Department of Medicine, Section of Hematology and Coagulation, South Elvsborg Hospital, Gothenburg, Sweden.
- 700 1_
- $a van Marwijk Kooy, Marinus $u Isala Kliniek, Zwolle, Netherlands.
- 700 1_
- $a Minnema, Monique $u Department of Hematology, UMC Utrecht, University Utrecht, Utrecht, Netherlands.
- 700 1_
- $a Mandigers, Caroline $u Department of Hematology, Canisius-Wilhelmina Hospital, Nijmegen, Netherlands.
- 700 1_
- $a Cafro, Anna Maria $u Department of Hematology, ASST Grande Ospedale Metropolitano, Niguarda, Milan, Italy.
- 700 1_
- $a Palmas, Angelo $u Haematology, Ospedale San Francesco, Nuoro, Italy.
- 700 1_
- $a Carvalho, Susanna $u Instituto Português de Oncologia de Lisboa Francisco Gentil, IPOLFG, Lisbon, Portugal.
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