This phase II study explored the effects of bortezomib consolidation versus observation on myeloma-related bone disease in patients who had a partial response or better after frontline high-dose therapy and autologous stem cell transplantation. Patients were randomized to receive four 35-day cycles of bortezomib 1·6 mg/m(2) intravenously on days 1, 8, 15 and 22, or an equivalent observation period, and followed up for disease status/survival. The modified intent-to-treat population included 104 patients (51 bortezomib, 53 observation). There were no meaningful differences in the primary endpoint of change from baseline to end of treatment in bone mineral density (BMD). End-of-treatment rates (bortezomib versus observation) of complete response/stringent complete response were 22% vs. 11% (P = 0·19), very good partial response or better of 80% vs. 68% (P = 0·17), and progressive disease of 8% vs. 23% (P = 0·06); median progression-free survival was 44·9 months vs. 21·8 months (P = 0·22). Adverse events observed ≥15% more frequently with bortezomib versus observation were diarrhoea (37% vs. 0), peripheral sensory neuropathy (20% vs. 4%), nausea (18% vs. 0) and vomiting (16% vs. 0). Compared with observation, bortezomib appeared to have little impact on bone metabolism/health, but was associated with trends for improved myeloma response and survival.

3 Medical Dept Klinikum Rechts der Isar Technical University Munich Munich Germany

Department of Clinical Therapeutics National and Kapodistrian University of Athens School of Medicine Alexandra General Hospital Athens Greece

Department of Haemato oncology University Hospital Ostrava Ostrava Czech Republic Faculty of Medicine University Ostrava Ostrava Czech Republic

Department of Haematology Akdeniz University Antalya Turkey

Department of Haematology and Oncology LandesKrankenhaus Feldkirch Austria

Department of Haematology Eskisehir Osmangazi University Eskisehir Turkey

Department of Haematology Eskisehir Osmangazi University Eskisehir Turkey Oncologic Sciences Anadolu Health Centre Kocaeli Turkey

Department of Haematology Faculty of Medicine Gazi University Ankara Turkey

Department of Haematology Izmir Medical Park Private Hospital Izmir Turkey

Department of Haematology Karolinska University Hospital Stockholm Sweden

Department of Haematology Medical University Clinic Medical University of Graz Graz Austria

Department of Haematology Oncology and Bone Marrow Transplantation Universitaetsklinikum Eppendorf Hamburg Germany

Department of Haematology Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK Department of Oncology and Metabolism University of Sheffield Sheffield UK

Department of Haematology Vejle Hospital Vejle Denmark IRS University of Southern Denmark Vejle Denmark

Department of Internal Medicine 1 Division of Oncology Medical University of Vienna Vienna General Hospital Vienna Austria

Department of Internal Medicine Marmara University Istanbul Turkey

Department of Medicine Ankara University Ankara Turkey

Department of Radiology Centre for Muscle and Bone Research Charité Campus Benjamin Franklin Berlin Germany

Janssen Cilag AG Zug Switzerland

Janssen Cilag Issy les Moulineaux France

Janssen Cilag Pharmaceutical SACI Athens Greece

Janssen Research and Development Division of Janssen Pharmaceutica NV Beerse Belgium

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$a Sezer, Orhan $u Department of Haematology, Oncology, and Bone Marrow Transplantation, Universitaetsklinikum Eppendorf, Hamburg, Germany.

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$a Effects of single-agent bortezomib as post-transplant consolidation therapy on multiple myeloma-related bone disease: a randomized phase II study / $c O. Sezer, M. Beksac, R. Hajek, G. Sucak, S. Cagirgan, W. Linkesch, O. Meltem Akay, Z. Gülbas, H. Nahi, T. Plesner, JA. Snowden, A. Timurağaoğlu, T. Dechow, A. Lang, T. Tuğlular, J. Drach, G. Armbrecht, A. Potamianou, C. Couturier, RA. Olie, C. Feys, N. Allietta, E. Terpos,

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$a This phase II study explored the effects of bortezomib consolidation versus observation on myeloma-related bone disease in patients who had a partial response or better after frontline high-dose therapy and autologous stem cell transplantation. Patients were randomized to receive four 35-day cycles of bortezomib 1·6 mg/m(2) intravenously on days 1, 8, 15 and 22, or an equivalent observation period, and followed up for disease status/survival. The modified intent-to-treat population included 104 patients (51 bortezomib, 53 observation). There were no meaningful differences in the primary endpoint of change from baseline to end of treatment in bone mineral density (BMD). End-of-treatment rates (bortezomib versus observation) of complete response/stringent complete response were 22% vs. 11% (P = 0·19), very good partial response or better of 80% vs. 68% (P = 0·17), and progressive disease of 8% vs. 23% (P = 0·06); median progression-free survival was 44·9 months vs. 21·8 months (P = 0·22). Adverse events observed ≥15% more frequently with bortezomib versus observation were diarrhoea (37% vs. 0), peripheral sensory neuropathy (20% vs. 4%), nausea (18% vs. 0) and vomiting (16% vs. 0). Compared with observation, bortezomib appeared to have little impact on bone metabolism/health, but was associated with trends for improved myeloma response and survival.

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$a Beksac, Meral $u Department of Medicine, Ankara University, Ankara, Turkey.

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$a Linkesch, Werner $u Department of Haematology, Medical University Clinic, Medical University of Graz, Graz, Austria.

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$a Nahi, Hareth $u Department of Haematology, Karolinska University Hospital, Stockholm, Sweden.

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$a Timurağaoğlu, Ayşen $u Department of Haematology, Akdeniz University, Antalya, Turkey.

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$a Terpos, Evangelos $u Department of Clinical Therapeutics, National and Kapodistrian University of Athens, School of Medicine, Alexandra General Hospital, Athens, Greece.

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