Lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed or refractory multiple myeloma and renal impairment

International Journal of Hematology

Volumn 101, Issue 6, 2015, Pages 569-577

  Zhou, Dao bin ^a   Yu, Li ^b   Du, Xin ^c   Jin, Jie ^d   Cai, Zhen ^d   Chen, Fangping ^e   Ke, Xiaoyan ^f   Li, Xiao ^g   Wu, Depei ^h   Meng, Fanyi ⁱ   Ai, Huisheng ^j   Zhang, Jingshan ^k   DeMarco, Dena ^k   Chen, Nianhang ^k   Mei, Jay ^k   Wang, Jianmin ^l   Hou, Jian ^m  

^a PEKING UNION MEDICAL COLLEGE HOSPITAL   (China)

^b CHINESE PLA GENERAL HOSPITAL   (China)

^c GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL   (China)

^d ZHEJIANG UNIVERSITY   (China)

^e CENTRAL SOUTH UNIVERSITY   (China)

^f PEKING UNIVERSITY THIRD HOSPITAL   (China)

^g Shanghai 6th Hospital   (China)

^h THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY   (China)

ⁱ SOUTHERN MEDICAL UNIVERSITY   (China)

^j The 307 PLA Hospital   (China)

^k CELGENE CORPORATION   (United States)

^l SECOND MILITARY MEDICAL UNIVERSITY   (China)

^m SECOND MILITARY MEDICAL UNIVERSITY   (China)

more..

Author keywords

Chinese; Lenalidomide; Multiple Myeloma; Relapsed Refractory; Renal Insufficiency

Indexed keywords

DEXAMETHASONE; LENALIDOMIDE; ANTINEOPLASTIC HORMONE AGONISTS AND ANTAGONISTS; IMMUNOLOGIC FACTOR; THALIDOMIDE;

ADULT; ADVANCED CANCER; AGED; ANEMIA; ARTICLE; BACKACHE; BONE PAIN; BRONCHOPNEUMONIA; CANCER SURVIVAL; CHINESE; CREATININE CLEARANCE; DISEASE COURSE; DISEASE SEVERITY; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERCALCEMIA; HYPERGLYCEMIA; HYPERURICEMIA; HYPOALBUMINEMIA; HYPOCALCEMIA; HYPOKALEMIA; KIDNEY FAILURE; KIDNEY FUNCTION; LEUKOPENIA; LOW DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTIPLE MYELOMA; NEUTROPENIA; OVERALL SURVIVAL; PNEUMONIA; PROGRESSION FREE SURVIVAL; REGISTRATION; RELAPSE; RELAPSED OR REFRACTORY MULTIPLE MYELOMA; RENOVASCULAR HYPERTENSION; RETROSPECTIVE STUDY; THROMBOCYTOPENIA; UPPER RESPIRATORY TRACT INFECTION; ANALOGS AND DERIVATIVES; CHINA; CLINICAL TRIAL; COMPLICATION; DISEASE FREE SURVIVAL; MIDDLE AGED; RENAL INSUFFICIENCY; TUMOR RECURRENCE; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, HORMONAL; CHINA; DEXAMETHASONE; DISEASE-FREE SURVIVAL; FEMALE; HUMANS; IMMUNOLOGIC FACTORS; MALE; MIDDLE AGED; MULTIPLE MYELOMA; NEOPLASM RECURRENCE, LOCAL; RENAL INSUFFICIENCY; THALIDOMIDE;

EID: 84930570570     PISSN: 09255710     EISSN: 18653774     Source Type: Journal    
DOI: 10.1007/s12185-015-1771-7     Document Type: Article

References (30)

