Effects of single-agent bortezomib as post-transplant consolidation therapy on multiple myeloma-related bone disease: a randomized phase II study
Language English Country England, Great Britain Media print-electronic
Document type Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
28382618
DOI
10.1111/bjh.14637
Knihovny.cz E-resources
- Keywords
- bone, bone mineral density, bortezomib, consolidation, multiple myeloma,
- MeSH
- Biomarkers blood MeSH
- Bortezomib administration & dosage adverse effects therapeutic use MeSH
- Adult MeSH
- Kaplan-Meier Estimate MeSH
- Consolidation Chemotherapy methods MeSH
- Middle Aged MeSH
- Humans MeSH
- Multiple Myeloma complications drug therapy physiopathology MeSH
- Follow-Up Studies MeSH
- Osteolysis drug therapy etiology physiopathology MeSH
- Antineoplastic Agents administration & dosage adverse effects therapeutic use MeSH
- Drug Administration Schedule MeSH
- Aged MeSH
- Stem Cell Transplantation MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Biomarkers MeSH
- Bortezomib MeSH
- Antineoplastic Agents MeSH
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/m2 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 Haemato oncology University Hospital 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 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 Sheffield Teaching Hospitals NHS Foundation Trust Sheffield UK
Department of Haematology Vejle Hospital Vejle Denmark
Department of Internal Medicine Marmara University Istanbul Turkey
Department of Medicine Ankara University Ankara Turkey
Department of Oncology and Metabolism University of Sheffield Sheffield UK
Faculty of Medicine University Ostrava Ostrava Czech Republic
IRS University of Southern Denmark Vejle Denmark
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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