Subcutaneous versus intravenous bortezomib in two different induction therapies for newly diagnosed multiple myeloma: An interim analysis from the prospective GMMG-MM5 trial

Haematologica

Volumn 100, Issue 7, 2015, Pages 964-969

  Merz, Maximilian ^a   Salwender, Hans ^b   Haenel, Mathias ^c   Mai, Elias K ^a   Bertsch, Uta ^a,d   Kunz, Christina ^d   Hielscher, Thomas ^d   Blau, Igor W ^e   Scheid, Christof ^f   Hose, Dirk ^a   Seckinger, Anja ^a   Jauch, Anna ^a   Hillengass, Jens ^a   Raab, Marc S ^a   Schurich, Baerbel ^a   Munder, Markus ^g   Schmidt Wolf, Ingo G H ^h   Gerecke, Christian ⁱ   Lindemann, Hans Walter ^j   Zeis, Matthias ^k   Weisel, Katja ^l   Duerig, Jan ^m   Goldschmidt, Hartmut ^a,d   more..

^a UNIVERSITY HOSPITAL HEIDELBERG   (Germany)

^b Asklepios Hospital Hamburg Altona   (Germany)

^c KLINIKUM CHEMNITZ   (Germany)

^d GERMAN CANCER RESEARCH CENTER DKFZ   (Germany)

^e CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^f UNIVERSITY HOSPITAL OF COLOGNE   (Germany)

^g UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^h UNIVERSITY HOSPITAL BONN   (Germany)

ⁱ Helios Hospital   (Germany)

^j Kath Krankenhaus   (Germany)

^k DEPARTMENT OF CARDIOLOGY   (Germany)

^l UNIVERSITY HOSPITAL TÜBINGEN   (Germany)

^m UNIVERSITY HOSPITAL ESSEN   (Germany)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BORTEZOMIB; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOXORUBICIN; LENALIDOMIDE; MELPHALAN; SYNDECAN 1; ANTINEOPLASTIC AGENT;

AGED; ARTICLE; AUTOLOGOUS STEM CELL TRANSPLANTATION; BLOOD TOXICITY; CONNECTIVE TISSUE DISEASE; CONTROLLED STUDY; DRUG ADMINISTRATION ROUTE; DRUG EFFICACY; DRUG TOLERANCE; FEMALE; FLUORESCENCE IN SITU HYBRIDIZATION; GASTROINTESTINAL DISEASE; HEART DISEASE; HEMATOLOGIC DISEASE; HUMAN; INFECTION; INFESTATION; KIDNEY DISEASE; LYMPHATIC SYSTEM DISEASE; MAJOR CLINICAL STUDY; MALE; METABOLIC DISORDER; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; MUSCULOSKELETAL DISEASE; NUTRITIONAL DISORDER; PERIPHERAL NEUROPATHY; PHASE 3 CLINICAL TRIAL; PROGRESSION FREE SURVIVAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; THROMBOEMBOLISM; TREATMENT RESPONSE; ADULT; CANCER STAGING; CHEMICALLY INDUCED; CLINICAL TRIAL; DRUG ADMINISTRATION; DRUG EFFECTS; INDUCTION CHEMOTHERAPY; INTRAVENOUS DRUG ADMINISTRATION; KIDNEY; MIDDLE AGED; MORTALITY; PATHOLOGY; PROCEDURES; REMISSION; SUBCUTANEOUS DRUG ADMINISTRATION; SURVIVAL ANALYSIS;

ADULT; AGED; ANTINEOPLASTIC AGENTS; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BORTEZOMIB; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOXORUBICIN; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; INDUCTION CHEMOTHERAPY; INJECTIONS, INTRAVENOUS; INJECTIONS, SUBCUTANEOUS; KIDNEY; MALE; MIDDLE AGED; MULTIPLE MYELOMA; NEOPLASM STAGING; PERIPHERAL NERVOUS SYSTEM DISEASES; PROSPECTIVE STUDIES; REMISSION INDUCTION; SURVIVAL ANALYSIS;

EID: 84936095192     PISSN: 03906078     EISSN: 15928721     Source Type: Journal    
DOI: 10.3324/haematol.2015.124347     Document Type: Article

References (24)

