A multicenter, randomized phase III study of bortezomib and ...

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HOVON 104 AL AMYLOIDOSIS Clinical trial protocol version 7, 27 November 2012 Only if the DSMB recommends that the study should be stopped or modified the results will be made public to the principal investigators for further decisions. The interim analysis is planned as soon as the hematological response data at 6 months post-transplant of the first 50% of the patients (18 in arm A and 36 in arm B) are available, which is the primary endpoint for this analysis. Page 10 of 75 EudraCT-No: 2010-021445-42
HOVON 104 AL AMYLOIDOSIS Clinical trial protocol version 7, 27 November 2012 4 Investigators and study administrative structure Responsibility Name Affiliation/Address Sponsor HOVON VU University Medical Center, P.O.Box 7057 1007 MB Amsterdam tel:+31 20 4443797 Representative of Sponsor (HOVON) P.C. Huijgens, chairman P. Sonneveld, treasurer VU University Medical Center Amsterdam Erasmus MC Rotterdam Principal Investigator M.C. Minnema UMC Utrecht, dept of Hematology PO Box 85500 3508 GA Utrecht tel: +31 88 7557230 m.c.minnema@umcutrecht.nl The Netherlands Co-investigator B. P. Hazenberg University of Groningen, dept Rheumatology PO Box 30.001 9700 RB Groningen tel: +31 50 3613432 b.p.c.hazenberg@int.umcg.nl Germany Coordinating investigator Co-investigator Belgium Coordinating Investigator Co-Investigator S. Schönland U. Hegenbart R. Schots K.L. Wu University Hospital of Heidelberg Im Neuenheimer Feld 410 D-69120 Heidelberg tel: +49-6221-56 8001 Stefan.Schoenland@med.uni-heidelberg.de University Hospital of Heidelberg Im Neuenheimer Feld 410 D-69120 Heidelberg tel: +49-6221-56 8001 Ute.Hegenbart@med.uni-heidelberg.de Academisch Ziekenhuis VUB Afd. Medische Oncologie en Hematologie Laarbeeklaan 101 BE - 1090 Brussel rik.schots@az.vub.ac.be ZNA Stuivenberg Afd. Hematologie Lange Beeldekensstraat 267 B-2060 Antwerpen kalung.wu@zna.be Page 11 of 75 EudraCT-No: 2010-021445-42
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Appendix B HOVON 104 AL AMYLOIDOSIS
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Appendix D HOVON 104 AL AMYLOIDOSIS
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Appendix F HOVON 104 AL AMYLOIDOSIS
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Appendix G HOVON 104 AL AMYLOIDOSIS
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Appendix H HOVON 104 AL AMYLOIDOSIS
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Appendix J HOVON 104 AL AMYLOIDOSIS
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Appendix J HOVON 104 AL AMYLOIDOSIS
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Appendix L HOVON 104 AL AMYLOIDOSIS
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A multicenter, randomized phase III study of bortezomib and ...

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