Lenalidomide in multiple myeloma: An evidence-based review of its role in therapy

Core Evidence

Volumn 4, Issue , 2009, Pages 215-245

  Richardson, Paul ^a   Mitsiades, Constantine ^a   Laubach, Jacob ^a   Schlossman, Robert ^a   Ghobrial, Irene ^a   Hideshima, Teru ^a   Munshi, Nikhil ^a   Anderson, Kenneth ^a  

^a HARVARD MEDICAL SCHOOL   (United States)

Author keywords

Evidence; Lenalidomide; Multiple myeloma; Outcomes; Treatment

Indexed keywords

ACETYLSALICYLIC ACID; ALBUMIN; ANTINEOPLASTIC AGENT; BETA 2 MICROGLOBULIN; BORTEZOMIB; C REACTIVE PROTEIN; CISPLATIN; CLARITHROMYCIN; CORTICOSTEROID; CREATININE; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOXORUBICIN; ETOPOSIDE; GRANULOCYTE COLONY STIMULATING FACTOR; HISTONE DEACETYLASE INHIBITOR; INTERLEUKIN 6; LACTATE DEHYDROGENASE; LENALIDOMIDE; LOW MOLECULAR WEIGHT HEPARIN; MELPHALAN; PERIFOSINE; PLERIXAFOR; PREDNISONE; SERUM ALBUMIN; TANESPIMYCIN; THALIDOMIDE; UNINDEXED DRUG; VINCRISTINE; VORINOSTAT;

ABSCESS; ANEMIA; ANXIETY; ASTHENIA; AUTOLOGOUS STEM CELL TRANSPLANTATION; BONE MARROW SUPPRESSION; BRADYCARDIA; CALCIUM BLOOD LEVEL; CANCER COMBINATION CHEMOTHERAPY; CANCER INCIDENCE; CANCER RADIOTHERAPY; CANCER RELAPSE; CANCER SURVIVAL; CONSTIPATION; CREATININE BLOOD LEVEL; DEEP VEIN THROMBOSIS; DRUG COST; DRUG DOSE REDUCTION; DRUG ERUPTION; DRUG FATALITY; DRUG INDICATION; DRUG MEGADOSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSMENORRHEA; EDEMA; EVENT FREE SURVIVAL; EVIDENCE BASED PRACTICE; FATIGUE; FEBRILE NEUTROPENIA; HEART ARREST; HEART MUSCLE ISCHEMIA; HUMAN; HYPERGLYCEMIA; HYPOKALEMIA; IMPOTENCE; INFECTION; KIDNEY FAILURE; LEUKOPENIA; LOW DRUG DOSE; LYMPHOCYTOPENIA; MONOTHERAPY; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; MUSCLE WEAKNESS; MYOPATHY; NEUTROPENIA; OVERALL SURVIVAL; PATIENT COMPLIANCE; PERIPHERAL NEUROPATHY; PNEUMONIA; PROGNOSIS; QUALITY OF LIFE; RESPIRATORY FAILURE; REVIEW; SEDATION; SIDE EFFECT; STROKE; THROMBOCYTOPENIA; THROMBOEMBOLISM; THROMBOSIS; TREATMENT OUTCOME; UNSPECIFIED SIDE EFFECT; VASCULITIS; VENOUS THROMBOEMBOLISM;

EID: 79952692583     PISSN: 15551741     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (140)

1. Celgene Corporation. Revlimid® Prescribing Information. 2009. Accessed April 2009. Available from: http://www.revlimid.com/pdf/REVLIMID-PI. pdf.
2. Dimopoulos M, Spencer A, Attal M, et al; Multiple Myeloma (010) Study Investigators. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007;357:2123-2132.
3. Weber DM, Chen C, Niesvizky R, et al; Multiple Myeloma (009) Study Investigators. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007a;357:2133-2142.
4. Bladé J, Samson D, Reece D, 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;102:1115-1123. (Pubitemid 28435189)
5. Kuehl WM, Bergsagel PL. Multiple myeloma: evolving genetic events and host interactions. Nat Rev Cancer. 2002;2:175-187. (Pubitemid 37328787)
6. Greipp PR, San Miguel J, Durie BG, et al. International staging system for multiple myeloma. J Clin Oncol. 2005;23:3412-3420.
7. [ACS] American Cancer Society). Detailed Guide: Multiple Myeloma. 2008. Accessed April 2008. Available from: http://www.cancer.org/doc-root/CRI/CRI-2- 3x.asp?dt=30.
