Safety and efficacy of bortezomib-melphalan-prednisone-thalidomide followed by bortezomib-thalidomide maintenance (VMPT-VT) versus bortezomib- melphalanprednisone (VMP) in untreated multiple myeloma patients with renal impairment

Blood

Volumn 118, Issue 22, 2011, Pages 5759-5766

  Morabito, Fortunato ^a   Gentile, Massimo ^a   Mazzone, Carla ^a   Rossi, Davide ^b   Di Raimondo, Francesco ^c   Bringhen, Sara ^d   Ria, Roberto ^e   Offidani, Massimo ^f   Patriarca, Francesca ^g   Nozzoli, Chiara ^h   Petrucci, Maria Teresa ⁱ   Benevolo, Giulia ^j   Vincelli, Iolanda ^k   Guglielmelli, Tommasina ^l   Grasso, Mariella ^m   Marasca, Roberto ⁿ   Baldini, Luca ^o   Montefusco, Vittorio ^p   Musto, Pellegrino ^q   Cascavilla, Nicola ^r   Majolino, Ignazio ^s   Musolino, Caterina ^t   Cavo, Michele ^u   Boccadoro, Mario ^d   Palumbo, Antonio ^d   more..

^a Azienda Ospedaliera di Cosenza   (Italy)

^b UNIVERSITY OF EASTERN PIEDMONT   (Italy)

^c UNIVERSITY OF CATANIA   (Italy)

^d UNIVERSITY OF TURIN   (Italy)

^e POLICLINICO   (Italy)

^f OSPEDALI RIUNITI   (Italy)

^g UNIVERSITY OF UDINE   (Italy)

^h CAREGGI UNIVERSITY HOSPITAL   (Italy)

ⁱ SAPIENZA UNIVERSITY OF ROME   (Italy)

^j MAURIZIANO HOSPITAL   (Italy)

^k BIANCHI MELACRINO MORELLI HOSPITAL   (Italy)

^l SAN LUIGI GONZAGA HOSPITAL   (Italy)

^m A O S Croce e Carle   (Italy)

ⁿ UNIVERSITY OF MODENA AND REGGIO EMILIA   (Italy)

^o UNIVERSITY OF MILAN   (Italy)

^p NATIONAL CANCER INSTITUTE   (Italy)

^q REFERRAL CANCER CENTER OF BASILICATA   (Italy)

^r CASA SOLLIEVO DELLA SOFFERENZA HOSPITAL   (Italy)

^s SAN CAMILLO FORLANINI HOSPITAL   (Italy)

^t UNIVERSITY OF MESSINA   (Italy)

^u UNIVERSITY OF BOLOGNA   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

BORTEZOMIB; CREATININE; MELPHALAN; PREDNISONE; THALIDOMIDE;

AGED; ANEMIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER PATIENT; CONTROLLED STUDY; CREATININE BLOOD LEVEL; DRUG EFFICACY; DRUG SAFETY; DRUG WITHDRAWAL; FEMALE; GASTROINTESTINAL SYMPTOM; GLOMERULUS FILTRATION RATE; HEART DISEASE; HUMAN; INFECTION; KIDNEY DYSFUNCTION; KIDNEY FUNCTION; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; NEURALGIA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; SENSORY NEUROPATHY; SKIN DISEASE; SYSTEMIC DISEASE; THROMBOCYTOPENIA; THROMBOEMBOLISM; VASCULAR DISEASE;

EID: 82155201722     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2011-05-353995     Document Type: Article

References (37)