1. Revlimid. Chinese Product Information. Revlimid package insert, produced by Celgene Corporation. Product approval date January 2013.
2. Hou J, Du X, Jin J, Cai Z, Chen F, Zhou DB, et al. A multicenter, open-label, phase 2 study of lenalidomide plus low-dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma: the MM-021 trial. J Hematol Oncol. 2013;6:41.
3. Weber DM, Chen C, Niesvizky R, Wang M, Belch A, Stadtmauer EA, et al. Multiple Myeloma (009) Study Investigators: Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007;357:2133–42.
4. Dimopoulos M, Spencer A, Attal M, Prince HM, Harousseau JL, Dmoszynska A, et al. Multiple Myeloma (010) Study Investigators: Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007;357:2123–32.
5. Richardson PG, Schlossman RL, Weller E, Hideshima T, Mitsiades C, Davies F, et al. Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma. Blood. 2002;100:3063–7.
6. Iida S, Chou T, Okamoto S, Nagai H, Hatake K, Murakami H, et al. Lenalidomide plus dexamethasone treatment in Japanese patients with relapsed/refractory multiple myeloma. Int J Hematol. 2010;92:118–26.
7. Alexanian R, Barlogie B, Dixon D. Renal failure in multiple myeloma. Pathogenesis and prognostic implications. Arch Intern Med. 1990;150:1693–5.
8. Augustson BM, Begum G, Dunn JA, Barth NJ, Davies F, Morgan G, 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;23:9219–26.
9. Eleutherakis-Papaiakovou V, Bamias A, Gika D, Simeonidis A, Pouli A, Anagnostopoulos A, et al. Renal failure in multiple myeloma: incidence, correlations, and prognostic significance. Leuk Lymphoma. 2007;48:337–41.
10. Kyle RA, Gertz MA, Witzig TE, Lust JA, Lacy MQ, Dispenzieri A, et al. Review of 1027 patients with newly diagnosed multiple myeloma. Mayo Clin Proc. 2003;78:21–33.
11. Goldschmidt H, Lannert H, Bommer J, Ho AD. Renal failure in multiple myeloma “the myeloma kidney”: state of the art. Saudi J Kidney Dis Transpl. 2001;12:145–50.
12. Abbott KC, Agodoa LY. Multiple myeloma and light chain-associated nephropathy at end-stage renal disease in the United States: patient characteristics and survival. Clin Nephrol. 2001;56:207–10.
13. Batuman V. The pathogenesis of acute kidney impairment in patients with multiple myeloma. Adv Chronic Kidney Dis. 2012;19:282–6.
14. Dimopoulos MA, Kastritis E, Rosinol L, Bladé J, Ludwig H. Pathogenesis and treatment of renal failure in multiple myeloma. Leukemia. 2008;22:1485–93.
15. Kastritis E, Anagnostopoulos A, Roussou M, Gika D, Matsouka C, Barmparousi D, 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;92:546–9.
16. Dimopoulos MA, Terpos E, Chanan-Khan A, Leung N, Ludwig H, Jagannath S, et al. Renal impairment in patients with multiple myeloma: a consensus statement on behalf of the International Myeloma Working Group. J Clin Oncol. 2010;28:4976–84.
17. Dimopoulos MA, Roussou M, Gkotzamanidou M, Nikitas N, Psimenou E, Mparmparoussi D, et al. The role of novel agents on the reversibility of renal impairment in newly diagnosed symptomatic patients with multiple myeloma. Leukemia. 2013;27:423–9.
18. Roussou M, Kastritis E, Christoulas D, Migkou M, Gavriatopoulou M, Grapsa I, et al. Reversibility of renal failure in newly diagnosed patients with multiple myeloma and the role of novel agents. Leuk Res. 2010;34:1395–7.
19. 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;65:175–81.
20. Chen N, Lau H, Kong L, Kumar G, Zeldis JB, Knight R, et al. Pharmacokinetics of lenalidomide in subjects with various degrees of renal impairment and in subjects on hemodialysis. J Clin Pharmacol. 2007;47:1466–75.
21. Dimopoulos MA, Palumbo A, Attal M, Beksaç M, Davies FE, Delforge M, et al. European Myeloma Network: Optimizing the use of lenalidomide in relapsed or refractory multiple myeloma: consensus statement. Leukemia. 2011;25:749–60.
22. Dimopoulos M, Alegre A, Stadtmauer EA, Goldschmidt H, Zonder JA, de Castro CM, et al. The efficacy and safety of lenalidomide plus dexamethasone in relapsed and/or refractory multiple myeloma patients with impaired renal function. Cancer. 2010;116:3807–14.
23. Dimopoulos MA, Christoulas D, Roussou M, Kastritis E, Migkou M, Gavriatopoulou M, et al. Lenalidomide and dexamethasone for the treatment of refractory/relapsed multiple myeloma: dosing of lenalidomide according to renal function and effect on renal impairment. Eur J Haematol. 2010;85:1–5.
24. Klein U, Neben K, Hielscher T, Heiss C, Ho AD, Goldschmidt H. Lenalidomide in combination with dexamethasone: effective regimen in patients with relapsed or refractory multiple myeloma complicated by renal impairment. Ann Hematol. 2011;90:429–39.
25. MM-024 Expanded Access Program. Trial registration: China State Food and Drug Administration (SFDA) registration (CTA reference numbers: 209 L10808; 209 L10809; 209 L10810; and 209 L10811).
26. Bladé J, Samson D, Reece D, Apperley J, Björkstrand B, Gahrton G, et al. Criteria for evaluating disease response and progression in patients with multiple myeloma treated by high-dose therapy and haemopoietic stem cell transplantation. Myeloma Subcommittee of the EBMT. European Group for Blood and Marrow Transplant. Br J Haematol. 1998;102:1115–23.
27. Chen N, Kasserra C, Reyes J, Liu L, Lau H. Single-dose pharmacokinetics of lenalidomide in healthy volunteers: dose proportionality, food effect, and racial sensitivity. Cancer Chemother Pharmacol. 2012;70:717–25.
28. Chen N, Wen L, Lau H, Surapaneni S, Kumar G. Pharmacokinetics, metabolism and excretion of [(14)C]-lenalidomide following oral administration in healthy male subjects. Cancer Chemother Pharmacol. 2012;69:789–97.
29. Dimopoulos MA, Terpos E, Goldschmidt H, Alegre A, Mark T, Niesvizky R. Treatment with lenalidomide and dexamethasone in patients with multiple myeloma and renal impairment. Cancer Treat Rev. 2012;38:1012–9.
30. Rajkumar SV, Jacobus S, Callander NS, Fonseca R, Vesole DH, Williams ME, et al. Eastern Cooperative Oncology Group: Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial. Lancet Oncol. 2010;11:29–37.