8. Piazza FA, Gurrieri C, Trentin L, Semenzato G. Towards a new age in the treatment of multiple myeloma. Ann Hematol. 2007;86:159-172. (Pubitemid 46195988)
9. Kumar S, Rajkumar SV. Thalidomide and lenalidomide in the treatment of multiple myeloma. Eur J Cancer. 2006;42:1612-1622. (Pubitemid 44118763)
10. Jemal A, Siegel R, Ward E, et al. Cancer statistics, 2008. CA Cancer J Clin. 2008;58:71-96.
11. [NCI] National Cancer Institute. Surveillance Epidemiology and End Results (SEER). 2008. Accessed April 2008. Available from: http://seer.cancer. gov/.at: http://seer.cancer.gov/statfacts/html/mulmy.html.
12. [IMWG] International Myeloma Working Group. Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group. Br J Haematol. 2003;121:749-757.
13. Durie BG. New approaches to treatment for multiple myeloma: durable remission and quality of life as primary goals. Clin Lymphoma Myeloma. 2005;6:181-190.
14. Durie BG, Salmon SE. A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival. Cancer. 1975;36:842-854.
15. [MMRF] Multiple Myeloma Research Foundation. Multiple myeloma: disease overview. 2008. Accessed April 2008. Available from: http://www.multiplemyeloma. org/downloads/about-myeloma/Disease-Overview.pdf.
16. Mihou D, Katodritou I, Zervas K. Evaluation of five staging systems in 470 patients with multiple myeloma. Haematologica. 2006;91:1149-1150. (Pubitemid 44204791)
17. Gertz MA. Relevant prognostic features of multiple myeloma and the new International Staging System. Leuk Lymphoma. 2007;48:458-468. (Pubitemid 46487752)
18. Rajkumar SV, Greipp PR. Prognostic factors in multiple myeloma. Hematol Oncol Clin North Am. 1999;13:1295-1314. (Pubitemid 30017402)
19. Turesson I, Abildgaard N, Ahlgren T, et al. Prognostic evaluation in multiple myeloma: an analysis of the impact of new prognostic factors. Br J Haematol. 1999;106:1005-1012. (Pubitemid 29463015)
20. Tricot G, Barlogie B, Jagannath S, et al. Poor prognosis in multiple myeloma is associated only with partial or complete deletions of chromosome 13 or abnormalities involving 11q and not with other karyotype abnormalities. Blood. 1995;86:4250-4256.
21. Tricot G, Sawyer JR, Jagannath S, et al. Unique role of cytogenetics in the prognosis of patients with myeloma receiving high-dose therapy and autotransplants. J Clin Oncol. 1997;15:2659-2666. (Pubitemid 27289898)
22. Facon T, Avet-Loiseau H, Guillerm G, et al; Intergroupe Francophone du Myélome. Chromosome 13 abnormalities identified by FISH analysis and serum beta2-microglobulin produce a powerful myeloma staging system for patients receiving high-dose therapy. Blood. 2001;97:1566-1571.
23. Fonseca R, Blood E, Rue M, et al. Clinical and biologic implications of recurrent genomic aberrations in myeloma. Blood. 2003;101: 4569-4575. (Pubitemid 36857829)
24. Fonseca R, Barlogie B, Bataille R, et al. Genetics and cytogenetics of multiple myeloma: a workshop report. Cancer Res. 2004;64:1546-1558. (Pubitemid 38235629)
25. Richardson PG, Barlogie B, Berenson J, et al. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med. 2003;348:2609-2617. (Pubitemid 36741588)
26. Durie BG, Harousseau JL, Miguel JS, et al. International Myeloma Working Group International uniform response criteria for multiple myeloma. Leukemia. 2006;20:1467-1473. (Pubitemid 44264086)
27. [NCCN] National Comprehensive Cancer Network®). NCCN Clinical Practice Guidelines in Oncology™. Multiple myeloma. V.2. Accessed August 2009. Available from: http://www.nccn.org/professionals/physician-gls/PDF/ myeloma.pdf.
28. Anderson KC, Kyle RA, Rajkumar SV, et al; ASH/FDA Panel on Clinical Endpoints in Multiple Myeloma. Clinically relevant end points and new drug approvals for myeloma. Leukemia. 2007;22:231-239.
29. Smith A, Wisloff F, Samson D; UK Myeloma Forum; Nordic Myeloma Study Group; British Committee for Standards in Haematology. Guidelines on the diagnosis and management of multiple myeloma 2005. Br J Haematol. 2006;132:410-451.
