Multicenter, phase I, dose-escalation trial of lenalidomide plus bortezomib for relapsed and relapsed/refractory multiple myeloma

Journal of Clinical Oncology

Volumn 27, Issue 34, 2009, Pages 5713-5719

  Richardson, Paul G ^a   Weller, Edie ^a   Jagannath, Sundar ^a   Avigan, David E ^a   Alsina, Melissa ^a   Schlossman, Robert L ^a   Mazumder, Amitabha ^a   Munshi, Nikhil C ^a   Ghobrial, Irene M ^a   Doss, Deborah ^a   Warren, Diane L ^a   Lunde, Laura E ^a   McKenney, Mary ^a   Delaney, Carol ^a   Mitsiades, Constantine S ^a   Hideshima, Teru ^a   Dalton, William ^a   Knight, Robert ^a   Esseltine, Dixie Lee ^a   Anderson, Kenneth C ^a  

^a H LEE MOFFITT CANCER CENTER AND RESEARCH INSTITUTE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BORTEZOMIB; DEXAMETHASONE; LENALIDOMIDE; ANTINEOPLASTIC AGENT; BORONIC ACID DERIVATIVE; DRUG DERIVATIVE; GLUCOCORTICOID; PYRAZINE DERIVATIVE; THALIDOMIDE;

ADULT; AGED; ANEMIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER SURVIVAL; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DISEASE COURSE; DOSE RESPONSE; DRUG DOSE ESCALATION; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HERPES ZOSTER; HUMAN; HYPONATREMIA; LEUKOPENIA; MALE; MAXIMUM PERMISSIBLE DOSE; MAXIMUM TOLERATED DOSE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; NEUTROPENIA; OVERALL SURVIVAL; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; RECURRENT DISEASE; THROMBOCYTOPENIA; TOXICITY; DRUG RESISTANCE; MIDDLE AGED; PATHOLOGY;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BORONIC ACIDS; DEXAMETHASONE; DRUG RESISTANCE, NEOPLASM; FEMALE; GLUCOCORTICOIDS; HUMANS; MALE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; MULTIPLE MYELOMA; PYRAZINES; RECURRENCE; THALIDOMIDE;

EID: 73349115580     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2009.22.2679     Document Type: Article

References (38)

