Bortezomib therapy alone and in combination with dexamethasone for previously untreated symptomatic multiple myeloma

British Journal of Haematology

Volumn 129, Issue 6, 2005, Pages 776-783

  Jagannath, Sundar ^a   Durie, Brian G M ^b   Wolf, Jeffrey ^c   Camacho, Elber ^d   Irwin, David ^c   Lutzky, Jose ^e   McKinley, Marti ^f   Gabayan, Eli ^b   Mazumder, Amitabha ^a   Schenkein, David ^g   Crowley, John ^h  

^a ST VINCENT S COMPREHENSIVE CANCER CENTER   (United States)

^b CEDARS SINAI MEDICAL CENTER   (United States)

^c Alta Bates Comprehensive Cancer Center   (United States)

^d Comprehensive Cancer Center Associates ^*  (United States)

^e Miami Beach FL   (United States)

^f Aptium Oncology   (United States)

^g MILLENNIUM PHARMACEUTICALS INC   (United States)

^h Cancer Research and Biostatistics/SWOG Statistical Center   (United States)

Author keywords

Bortezomib; Dexamethasone; Multiple myeloma; Proteasome

Indexed keywords

BISPHOSPHONIC ACID DERIVATIVE; BORTEZOMIB; DEXAMETHASONE; GRANULOCYTE COLONY STIMULATING FACTOR; PARAPROTEIN;

ABDOMINAL CRAMP; ABDOMINAL PAIN; ADULT; AGED; ANOREXIA; ARTICLE; BLOOD TOXICITY; BLOOD TRANSFUSION; BONE PAIN; CLINICAL ARTICLE; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DIZZINESS; DRUG DOSE REDUCTION; DRUG DOSE REGIMEN; EDEMA; ERYTHEMA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HEADACHE; HUMAN; INSOMNIA; MALE; MONOTHERAPY; MULTICENTER STUDY; MULTIPLE MYELOMA; MUSCLE WEAKNESS; MYALGIA; PRIORITY JOURNAL; PROTEIN BLOOD LEVEL; SENSORY NEUROPATHY; STEM CELL MOBILIZATION; STEM CELL TRANSPLANTATION; THROMBOCYTOPENIA; TREATMENT OUTCOME;

AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BORONIC ACIDS; DEXAMETHASONE; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; MALE; MIDDLE AGED; MULTIPLE MYELOMA; PERIPHERAL NERVOUS SYSTEM DISEASES; PYRAZINES; STEM CELL TRANSPLANTATION; SURVIVAL ANALYSIS; TREATMENT OUTCOME;

EID: 21344469223     PISSN: 00071048     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1365-2141.2005.05540.x     Document Type: Article

References (35)