30. Bergsagel PL. A kinder, gentler way: control of the proliferative tumor compartment, not cosmetic complete response, should be the goal of myeloma therapy. Leukemia. 2008;22:673-675. (Pubitemid 351552618)
31. Hjorth M, Hellquist L, Holmberg E, Magnusson B, Rödjer S, Westin J. Initial versus deferred melphalan-prednisone therapy for asymptomatic multiple myeloma stage I - a randomized study. Myeloma Group of Western Sweden. Eur J Haematol. 1993;50:95-102. (Pubitemid 23061274)
32. Grignani G, Gobbi PG, Formisano R, et al. A prognostic index for multiple myeloma. Br J Cancer. 1996;73:1101-1107. (Pubitemid 26131232)
33. Kumar S, Lacy MQ, Dispenzieri A, et al. Single agent dexamethasone for pre-stem cell transplant induction therapy for multiple myeloma. Bone Marrow Transplant. 2004;34:485-490. (Pubitemid 39264037)
34. Kumar A, Loughran T, Alsina M, Durie BG, Djulbegovic B. Management of multiple myeloma: a systematic review and critical appraisal of published studies. Lancet Oncol. 2003;4:293-304. (Pubitemid 36592497)
35. Kyle RA, Rajkumar SV. Multiple myeloma. N Engl J Med. 2004;351:1860-1873.
36. Attal M, Harousseau JL, Leyvraz S, et al; Inter-Groupe Francophone du Myélome (IFM). Maintenance therapy with thalidomide improves survival in patients with multiple myeloma. Blood. 2006;108:3289-3294.
37. Mihelic R, Kaufman JL, Lonial S. Maintenance therapy in multiple myeloma. Leukemia. 2007;21:1150-1157. (Pubitemid 46831803)
38. Orlowski RZ. Initial therapy of multiple myeloma patients who are not candidates for stem cell transplantation. Hematology Am Soc Hematol Educ Program. 2006;338-347.
39. Jagannath S. Treatment of myeloma in patients not eligible for transplantation. Curr Treat Options Oncol. 2005;6:241-253. (Pubitemid 40949957)
40. San Miguel JF, Schlag R, Khuageva NK, et al; VISTA Trial Investigators. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med. 2008;359:906-917.
41. Palumbo A, Falco P, Corradini P, et al; GIMEMA - Italian Multiple Myeloma Network. Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma: a report from the GIMEMA - Italian Multiple Myeloma Network. J Clin Oncol. 2007;25:4459-4465. (Pubitemid 350063804)
42. Rajkumar SV, Hayman SR, Lacy MQ, et al. Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma. Blood. 2005;106:4050-4053. (Pubitemid 41775908)
43. Lacy MQ, Gertz MA, Dispenzieri A, et al. Long-term results of response to therapy, time to progression, and survival with lenalidomide plus dexamethasone in newly diagnosed myeloma. Mayo Clin Proc. 2007;82:1179-1184.
44. Thomas S, Alexanian R. Current treatment strategies for multiple myeloma. Clin Lymphoma Myeloma. 2007;7(Suppl 4):S139-S144. (Pubitemid 46848456)
45. Voorhees PM, Orlowski RZ. Emerging role of novel combinations for induction therapy in multiple myeloma. Clin Lymphoma Myeloma. 2006;7:33-41. (Pubitemid 44322768)
46. [FDA] US Food and Drug Administration. Accessed October 2008. FDA approves lenalidomide oral capsules (Revlimid) for use in combination with dexamethasone in patients with multiple myeloma. 2006. Available from: http://www.fda.gov/cder/Offices/OODP/whatsnew/lenalidomide.htm.
47. Rajkumar SV, Fonseca R, Dispenzieri A, et al. Thalidomide in the treatment of relapsed multiple myeloma. Mayo Clin Proc. 2000;75:897-901.
