A phase 1, multicenter, open-label, dose escalation study of elotuzumab in patients with advanced multiple myeloma

Blood

Volumn 120, Issue 3, 2012, Pages 552-559

  Zonder, Jeffrey A ^a   Mohrbacher, Ann F ^b   Singhal, Seema ^c   Van Rhee, Frits ^d   Bensinger, William I ^e   Ding, Han ^f   Fry, John ^f   Afar, Daniel E H ^f   Singhal, Anil K ^f  

^a WAYNE STATE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b UNIVERSITY OF SOUTHERN CALIFORNIA   (United States)

^c NORTHWESTERN UNIVERSITY   (United States)

^d UNIVERSITY OF ARKANSAS FOR MEDICAL SCIENCES   (United States)

^e Fred Hutchinson Cancer Research Center   (United States)

^f Abbott Biotherapeutics Corp   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CORTICOSTEROID; CREATININE; ELOTUZUMAB;

ACUTE KIDNEY FAILURE; ADULT; ADVANCED CANCER; AGED; ANOREXIA; ARTICLE; BACKACHE; BONE MARROW CELL; CANCER RELAPSE; CHILL; CLINICAL ARTICLE; COUGHING; CREATININE BLOOD LEVEL; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DOSE COMPARISON; DRUG DOSE ESCALATION; DRUG DOSE INCREASE; DRUG EFFICACY; DRUG HALF LIFE; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG SAFETY; DYSPNEA; FEMALE; FEVER; FLUSHING; HUMAN; IMMUNOGENICITY; MALE; MAXIMUM TOLERATED DOSE; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE MYELOMA; PHASE 1 CLINICAL TRIAL; PRIORITY JOURNAL; SIDE EFFECT; SINUS TACHYCARDIA; THORAX PAIN; TREATMENT RESPONSE; VOMITING;

EID: 84864118302     PISSN: 00064971     EISSN: 15280020     Source Type: Journal    
DOI: 10.1182/blood-2011-06-360552     Document Type: Article

References (41)