1. Alexanian, R., Barlogie, B. & Dixon, D. (1986) High-dose glucocorticoid treatment of resistant myeloma. Annals of Internal Medicine, 105, 8-11.
2. Alexanian, R., Barlogie, B. & Tucker, S. (1990) VAD-based regimens as primary treatment for multiple myeloma. American Journal of Hematology, 33, 86-89.
3. Alexanian, R., Dimopoulos, M.A., Delasalle, K. & Barlogie, B. (1992) Primary dexamethasone treatment of multiple myeloma. Blood, 80, 887-890.
4. American Cancer Society (2005) Cancer facts and figures 2005. WWW document. http://www.cancer.org/docroot/STI7STT_0.asp [last accessed 20 May 2005].
5. Attal, M., Harousseau, J.L., Stoppa, A.M., Sotto, J.J., Fuzibet, J.G., Rossi, J.F., Casassus, P., Maisonneuve, H., Facon, T., Ifrah, N., Payen, C. & Bataille, R. (1996) A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. Intergroupe Francais du Myelome. New England Journal of Medicine, 335, 91-97.
6. Attal, M., Harousseau, J.L., Facon, T., Guilhot, F., Doyen, C., Fuzibet, J.G., Monconduit, M., Hulin, C., Caillot, D., Bouabdallah, R., Voillat, L., Sotto, J.J., Grosbois, B. & Bataille, R. (2003) Single versus double autologous stem-cell transplantation for multiple myeloma. New England Journal of Medicine, 349, 2495-2502.
7. Barlogie, B., Smith, L. & Alexanian, R. (1984) Effective treatment of advanced multiple myeloma refractory to alkylating agents. New England Journal of Medicine, 310, 1353-1356.
8. Barlogie, B., Jagannath, S., Desikan, K.R., Mattox, S., Vesole, D., Siegel, D., Tricot, G., Munshi, N., Fassas, A., Singhal, S., Mehta, J., Anaissie, E., Dhodapkar, D., Naucke, S., Cromer, J., Sawyer, J., Epstein, J., Spoon, D., Ayers, D., Cheson, B. & Crowley, J. (1999) Total therapy with tandem transplants for newly diagnosed multiple myeloma. Blood, 93, 55-65.
9. Bladé, J., Samson, D., Reece, D., Apperley, J., Bjorkstrand, B., Gahrton, G., Gertz, M., Giralt, S., Jagannath, S. & Vesole, D. (1998) 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. British Journal of Haematology, 102, 1115-1123.
10. Cavenagh, J.D., Popat, P., Curry, N., Stec, J., Morris, T.C., Drake, M., Agrawal, S., Smith, P., Schenkein, D.P., Esseltine, D.L. & Oakervee, H. (2004) PAD combination therapy (PS-341/bortezomib, Adriamycin and dexamethasone) for previously untreated patients with multiple myeloma. Blood, 104, 413a.
11. Child, J.A., Morgan, G.J., Davies, F.E., Owen, R.G., Bell, S.E., Hawkins, K., Brown, J., Drayson, M.T. & Selby, P.J. (2003) High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. New England Journal of Medicine, 348, 1875-1883.
12. Durie, B.C., Kyle, R.A., Belch, A., Bensinger, W., Blade, J., Boccadoro, M., Child, J.A., Comenzo, R., Djulbegovic, B., Fantl, D., Gahrton, G., Harousseau, J.L., Hungria, V., Joshua, D., Ludwig, H., Mehta, J., Morales, A.R., Morgan, G., Nouel, A., Oken, M., Powles, R., Roodman, D., San Miguel, J., Shimizu, K., Singhal, S., Sirohi, B., Sonneveld, P., Tricot, G. & Van Ness, B. (2003) Myeloma management guidelines: a consensus report from the scientific advisors of the international myeloma foundation. Hematology Journal, 4, 379-398.
13. Harousseau, J., Attal, M., Leleu, X., Gressin, R., Hullin, C, Fuzibet, J. & Troncy, J. (2004) Bortezomib (VELCADE®) plus dexamethasone as induction treatment prior to autologous stem cell transplantation in patients with newly diagnosed multiple myeloma: preliminary results of an IFM phase II study. Blood, 104, 416a.
14. Hideshima, T., Richardson, P., Chauhan, D., Palombella, V.J., Elliott, P.J., Adams, J. & Anderson, K.C. (2001) The proteasome inhibitor PS-341 inhibits growth, induces apoptosis, and overcomes drug resistance in human multiple myeloma cells. Cancer Research, 61, 3071-3076.
15. Hideshima, T., Mitsiades, C., Akiyama, M., Hayashi, T., Chauhan, D., Richardson, P., Schlossman, R., Podar, K., Munshi, N.C., Mitsiades, N. & Anderson, K.C. (2003) Molecular mechanisms mediating antimyeloma activity of proteasome inhibitor PS-341. Blood, 101, 1530-1534.