48. Lee CK, Barlogie B, Munshi N, et al. DTPACE: an effective, novel combination chemotherapy with thalidomide for previously treated patients with myeloma. J Clin Oncol. 2003;21:2732-2739. (Pubitemid 46606319)
49. Kumar S, Rajkumar SV. Thalidomide and dexamethasone: therapy for multiple myeloma. Expert Rev Anticancer Ther. 2005;5:759-766. (Pubitemid 41599952)
50. Prince HM, Schenkel B, Mileshkin L. An analysis of clinical trials assessing the efficacy and safety of single-agent thalidomide in patients with relapsed or refractory multiple myeloma. Leuk Lymphoma. 2007b;48:46-55. (Pubitemid 46978623)
51. Dimopoulos MA, Zervas K, Kouvatseas G, et al. Thalidomide and dexamethasone combination for refractory multiple myeloma. Ann Oncol. 2001;12:991-995. (Pubitemid 32725775)
52. Schütt P, Ebeling P, Buttkereit U, et al. Thalidomide in combination with dexamethasone for pretreated patients with multiple myeloma: serum level of soluble interleukin-2 receptor as a predictive factor for response rate and for survival. Ann Hematol. 2005;84:594-600. (Pubitemid 41194547)
53. Terpos E, Mihou D, Szydlo R, et al. The combination of intermediate doses of thalidomide with dexamethasone is an effective treatment for patients with refractory/relapsed multiple myeloma and normalizes abnormal bone remodeling, through the reduction of sRANKL/ osteoprotegerin ratio. Leukemia. 2005;19:1969-1976. (Pubitemid 41554006)
54. Kyriakou C, Thomson K, D'Sa S, et al. Low-dose thalidomide in combination with oral weekly cyclophosphamide and pulsed dexamethasone is a well tolerated and effective regimen in patients with relapsed and refractory multiple myeloma. Br J Haematol. 2005;129:763-770. (Pubitemid 40904526)
55. Prince HM, Adena M, Smith DK, Hertel J. Efficacy of single-agent bortezomib vs single-agent thalidomide in patients with relapsed or refractory multiple myeloma: a systematic comparison. Eur J Haematol. 2007;79:93-99. (Pubitemid 47063262)
56. Richardson PG, Sonneveld P, Schuster MW, et al; Assessment of Proteasome Inhibition for Extending Remissions (APEX) Investigators. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med. 2005;106:2547352:2487-2498.
57. Richardson PG, Sonneveld P, Schuster M, et al. Extended follow-up of a phase 3 trial in relapsed multiple myeloma: final time-to-event results of the APEX trial. Blood. 2007;110:3557-3560. (Pubitemid 350159621)
58. Jagannath S, Barlogie B, Berenson J, et al. A phase 2 study of two doses of bortezomib in relapsed or refractory myeloma. Br J Haematol. 2004;127:165-172. (Pubitemid 39371809)
59. Kropff MH, Bisping G, Wenning D, et al. Bortezomib in combination with dexamethasone for relapsed multiple myeloma. Leuk Res. 2005;29:587-590. (Pubitemid 40327248)
60. Popat R, Oakervee H, Williams C, et al. Bortezomib, low dose intravenous melphalan and dexamethasone for patients with relapsed multiple myeloma [abstract]. Haematologica. 2008;93(Suppl 1):0918.
61. Orlowski RZ, Nagler A, Sonneveld P, et al. Randomized phase III study of pegylated liposomal doxorubicin plus bortezomib compared with bortezomib alone in relapsed or refractory multiple myeloma: combination therapy improves time to progression. J Clin Oncol. 2007;25:3892-3901. (Pubitemid 47477266)
62. Richardson P, Jagannath S, Raje N, et al. Lenalidomide, bortezomib, and dexamethasone (Rev/Vel/Dex) in patients with relapsed or relapsed/refractory multiple myeloma (MM): preliminary results of a phase II study [abstract]. Blood. 2007;110. Abstract 2714.
63. Richardson P, Mitsiades C, Schlossman R, et al. The treatment of relapsed and refractory multiple myeloma. Hematology Am Soc Hematol Educ Program. 2007;317-323.
64. Badros Z, Philip S, Niesvizky R, et al. Phase I trial of vorinostat plus bortezomib (Bort) in relapsed and refractory multiple myeloma (MM) patients (pts) [abstract]. Haematologica. 2008;93(Suppl 1):0642.
65. Weber DM, Jagannath S, Mazumder A, et al. Phase I trial of oral vorinostat in combination with bortezomib in advanced multiple myeloma [abstract]. Haematologica. 2008;93(Suppl 1). Abstract 0640.
66. Palumbo A, Ambrosini MT, Benevolo G, et al; Italian Multiple Myeloma Network; Gruppo Italiano Malattie Ematologicche dell'Adulto. Bortezomib, melphalan, prednisone, and thalidomide for relapsed multiple myeloma. Blood. 2007;109:2767-2772.
67. Zangari M, Anaissie E, Barlogie B, et al. Increased risk of deep-vein thrombosis in patients with multiple myeloma receiving thalidomide and chemotherapy. Blood. 2001;98:1614-1615.
68. Zangari M, Barlogie B, Thertulien R, et al. Thalidomide and deep vein thrombosis in multiple myeloma: risk factors and effect on survival. Clin Lymphoma. 2003;4:32-35. (Pubitemid 36826874)
69. Kastritis E, Dimopoulos MA. The evolving role of lenalidomide in the treatment of hematologic malignancies. Expert Opin Pharmacother. 2007;8:497-509. (Pubitemid 46416418)
70. [EMEA] European Medicines Agency. Scientific Discussion, 2007. Available from: http://www.emea.europa.eu/humandocs/PDFs/EPAR/revlimid/H-717-en6.pdf. Accessed October 2008.