1. Alexanian R, Barlogie B, Dixon D. Renal failure in multiple myeloma: pathogenesis and prognostic implications. Arch Intern Med. 1990;150(8):1693- 1695.
2. Dimopoulos MA, Kastritis E, Rosinol L, et al. Pathogenesis and treatment of renal failure in multiple myeloma. Leukemia. 2008;22(8):1485- 1493.
3. Knudsen LM, Hjorth M, Hippe E. Renal failure in multiple myeloma: reversibility and impact on the prognosis. Nordic Myeloma Study Group. Eur J Haematol. 2000;65(3):175-181.
4. Kyle RA, Gertz MA, Witzig TE, et al. Review of 1027 patients with newly diagnosed multiple myeloma. Mayo Clin Proc. 2003;78(1):21-33. (Pubitemid 36033957)
5. Terpos E, Katodritou E, Tsiftsakis E, et al. Cystatin-C is an independent prognostic factor for survival in multiple myeloma and is reduced by bortezomib administration. Haematologica. 2009; 94(3):372-379.
6. Lin J, Markowitz GS, Valeri AM, et al. Renal monoclonal immunoglobulin deposition disease: the disease spectrum. J Am Soc Nephrol. 2001; 12(7):1482-1492. (Pubitemid 32666331)
7. Sanders PW. Pathogenesis and treatment of myeloma kidney. J Lab Clin Med. 1994;124(4):484- 488.
8. Torra R, Bladé J, Cases A, et al. Patients with multiple myeloma and renal failure requiring long term dialysis: presenting features, response to therapy and outcome in a series of 20 cases. Br J Haematol. 1995;91(4):854-859.
9. Ying WZ, Sanders PW. Mapping the binding domain of immunoglobulin light chains for Tamm- Horsfall protein. Am J Pathol. 2001;158(5):1859- 1866.
10. Herrera GA, Sanders PW. Paraproteinemic renal diseases that involve the tubulo-interstitium. Contrib Nephrol. 2007;153:105-115. (Pubitemid 44836017)
11. Rayner HC, Haynes AP, Thompson JR, et al. Perspectives in multiple myeloma: survival, prognostic factors and disease complications in a single centre between 1975 and 1988. Q J Med. 1991; 79(290):517-525.
12. Augustson BM, Begum G, Dunn JA, et al. Early mortality after diagnosis of multiple myeloma: analysis of patients entered onto the United Kingdom Medical Research Council trials between 1980 and 2002-Medical Research Council Adult Leukaemia Working Party. J Clin Oncol. 2005; 23(36):9219-9226.
13. Eleutherakis-Papaiakovou V, Bamias A, Gika D, et al. Renal failure in multiple myeloma: incidence, correlations, and prognostic significance. Leuk Lymphoma. 2007;48(2):337-341. (Pubitemid 46994883)
14. Bladé J, Fernandez-Llama P, Bosch F, et al. Renal failure in multiple myeloma: presenting features and predictors of outcome in a series of 94 patients. Arch Intern Med. 1998;158(17):1889- 1893.
15. Jagannath S, Barlogie B, Berenson JR, et al. Bortezomib in recurrent and/or refractory multiple myeloma: initial clinical experience in patients with impaired renal function. Cancer. 2005; 103(6):1195-1200. (Pubitemid 40328090)
16. San-Miguel JF, Richardson PG, Sonneveld P, et al. Efficacy and safety of bortezomib in patients with renal impairment: results from the APEX phase 3 study. Leukemia. 2008;22(4):842-849. (Pubitemid 351552634)
17. Bladé J, Sonneveld P, San Miguel JF, et al. Pegylated liposomal doxorubicin plus bortezomib in relapsed or refractory multiple myeloma: efficacy and safety in patients with renal function impairment. Clin Lymphoma Myeloma. 2008;8(6):352- 355.
18. Morabito F, Gentile M, Ciolli S, et al. Safety andefficacy of bortezomib-based regimens for multiple myeloma patients with renal impairment: a retrospective study of Italian Myeloma Network GIMEMA. Eur J Haematol. 2010;84(3):223-228.
19. Dimopoulos MA, Richardson PG, Schlag R, et al. VMP (bortezomib, melphalan, and prednisone) is active and well tolerated in newly diagnosed patients with multiple myeloma with moderately impaired renal function, and results in reversal of renal impairment: cohort analysis of the phase III VISTA study. J Clin Oncol. 2009;27(36):6086- 6093.