1. Jemal A, Siegel R, Ward E, et al: Cancer Statistics, 2008. CA Cancer J Clin 58:71-96, 2008
2. Richardson PG, Mitsiades C, Schlossman R, et al: New drugs for myeloma. Oncologist 12:664-689, 2007
3. Weber DM, Chen C, Niesvizky R, et al: Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med 357:2133-2142, 2007
4. Dimopoulos M, Spencer A, Attal M, et al: Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med 357: 2123-2132, 2007
5. Richardson PG, Sonneveld P, Schuster MW, et al: Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med 352:2487-2498, 2005
6. 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 110:3557-3560, 2007
7. San Miguel JF, Schlag R, Khuageva NK, et al: Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med 359:906-917, 2008
8. Mitsiades N, Mitsiades CS, Poulaki V, et al: Apoptotic signaling induced by immunomodulatory thalidomide analogs in human multiple myeloma cells: Therapeutic implications. Blood 99:4525-4530, 2002
9. Hideshima T, Chauhan D, Shima Y, et al: Thalidomide and its analogs overcome drug resistance of human multiple myeloma cells to conventional therapy. Blood 96:2943-2950, 2000
10. Hideshima T, Richardson P, Chauhan D, et al: The proteasome inhibitor PS-341 inhibits growth, induces apoptosis, and overcomes drug resistance in human multiple myeloma cells. Cancer Res 61: 3071-3076, 2001
11. Mitsiades N, Mitsiades CS, Richardson PG, et al: The proteasome inhibitor PS-341 potentiates sensitivity of multiple myeloma cells to conventional chemotherapeutic agents: Therapeutic applications. Blood 101:2377-2380, 2003
12. 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 100:3063-3067, 2002
13. National Cancer Institute Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events, version 3.0. http://ctep.cancer.gov/ forms/CTCAEv3.pdf
14. Cella DF, Tulsky DS, Gray G, et al: The Functional Assessment of Cancer Therapy scale: Development and validation of the general measure. J Clin Oncol 11:570-579, 1993
15. 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 102:1115-1123, 1998
16. Richardson PG, Barlogie B, Berenson J, et al: A phase II study of bortezomib in relapsed, refractory myeloma. N Engl J Med 348:2609-2617, 2003
17. Anderson KC, Kyle RA, Rajkumar SV, et al: Clinically relevant end points and new drug approvals for myeloma. Leukemia 22:231-239, 2008
18. Richardson P, Lonial S, Jakubowiak A, et al: Lenalidomide, bortezomib, and dexamethasone in patients with newly diagnosed multiple myeloma: Encouraging efficacy in high risk groups with updated results of a phase I/II study. Blood 112, 2008 (abstr 92)
19. Richardson PG, Blood E, Mitsiades CS, et al: A randomized phase II study of lenalidomide therapy for patients with relapsed or relapsed and refractory multiple myeloma. Blood 108:3458-3464, 2006
20. Bartlett JB, Dredge K, Dalgleish AG: The evolution of thalidomide and its IMiD derivatives as anticancer agents. Nat Rev Cancer 4:314-322, 2004
21. Richardson PG, Briemberg H, Jagannath S, et al: Frequency, characteristics, and reversibility of peripheral neuropathy during treatment of advanced multiple myeloma with bortezomib. J Clin Oncol 24:3113-3120, 2006
22. Berenson JR, Jagannath S, Barlogie B, et al: Safety of prolonged therapy with bortezomib in relapsed or refractory multiple myeloma. Cancer 104:2141-2148, 2005
23. Lonial S, Richardson PG, San MJ, et al: Characterisation of haematological profiles and low risk of thromboembolic events with bortezomib in patients with relapsed multiple myeloma. Br J Haematol 143:222-229, 2008
24. Jagannath S, Barlogie B, Berenson J, et al: A phase II study of two doses of bortezomib in relapsed or refractory myeloma. Br J Haematol 127: 165-172, 2004
25. Hussein MA: Thromboembolism risk reduction in multiple myeloma patients treated with immunomodulatory drug combinations. Thromb Haemost 95:924-930, 2006
26. Palumbo A, Rajkumar SV, Dimopoulos MA, et al: Prevention of thalidomide- and lenalidomide-associated thrombosis in myeloma. Leukemia 22: 414-423, 2008
27. Barlogie B, Anaissie E, Shaughnessy JD Jr, et al: Phase II study of total therapy 3 (TT3) with added bortezomib (V) for multiple myeloma (MM). J Clin Oncol 25:446s, 2007 (suppl; abstr 8020)
28. Cavo M, Tacchetti P, Patriarca F, et al: Superior complete response rate and progression-free survival after autologous transplantation with up-front Velcade-thalidomide-dexamethasone compared with thalidomide-dexamethasone in newly diagnosed multiple myeloma. Blood 112, 2008 (abstr 158)
29. Zangari M, Guerrero J, Cavallo F, et al: Coagulation-related effect of bortezomib treatment in patients with relapsed or refractory multiple myeloma. Blood 110:803a, 2007 (abstr 2733)
30. Petrucci MT, Blau IW, Corradini P, et al: Efficacy and safety of re-treatment with bortezomib in patients with multiple myeloma: Results from a prospective international phase II trial. Blood 112, 2008 (abstr 3690)
31. Wolf J, Richardson PG, Schuster M, et al: Utility of bortezomib retreatment in relapsed or refractory multiple myeloma patients: A multicenter case series. Clin Adv Hematol Oncol 6:755-760, 2008
32. Jagannath S, Richardson PG, Barlogie B, et al: Bortezomib in combination with dexamethasone for the treatment of patients with relapsed and/or refractory multiple myeloma with less than optimal response to bortezomib alone. Haematologica 91: 929-934, 2006
33. Berenson JR, Matous J, Swift RA, et al: A phase I/II study of arsenic trioxide/bortezomib/ascorbic acid combination therapy for the treatment of relapsed or refractory multiple myeloma. Clin Cancer Res 13:1762-1768, 2007
34. Palumbo A, Falco P, Corradini P, et al: Melphalan, prednisone, and lenalidomide treatment for newly diagnosed myeloma: A report from the GIMEMA-Italian Multiple Myeloma Network. J Clin Oncol 25:4459-4465, 2007
35. 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. Blood 110:32a, 2007 (abstr 77)
36. Harousseau JL, Mathiot C, Attal M, et al: Bortezomib/dexamethasone versus VAD as induction prior to autologous stem cell transplantion (ASCT) in previously untreated multiple myeloma (MM): Updated data from IFM 2005/01 trial. J Clin Oncol 26:455s, 2008 (suppl; abstr 8505)
37. Richardson P, Jagannath S, Jakubowiak A, et al: Lenalidomide, bortezomib, and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma (MM): Encouraging response rates and tolerability with correlation of outcome and adverse cytogenetics in a phase II study. Blood 112, 2008 (abstr 1742)
38. Kumar S, Flinn IW, Noga SJ, et al: Safety and efficacy of novel combination therapy with bortezomib, dexamethasone, cyclophosphamide, and lenalidomide in newly diagnosed multiple myeloma: Initial results from the phase I/II multi-center EVOLUTION study. Blood 112, 2008 (abstr 93)