71. Anderson KC. Lenalidomide and thalidomide: mechanisms of action - similarities and differences. Semin Hematol. 2005;42(4 Suppl 4):S3-S8. (Pubitemid 41774591)
72. Hideshima T, Mitsiades C, Tonon G, et al. Understanding multiple myeloma pathogenesis in the bone marrow to identify new therapeutic targets. Nat Rev Cancer. 2007;7:585-598. (Pubitemid 47106630)
73. Bartlett JB, Dredge K, Dalgleish AG. The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer. 2004;4:314-322. (Pubitemid 38525287)
74. Hideshima T, Chauhan D, Shima Y, Richardson PG, Anderson KC. Thalidomide and its analogs overcome drug resistance of human multiple myeloma cells to conventional therapy. Blood. 2000;96:2943-2950.
75. Verhelle D, Corral LG, Wong K, et al. Lenalidomide and CC-4047 inhibit the proliferation of malignant B cells while expanding normal CD34+ progenitor cells. Cancer Res. 2007;67:746-755. (Pubitemid 46192215)
76. List AF. Lenalidomide - the phoenix rises. N Engl J Med. 2007;357:2183-2186. (Pubitemid 350146115)
77. Bruno B, Rotta M, Giaccone L, et al. New drugs for treatment of multiple myeloma. Lancet Oncol. 2004;5:430-442. (Pubitemid 38878047)
78. Knight R. IMiDs: a novel class of immunomodulators. Semin Oncol. 2005;32(4 Suppl 5):S24-S30. (Pubitemid 41111987)
79. Corral LG, Haslett PA, Muller GW, et al. Differential cytokine modulation and T cell activation by two distinct classes of thalidomide analogues that are potent inhibitors of TNF-alpha. J Immunol. 1999;163:380-386. (Pubitemid 29295864)
80. Mitsiades CS, Mitsiades N, Koutsilieris M. The Akt pathway: molecular targets for anti-cancer drug development. Curr Cancer Drug Targets. 2004;4:235-256. (Pubitemid 38560073)
81. Dredge K, Horsfall R, Robinson SP, et al. Orally administered lenalidomide (CC-5013) is anti-angiogenic in vivo and inhibits endothelial cell migration and Akt phosphorylation in vitro. Microvasc Res. 2005;69:56-63. (Pubitemid 40410468)
82. Davies FE, Raje N, Hideshima T, et al. Thalidomide and immunomodulatory derivatives augment natural killer cell cytotoxicity in multiple myeloma. Blood. 2001;98:210-216.
83. Zonder JA, Crowley J, Hussein MA, et al. Superiority of lenalidomide (Len) plus high-dose dexamethasone (HD) compared to HD alone as treatment of newly-diagnosed multiple myeloma (NDMM): results of the randomized, double-blinded, placebo-controlled SWOG trial S0232 [abstract]. Blood. 2007;110:77.
84. Rajkumar SV, Jacobus S, Callander N, et al. Randomized trial of lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone in newly diagnosed myeloma (E4A03), a trial coordinated by the Eastern Cooperative Oncology Group: Analysis of response, survival, and outcome [abstract]. J Clin Oncol. 2008;26:(Suppl):8504.
85. Kumar S, Hayman SR, Buadi FK, et al. Phase II trial of lenalidomide, cyclophosphamide, and dexamethasone (CRd) for newly diagnosed myeloma [abstract]. Blood. 2007;110:190.
86. Richardson PG, Lonial S, Jakubowiak A, et al. Safety and efficacy of lenalidomide (Len), bortezomib (Bz), and dexamethasone (Dex) in patients (pts) with newly diagnosed multiple myeloma (MM): A phase I/II study [abstract]. J Clin Oncol. 2008;26:(Suppl):8520.
87. Niesvizky R, Jayabalan DS, Christos PJ, et al. BiRD (Biaxin [clarithromycin]/Revlimid [lenalidomide]/dexamethasone) combination therapy results in high complete- and overall-response rates in treatment-naive symptomatic multiple myeloma. Blood. 2008;111:1101-1109. (Pubitemid 351213388)
88. Mark T, Jayabalan D, Pearse RN, et al. Atypical serum immunofixation pattern (ASIP) development during induction therapy with BiRD for newly diagnosed multiple myeloma correlates with a high rate of complete remission [abstract]. Blood. 2007;110:2737.