20. Chanan-Khan AA, Kaufman JL, Mehta J, et al. Activity and safety of bortezomib in multiple myeloma patients with advanced renal failure: a multicenter retrospective study. Blood. 2007;109(6): 2604-2606. (Pubitemid 46425908)
21. Ludwig H, Drach J, Graf H, et al. Reversal of acute renal failure by bortezomib-based chemotherapy in patients with multiple myeloma. Haematologica. 2007;92(10):1411-1414. (Pubitemid 350144160)
22. Ludwig H, Adam Z, Hajek R, et al. Bortezomib doxorubicin-dexamethasone (BDD) in patients with acute light chain induced renal failure (ARF) in multiple myeloma (MM): final results of a phase II study [abstract]. Blood. 2009;114(22):1486. Abstract 3862.
23. Tosi P, Zamagni E, Cellini C, et al. Thalidomide alone or in combination with dexamethasone in patients with advanced, relapsed or refractory multiple myeloma and renal failure. Eur J Haematol. 2004;73(2):98-103. (Pubitemid 38980109)
24. Kastritis E, Anagnostopoulos A, Roussou M, et al. Reversibility of renal failure in newly diagnosed multiple myeloma patients treated with high dose dexamethasone-containing regimens and the impact of novel agents. Haematologica. 2007; 92(10):546-549. (Pubitemid 350144300)
25. Palumbo A, Bringhen S, Rossi D, et al. Bortezomib-melphalan-prednisone- thalidomide followed by maintenance with bortezomibthalidomide compared with bortezomibmelphalan- prednisone for initial treatment of multiple myeloma: a randomized controlled trial. J Clin Oncol. 2010;28(34):5101-5109.
26. Durie BG, Harousseau JL, Miguel JS, et al. International uniform response criteria for multiple myeloma. Leukemia. 2006;20(9):1467-1473. (Pubitemid 44264086)
27. National Cancer Institute. Cancer Therapy Evaluation Program. Common Terminology Criteria for Adverse Events, v3.0. http:// ctep.cancer.gov/ protocolDevelopment/electronic-applications/ ctc.htm#ctc-v3.0. Accessed October 10, 2011.
28. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron. 1976; 16(1):31-41.
29. Bauer C, Melamed ML, Hostetter TH. Staging of chronic kidney disease: time for a course correction. J Am Soc Nephrol. 2008;19(5):844-846.
30. Levey AS, Coresh J, Balk E, et al. National Kidney Foundation practice guidelines for chronic kidney disease: evaluation, classification, and stratification. Ann Intern Med. 2003;139(2):137- 147.
31. Ludwig H, Adam Z, Hajek R, et al. Bortezomib doxorubicin-dexamethasone (BDD) for reversal of acute light chain induced renal failure (ARF) in multiple myeloma (MM): results from a phase II study [abstract]. Blood. 2008;112(11):1261a. Abstract 3682.
32. Ailawadhi S, Mashtare TL, Coignet MV, et al. Renal dysfunction does not affect clinical response in multiple myeloma (MM) patients treated with bortezomib-based regimens [abstract]. Blood. 2007;110(11):442a. Abstract 1477.
33. Dimopoulos MA, Roussou M, Gavriatopoulou M, et al. Reversibility of renal impairment in patients with multiple myeloma treated with bortezomib based regimens: identification of predictive factors. Clin Lymphoma Myeloma. 2009;9(4):302- 306.
34. Roussou M, Kastritis E, Migkou M, et al. Treatment of patients with multiple myeloma complicated by renal failure with bortezomib-based regimens. Leuk Lymphoma. 2008;49(5):890-895. (Pubitemid 351942741)
35. Gladney SP, Lonial S, Kaufman JL. Multiple myeloma presenting with advanced renal failure: a case report and new treatment options. Clin Lymphoma Myeloma. 2008;8(1):52-54. (Pubitemid 351449719)
36. Malani AK, Gupta V, Rangineni R. Bortezomib and dexamethasone in previously untreated multiple myeloma associated with renal failure and reversal of renal failure. Acta Haematol. 2006; 116(4):255-258. (Pubitemid 44795905)
37. Mohrbacher A, Levine AM. Reversal of advanced renal dysfunction on bortezomib treatment in multiple myeloma patients [abstract]. J Clin Oncol. 2005;23(16S): Abstract 6714.