1. Moreau P, Richardson PG, Cavo M, et al. Proteasome inhibitors in multiple myeloma: 10 years later. Blood. 2012;120(5):947-959.
2. Sonneveld P, Goldschmidt H, Rosiñol L, et al. Bortezomib-based versus nonbortezomib- based induction treatment before autologous stem-cell transplantation in patients with previously untreated multiple myeloma: a meta-analysis of phase III randomized, controlled trials. J Clin Oncol. 2013;31(26):3279-3287.
3. Moreau P, Pylypenko H, Grosicki S, et al. Subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma: a randomised, phase 3, non-inferiority study. Lancet Oncol. 2011;12(5):431-440.
4. Arnulf B, Pylypenko H, Grosicki S, et al. Updated survival analysis of a randomized phase III study of subcutaneous versus intravenous bortezomib in patients with relapsed multiple myeloma. Haematologica. 2012;97(12):1925-1928.
5. Lok A, Mocquard J, Bourcier J, et al. Subcutaneous bortezomib incorporated into the bortezomib-thalidomide-dexamethasone regimen as part of front-line therapy in the context of autologous stem cell transplantation for multiple myeloma. Haematologica. 2014;99(3):e33-34.
6. Brioli A, Zannetti BA, Zamagni E, et al. Peripheral neuropathy induced by subcutaneous bortezomib-based induction therapy for newly diagnosed multiple myeloma. Haematologica. 2014;99(11):e242-243
7. Goldschmidt H, Duerig J, Bertsch U, et al. GMMG MM5 trial in newly diagnosed multiple myeloma to evaluate PAd vs VCD induction prior to high dose treatment followed by lenalidomide consolidation and maintenance – final analysis on induction therapy. Blood. 2013; 122(21):3369-3369
8. Kyle RA, Rajkumar SV. Criteria for diagnosis, staging, risk stratification and response assessment of multiple myeloma. Leukemia. 2009;23(1):3-9.
9. Greipp PR, San Miguel J, Durie BG, et al. International staging system for multiple myeloma. J Clin Oncol. 2005;23(15):3412-3420.
10. Durie BG, Harousseau JL, Miguel JS, et al. International uniform response criteria for multiple myeloma. Leukemia. 2006;20(9):1467-1473.
11. Neben K, Lokhorst HM, Jauch A, et al. Administration of bortezomib before and after autologous stem cell transplantation improves outcome in multiple myeloma patients with deletion 17p. Blood. 2012;119(4):940-948.
12. Aghajanian C, Soignet S, Dizon DS, et al. A phase I trial of the novel proteasome inhibitor PS341 in advanced solid tumor malignancies. Clin Cancer Res. 2002;8(8): 2505-2511.
13. Orlowski RZ, Stinchcombe TE, Mitchell BS, et al. Phase I trial of the proteasome inhibitor PS-341 in patients with refractory hematologic malignancies. J Clin Oncol. 2002;20(22):4420-4427.
14. Richardson PG, Sonneveld P, Schuster MW, et al. Reversibility of symptomatic peripheral neuropathy with bortezomib in the phase III APEX trial in relapsed multiple myeloma: impact of a dose-modification guideline. Br J Haematol. 2009;144(6):895-903.
15. Moreau P, Coiteux V, Hulin C, et al. Prospective comparison of subcutaneous versus intravenous administration of bortezomib in patients with multiple myeloma. Haematologica. 2008;93(12):1908-1911.
16. Moreau P, Karamanesht II, Domnikova N, et al. Pharmacokinetic, pharmacodynamic and covariate analysis of subcutaneous versus intravenous administration of bortezomib in patients with relapsed multiple myeloma. Clin Pharmacokinet. 2012;51 (12):823-829.
17. Broyl A, Corthals SL, Jongen JL, et al. Mechanisms of peripheral neuropathy associated with bortezomib and vincristine in patients with newly diagnosed multiple myeloma: a prospective analysis of data from the HOVON-65/GMMG-HD4 trial. Lancet Oncol. 2010;11(11):1057-1065.
18. Tacchetti P, Terragna C, Galli M, et al. Bortezomib- and thalidomide-induced peripheral neuropathy in multiple myeloma: clinical and molecular analyses of a phase 3 study. Am J Hematol. 2014;89(12): 1085-1091.
19. Cavo M, Tacchetti P, Patriarca F, et al. 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. Lancet. 2010;376(9758):2075-2085.
20. Rosiñol L, Oriol A, Teruel AI, et al. Superiority of bortezomib, thalidomide, and dexamethasone (VTD) as induction pretransplantation therapy in multiple myeloma: a randomized phase 3 PETHEMA/GEM study. Blood. 2012;120(8):1589-1596.
21. Moreau P, Avet-Loiseau H, Facon T, et al. Bortezomib plus dexamethasone versus reduced-dose bortezomib, thalidomide plus dexamethasone as induction treatment before autologous stem cell transplantation in newly diagnosed multiple myeloma. Blood. 2011;118(22):5752-5758.
22. McCarthy PL, Hahn T. Strategies for induction, autologous hematopoietic stem cell transplantation, consolidation, and maintenance for transplantation-eligible multiple myeloma patients. Hematology Am Soc Hematol Educ Program. 2013;496-503.
23. Moreau P, Attal M, Pégourié B, et al. Achievement of VGPR to induction therapy is an important prognostic factor for longer PFS in the IFM 2005-01 trial. Blood. 2011;117(11):3041-3044.
24. Roussel M, Lauwers-Cances V, Robillard N, et al. Front-line transplantation program with lenalidomide, bortezomib, and dexamethasone combination as induction and consolidation followed by lenalidomide maintenance in patients with multiple myeloma: a phase II study by the Intergroupe Francophone du Myélome. J Clin Oncol. 2014;32(25):2712-2717.