89. Palumbo AP, Falco T, Corradini P, et al. Bortezomib, pegylated-lyposomal- doxorubicin and dexamethasone (PAD) as induction therapy prior to reduced intensity autologous stem cell transplant (ASCT) followed by lenalidomide and prednisone (LP) as consolidation and lenalidomide alone as maintenance [abstract]. J Clin Oncol. 2008;26(Suppl):8518.
90. Rajkumar SV, Jacobus S, Callander N, et al. A randomized trial of lenalidomide plus high-dose dexamethasone (RD) versus lenalidomide plus low-dose dexamethasone (Rd) in newly diagnosed multiple myeloma (E4A03): a trial coordinated by the Eastern Cooperative Oncology Group [abstract]. Blood. 2007;110:74.
91. Zonder JA, Crowley JJ, Bolejack V, et al. A randomized Southwest Oncology Group study comparing dexamethasone (D) to lenalidomide + dexamethasone (LD) as treatment of newly-diagnosed multiple myeloma (NDMM): Impact of cytogenetic abnormalities on efficacy of LD, and updated overall study results [abstract]. J Clin Oncol. 2008;26:(Suppl):8521.
92. Palumbo A, Falco P, Corradini P, et al. Melphalan, prednisone and lenalidomide for newly diagnosed myeloma: kinetics of neutropenia/ thrombocytopenia and time to event results [abstract]. Haematologica. 2008;93(Suppl 1):0213.
93. Kumar S, Dispenzieri A, Lacy MQ, et al. Impact of lenalidomide therapy on stem cell mobilization and engraftment post-peripheral blood stem cell transplantation in patients with newly diagnosed myeloma. Leukemia. 2007;21:2035-2042. (Pubitemid 47299979)
94. Paripati H, Stewart AK, Fonseca R, et al. Impact of lenalidomide therapy on stem cell mobilization in myeloma [abstract]. J Clin Oncol. 2008;26(Suppl):8543.
95. Cook RJ, Vogl D, Mangan PA, et al. Lenalidomide and stem cell collection in patients with multiple myeloma [abstract]. J Clin Oncol. 2008;26(Suppl):8547.
96. Mark T, Stern J, Furst J, et al. Stem cell mobilization with cylophosphamide overcomes the suppressive effect of lenalidomide therapy on stem cell collection in multiple myeloma. Biol Blood Marrow Transplant. 2008;14:795-798. (Pubitemid 351773154)
97. Weber D, Knight R, Chen C, et al. Prolonged overall survival with lenalidomide plus dexamethasone compared with dexamethasone alone in patients with relapsed or refractory multiple myeloma [abstract]. Blood. 2007;110:412.
98. Harousseau J-L, Weber D, Dimopoulos M, et al. Relapsed/refractory multiple myeloma patients treated with lenalidomide/dexamethasone who achieve a complete or near complete response have longer overall survival and time to progression compared with patients achieving a partial response [abstract]. Blood. 2007;110:3598.
99. Wang M, Knight R, Dimopoulos D, et al. Effect of Len/Dex in MM despite Thal resistance [abstract]. Haematol Hematol J Haematologica. 2007;92(s2):6 Suppl 2):PO-662.
100. Stadtmauer E, Weber D, Dimopoulos M, et al. Lenalidomide in combination with dexamethasone is more effective than dexamethasone at first relapse in relapsed multiple myeloma [abstract]. Blood. 2006;108:3552.
101. Foa R, Weber D, Dimopoulos M, et al. Lenalidomide/dexamethasone improves response and prolongs time to progression, even in patients with IgA multiple myeloma: a sub-analysis of the MM-009/010 studies [abstract]. Blood. 2007;110:4839.
102. Chanan-Khan AA, Dimopoulos M, Weber D, et al. ECOG performance status affects efficacy, but not safety, of lenalidomide/dexamethasone in relapsed/refractory multiple myeloma (MM009/010 sub-analysis) [abstract]. Blood. 2007;110:2721.
103. Lonial S, Knight R, Dimopoulos M, et al. Effect of Len/Dex in MM in different age groups. Haematologica. 2007;92(6 Suppl 2):PO-663.
104. Weber DM, Spencer A, Wang M, et al; MM-009 and MM-010 Investigators. The efficacy and safety of lenalidomide plus dexamethasone in relapsed or refractory multiple myeloma patients with impaired renal function [abstract]. J Clin Oncol. 2008;26(Suppl):8542.
105. San Miguel JF, Dimopoulos M, Weber D, et al. Dexamethasone dose adjustments seem to result in better efficacy and improved tolerability in patients with relapsed/refractory multiple myeloma who are treated with lenalidomide/dexamethasone (MM-009/010 sub-analysis) [abstract]. Blood. 2007;110:2712.