1. Kyle RA, Rajkumar SV. Multiple myeloma. N Engl J Med. 2004;351(18):1860-1873.
2. Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010;60(5):277-300.
3. Altekruse SF, Kosary CL, Krapcho M, et al. SEER Cancer Statistics Review, 1975-2007. Bethesda, MD: National Cancer Institute; Available at: http://seer.cancer.gov/csr/1975-2007. Based on November 2009 SEER data submission, posted to the SEER website, 2010. Accessed April 13, 2011.
4. Alexander DD, Mink PJ, Adami H-O, et al. Multiple myeloma: a review of the epidemiologic literature. Int J Cancer. 2007;120(Suppl 12):40-61. (Pubitemid 46766474)
5. Kumar SK, Rajkumar SV, Dispenzieri A, et al. Improved survival in multiple myeloma and the impact of novel therapies. Blood. 2008;111(5):2516- 2520.
6. Turesson I, Velez R, Kristinsson SY, Landgren O. Patterns of improved survival in patients with multiple myeloma in the twenty-first century: a population-based study. J Clin Oncol. 2010;28(5):830-834.
7. Barlogie B, Attal M, Crowley J, et al. Long-term follow-up of autotransplantation trials for multiple myeloma: update of protocols conducted by the Intergroupe Francophone du Myelome, Southwest Oncology Group, and University of Arkansas for Medical Sciences. J Clin Oncol. 2010;28(7):1209-1214.
8. San Miguel JF, Schlag R, Khuageva NK, et al. Bortezomib plus melphalan and prednisone for initial treatment of multiple myeloma. N Engl J Med. 2008;359(9):906-917.
9. Rajkumar SV, Jacobus S, Callander NS, et al. 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(1):29-37.
10. Zonder JA, Crowley J, Hussein MA, et al. Lenalidomide and high-dose dexamethasone compared with dexamethasone as initial therapy for multiple myeloma: a randomized Southwest Oncology Group trial (S0232). Blood. 2010;116(26):5838-5841.
11. 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.
12. Morgan GJ, Davies FE, Gregory WM, et al. Cyclophosphamide, thalidomide, and dexamethasone (CTD) as initial therapy for patients with multiple myeloma unsuitable for autologous transplantation. Blood. 2011;118(5):1231-1238.
13. Richardson PG, Weller E, Lonial S, et al. Lenalidomide, bortezomib, and dexamethasone combination therapy in patients with newly diagnosed multiple myeloma. Blood. 2010;116(5):679-686.
14. Weber DM, Chen C, Niesvizky R, et al. Lenalidomide plus dexamethasone for relapsed multiple myeloma in North America. N Engl J Med. 2007; 357(21):2133-2142. (Pubitemid 350146108)
15. Dimopoulos M, Spencer A, Attal M, et al. Lenalidomide plus dexamethasone for relapsed or refractory multiple myeloma. N Engl J Med. 2007; 357(21):2123-2132. (Pubitemid 350146107)
16. Kumar SK, Lee JH, Lahuerta JJ, et al. Risk of progression and survival in multiple myeloma relapsing after therapy with IMiDs and bortezomib: a multicenter international myeloma working group study. Leukemia. 2012;26(1):149-157.
17. Hsi ED, Steinle R, Balasa B, et al. CS1, a potential new therapeutic antibody target for the treatment of multiple myeloma. Clin Cancer Res. 2008;14(9):2775-2784.
18. Tai Y-T, Dillon M, Song W, et al. Anti-CS1 humanized monoclonal antibody HuLuc63 inhibits myeloma cell adhesion and induces antibody-dependent cellular cytotoxicity in the bone marrow milieu. Blood. 2008;112(4):1329-1337.
19. van Rhee F, Szmania SM, Dillon M, et al. Combinatorial efficacy of anti-CS1 monoclonal antibody elotuzumab (HuLuc63) and bortezomib against multiple myeloma. Mol Cancer Ther. 2009;8(9):2616-2624.
20. Durie BGM, Harousseau J-L, Miguel JS, et al. International uniform response criteria for multiple myeloma. Leukemia. 2006;20(9):1467-1473. (Pubitemid 44264086)
21. Mire-Sluis AR, Barrett YC, Devanarayan V, et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J Immunol Methods. 2004;289(1):1-16. (Pubitemid 38900899)
22. Coiffier B, Lapage E, Briere J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med. 2002;346(4):235-242. (Pubitemid 34438862)
23. Kaminski MS, Tuck M, Estes J, et al. 131I-tositumomab therapy as initial treatment for follicular lymphoma. N Engl J Med. 2005;352(5): 441-449. (Pubitemid 40175970)
24. Wierda WG, Padmanabhan S, Chan GW, et al. Ofatumumab is active in patients with fludarabine-refractory CLL irrespective of prior rituximab: results from the phase II international study. Blood. 2011;118(19):5126-5129.
25. Osterborg A, Dyer MJ, Bunjes D, et al. Phase II multicenter study of human CD52 antibody in previously treated chronic lymphocytic leukemia: European Study Group of CAMPATH-1H Treatment in Chronic Lymphocytic Leukemia. J Clin Oncol. 1997;15(4):1567-1574. (Pubitemid 27167394)
26. Richardson PG, Lonial S, Jakubowiak AJ, et al. Monoclonal antibodies in the treatment of multiple myeloma. Br J Haematol. 2011;154:745-754.
27. Zojer N, Kirchbacher K, Vesely M, et al. Rituximab treatment provides no clinical benefit in patients with pretreated advanced multiple myeloma. Leuk Lymphoma. 2006;47(6):1103- 1109.
28. Kapoor P, Greipp PT, Morice WG, et al. Anti-CD20 monoclonal antibody therapy in multiple myeloma. Br J Haematol. 2008;141(2):135-148. (Pubitemid 351406208)
29. Tai YT, Catley LP, Mitsiades CS, et al. Mechanisms by which SGN-40, a humanized anti-CD40 antibody, induces cytotoxicity in human multiple myeloma cells: clinical implications. Cancer Res. 2004;64(8):2846-2852. (Pubitemid 38500624)
30. Tai YT, Li X, Tong X, et al. Human anti-CD40 antagonist antibody triggers significant anti-tumor activity against human multiple myeloma. Cancer Res. 2005;65(13):5898-5906. (Pubitemid 40911196)
31. Agura E, Niesvizky R, Matous J, et al. Dacetuzumab (SGN-40), lenalidomide, and weekly dexamethasone in relapsed or refractory multiple myeloma: multiple responses observed in a phase 1b study [abstract]. Blood (ASH Annual Meeting Abstracts). 2009;114a. Abstract 2870.
32. Lutz RJ, Whiteman KR. Antibody- maytansinoid conjugates for the treatment of myeloma. MAbs. 2009;1(6):548-551.
33. Stevenson GT. CD38 as a therapeutic target. Mol Med. 2006;12(11):345-346. (Pubitemid 46489831)
34. Tassone P, Goldmacher VS, Neri P, et al. Cytotoxic activity of the maytansinoid immunoconjugate B-B4-DM1 against CD138+ multiple myeloma cells. Blood. 2004;104(12):3688-3696. (Pubitemid 39564446)
35. Vij R, Horvath N, Spencer A, et al. An open-label, phase 2 trial of denosumab in the treatment of relapsed or plateau-phase multiple myeloma. Am J Hematol. 2009;84(10):650-656.
36. Voorhees PM, Chen Q, Small GW, et al. Targeted inhibition of interleukin-6 with CNTO 328 sensitizes pre-clinical models on multiple myeloma to dexamethasone-mediated cell death. Br J Haematol. 2009;145(4):481-490.
37. Collins SM, Bakan CE, Alghothani Y, et al. The effect of elotuzumab on natural killer (NK) cell function against multiple myeloma (MM) [abstract]. J Clin Oncol (ASCO Annual Meeting Abstracts). 2011;29a. Abstract 2572.
38. Lonial S, Vij R, Harousseau J-L, et al. Phase 1/2 study of elotuzumab in combination with lenalidomide and low dose dexamethasone in relapsed or refractory multiple myeloma: interim results [abstract]. Blood (ASH Annual Meeting Abstracts). 2009;114a. Abstract 432.
39. Jakubowiak AJ, Benson DM Jr, Bensinger W, et al. Elotuzumab in combination with bortezomib in patients with relapsed/refractory multiple myeloma: updated results of a phase 1 study [abstract]. Blood (ASH Annual Meeting Abstracts). 2010;116a. Abstract 3023.
40. Lonial S, Vij R, Harousseau J-L, et al. Elotuzumab in combination with lenalidomide and low-dose dexamethasone in patients with relapsed/ refractory multiple myeloma: results of a phase 1 study [abstract]. Blood. (ASH Annual Meeting Abstracts). 2010;116a. Abstract 1936.
41. Richardson PG, Moreau P, Jakubowiak AJ, et al. Elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma: interim results of a phase 2 study [abstract]. Blood (ASH Annual Meeting Abstracts). 2010;116a. Abstract 986.