106. Kneppers E, Lokhorst HM, Eeltink C, et al. Pretreatment with thalidomide and bortezomib does not influence response to lenalidomide in relapsed myeloma. Preliminary results from patients included in Dutch compassionate need programme [abstract]. Haematologica. 2008;93(Suppl 1):0651.
107. Richardson PG, Blood E, Mitsiades CS, et al. A randomized phase 2 study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma. Blood. 2006;108:3458-3464.
108. Jagannath S, Richardson PG, Zeldenrust S, et al. Long-term responses observed with lenalidomide therapy for patients with relapsed or refractory multiple myeloma [abstract]. J Clin Oncol. 2008;26(Suppl):8525.
109. Richardson P, Sonneveld P, Schuster M, et al. Bortezomib continues to demonstrate superior efficacy compared with high-dose dexamethasone in relapsed multiple myeloma: updated results of the APEX trial [abstract]. Blood. 2005;106:2547.
110. Richardson PG, Jagannath S, Avigan DE, et al. Lenalidomide plus bortezomib (Rev-Vel) in relapsed and/or refractory multiple myeloma (MM): final results of a multicenter phase 1 trial [abstract]. Blood. 2006;108:405.
111. Richardson P, Jagannanth S, Hussein M, et al. Safety and efficacy of single-agent lenalidomide in patients with relapsed and refractory multiple myeloma. Blood. 2009;114:772-778.
112. Hussein MA, Richardson PG, Jagannath S, et al. Final analysis of MM-014: single-agent lenalidomide in patients with relapsed and refractory multiple myeloma [abstract]. J Clin Oncol. 2008;26(Suppl):8524.
113. Richardson PG, Schlossman RL, Weller E, et al. Immunomodulatory drug CC-5013 overcomes drug resistance and is well tolerated in patients with relapsed multiple myeloma. Blood. 2002;100:3063-3067. (Pubitemid 35217050)
114. Baz R, Walker E, Karam MA, et al. Lenalidomide and pegylated liposomal doxorubicin-based chemotherapy for relapsed or refractory multiple myeloma: safety and efficacy. Ann Oncol. 2006;17:1766-1771. (Pubitemid 44884050)
115. Morgan GJ, Schey SA, Wu P, et al. Lenalidomide (Revlimid), in combination with cyclophosphamide and dexamethasone (RCD), is an effective and tolerated regimen for myeloma patients. Br J Haematol. 2007;137:268-269. (Pubitemid 46537629)
116. Knop S, Gerecke C, Liebisch P, et al. The efficacy and toxicity of the RAD regimen (Revlimid®, Adriamycin®, dexamethasone) in relapsed and refractory multiple myeloma - a phase I/II trial of "Deutsche Studiengruppe Multiples Myelom" [abstract]. Blood. 2007;110:2716.
117. Knop S, Gerecke C, Liebisch P, et al. Results of a phase I/II trial of Deutsche Studiengruppe Multiples Myelom, showing efficacy and safety of RAD regimen (Revlimid®, Adriamycin®, dexamethasone) in relapsed/refractory multiple myeloma [abstract]. Haematologica. 2008;93(Suppl 1):0637.
118. Reece DE, Masih-Khan E, Chen C, et al. Lenalidomide (Revlimid®) +/- corticosteroids in elderly patients with relapsed/refractory multiple myeloma [abstract]. Blood. 2006;108:1013a-1014a, #. 3550.
119. Anderson KC, Jagannath S, Jakubowiak A, et al. Phase II study of lenalidomide (Len), bortezomib (Bz), and dexamethasone (Dex) in patients (pts) with relapsed or relapsed and refractory multiple myeloma (MM) [abstract]. J Clin Oncol. 2008;26(Suppl):8545.
120. Terpos E, Christoulas D, Kastritis E, et al. Effect of lenalidomide-based regimens on bone remodeling in patients with relapsed/refractory multiple myeloma [abstract]. Haematologica. 2008;93(Suppl 1):0192.
121. Raschko M, Markovina S, Miyamoto S, et al. Phase II trial of bevacizumab combined with low dose dexamethasone and lenalidomide (Bev/Rev/Dex) for relapsed or refractory myeloma (MM) [abstract]. Blood. 2007;110:1173.
122. Palumbo A, Falco P, Sanpaolo G, et al. Lenalidomide, melphalan, prednisone and thalidomide (RMPT) for relapsed/refractory multiple myeloma [abstract]. Haematologica. 2008;93(Suppl 1):0636.
123. Stadtmauer EA, Lonial S, Vesole DH, et al. A practical guide to achieving and maintaining the best response to lenalidomide in multiple myeloma: roundtable proceedings. Clin Adv Hematol Oncol. 2007;5(10 Suppl 15):7-19.
124. Morgan J, Ishak K, Deniz B, et al. Overall survival with dexamethasone in phase III multiple myeloma trials after adjustment for cross-over to lenalidomide [abstract]. Haematologica. 2008;93(Suppl 1):0441.
125. Bahlis NJ, Song K, Trieu Y, et al. Lenalidomide overcomes poor prognosis conferred by del13q and t(4;14) but not del17p13 in multiple myeloma: results of the Canadian MM016 trial [abstract]. Blood. 2007;110:3597.
126. Zangari M, Fink L, Knight R, et al. Effect on survival of lenalidomide and dexamethasone associated deep vein thrombosis (DVT) in relapsed multiple myeloma patients [abstract]. Haematologica. 2008;93(Suppl 1):0638.
127. Niesvizky R, Spencer A, Wang M, et al. Increased risk of thrombosis with lenalidomide in combination with dexamethasone and erythropoietin [abstract]. J Clin Oncol. 2006;24:(Suppl):7506.
128. Chen C, Reece DE, Siegel D, et al. Expanded Access Program (EAP) for lenalidomide (Revlimid®) plus dexamethasone in over 1400 subjects with relapsed or refractory multiple myeloma [abstract]. Blood. 2006;108:3556.
129. Niesvizky R, Naib T, Christos PJ, et al. Lenalidomide-induced myelosuppression is associated with renal dysfunction: adverse events evaluation of treatment-naïve patients undergoing front-line lenalidomide and dexamethasone therapy. Br J Haematol. 2007;138:640-643. (Pubitemid 47206719)
130. Simpson L, Rajkumar SV, Dispenzieri A, et al. High incidence of diarrhea in patients on long term therapy with lenalidomide and dexamethasone for multiple myeloma [abstract]. J Clin Oncol. 2008;26(Suppl):8586.
131. Bennett CL, Hussain Z, Courtney M, Yarnold P, Raisch D, McKoy JM. RADAR update on thalidomide (Thal)- and lenalidomide (Len)-associated venous thromboembolism (VTE): safety concerns persist for multiple myeloma (MM) despite FDA approvals in this setting [abstract]. Blood. 2006;108:3310.
132. Angelotta C, Lurie AJ, Yarnold PR, et al. Black box warning on lenalidomide-associated venous thromboembolism (VTE) in off-label setting: A preemptive and unusual safety initiative [abstract]. J Clin Oncol. 2006;24:(Suppl):6074.
133. Fullerton DSP, Trautman H, Huang H, et al. A budget impact model comparing resource utilization of four approved therapies for multiple myeloma (MM) in the US [abstract]. Blood. 2007;110:3324.
134. Armoiry X, Fagnani F, Benboubker L, et al. Estimating direct costs of care for patients with relapsed or refractory multiple myeloma in French hospitals [abstract]. J Clin Oncol. 2008;26(Suppl):8596.
135. Deniz HB, Ishak KJ, Edwards DR, Shearer A, Dale P, Caro JJ. Economic evaluation of lenalidomide for the treatment of multiple myeloma in Wales in patients who have received at least one prior therapy [abstract]. Haematologica. 2008;93(Suppl 1):0804.
136. Chanan-Khan AA, Weber D, Dimopoulos M, et al. Lenalidomide (L) in combination with dexamethasone (D) improves survival and time to progression in elderly patients (pts) with relapsed or refractory (rel/ref) multiple myeloma (MM) [abstract]. Blood. 2006a;108:3551.
137. Chanan-Khan AA, Yu Z, Weber D, et al. Lenalidomide (L) in combination with dexamethasone (D) significantly improves time to progression (TTP) in non-stem cell transplant patients (pts) with relapsed or refractory (rel/ref)
138. Anon. Revlimid (lenalidomide) Prescribing information. 2008. Available from: http://www.revlimid.com/pdf/REVLIMID-PI.pdf. Accessed October 2, 2008.
139. Zonder JA, Durie BG, McCoy J, et al. High incidence of thrombotic events observed in patients receiving lenalidomide (L) + dexamethasone (D) (LD) as first-line therapy for multiple myeloma (MM) without aspirin (ASA) prophylaxis [abstract]. Blood. 2005;106:3455.
140. Richardson RG, Mitsiades C, Schlossman R, et al. New drugs for myeloma. Oncologist. 2007;12:664.