16. International Myeloma Working Group (2003) Criteria for the classification of monoclonal gammopathies, multiple myeloma and related disorders: a report of the International Myeloma Working Group. British Journal of Haematology, 121, 749-757.
17. Jagannath, S., Richardson, P. & Barlogie, B. (2003) Phase II trials of bortezomib in combination with dexamethasone in multiple myeloma (MM): assessment of additional benefits to combination in patients with sub-optimal responses to bortezomib alone. Proceedings of the American Society of Clinical Oncology, 22, 582 (abstract 2341).
18. Jagannath, S., Barlogie, B., Berenson, J., Siegel, D., Irwin, D., Richardson, P.G., Niesvizky, R., Alexanian, R., Limentani, S.A., Alsina, M., Adams, J., Kauffman, M., Esseltine, D.L., Schenkein, D.P. & Anderson, K.C. (2004) A phase 2 study of two doses of bortezomib in relapsed or refractory myeloma. British Journal of Haematology, 127, 165-172.
19. Kumar, A., Loughran, T., Alsina, M., Durie, E.G. & Djulbegovic, B. (2003) Management of multiple myeloma: a systematic review and critical appraisal of published studies. Lancet Oncology, 4, 293-304.
20. Lonial, S., Waller, E.K., Richardson, P.G., Jagannath, S., Oriowski, R.Z., Giver, C.R., Jaye, D.L., Barlogie, B., Heffner, L.T. & Anderson, K.C. (2005) Bortezomib-associated transient and cyclical thrombocytopenia: evidence for lack of marrow cytotoxicity. Journal of Clinical Oncology, 23(Suppl. 14), 587s.
21. Ma, M.H., Yang, H.H., Parker, K., Manyak, S., Friedman, J.M., Altamirano, C., Wu, Z.Q., Borad, M.J., Frantzen, M., Roussos, E., Neeser, J., Mikail, A., Adams, J., Sjak-Shie, N., Vescio, R.A. & Berenson, J.R. (2003) The proteasome inhibitor PS-341 markedly enhances sensitivity of multiple myeloma tumor cells to chemotherapeutic agents. Clinical Cancer Research, 9, 1136-1144.
22. Mitsiades, N., Mitsiades, C.S., Poulaki, V., Chauhan, D., Richardson, P.G., Hideshima, T., Munshi, N., Treon, S.P. & Anderson, K.C. (2002) Biologic sequelae of nuclear factor-kappaB blockade in multiple myeloma: therapeutic applications. Blood, 99, 4079-4086.
23. Mitsiades, N., Mitsiades, C.S., Richardson, P.G., Poulaki, V., Tai, Y.T., Chauhan, D., Fanourakis, G., Gu, X., Bailey, C., Joseph, M., Libermann, T.A., Schlossman, R., Munshi, N.C., Hideshima, T. & Anderson, K.C. (2003) The proteasome inhibitor PS-341 potentiates sensitivity of multiple myeloma cells to conventional chemotherapeutic agents: therapeutic applications. Blood, 101, 2377-2380.
24. Myeloma Trialists' Collaborative Group (1998) Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. Journal of Clinical Oncology, 16, 3832-3842.
25. National Cancer Institute (1999) National Cancer Institute Cancer Therapy Evaluation Program Common Toxicity Criteria, Version 2.0. WWW document. URL: http://ctep.cancer.gov/forms/ CTCv20_4-30-992. pdf [accessed on 20 May 2005].
26. Orlowski, R.Z. (2004) Bortezomib and its role in the management of patients with multiple myeloma. Expert Review of Anticancer Therapy, 4, 171-179.
27. Rajkumar, S.V., Hayman, S., Gertz, M.A., Dispenzieri, A., Lacy, M.Q., Greipp, P.R., Geyer, S., Iturria, N., Fonseca, R., Lust, J.A., Kyle, R.A. & Witzig, T.E. (2002) Combination therapy with thalidomide plus dexamethasone for newly diagnosed myeloma. Journal of Clinical Oncology, 20, 4319-4323.
28. Rajkumar, S.V., Blood, E., Vesole, D.H., Shepard, R. & Greipp, P.R. (2004) A randomised phase III trial of thalidomide plus dexamethasone versus dexamethasone in newly diagnosed multiple myeloma (E1A00): a trial coordinated by the Eastern Cooperative Oncology Group. Journal of Clinical Oncology, 22(Suppl. 14S), 560s.
29. Richardson, P.G., Barlogie, B., Berenson, J., Singhal, S., Jagannath, S., Irwin, D., Rajkumar, S.V., Srkalovic, G., Alsina, M., Alexanian, R., Siegel, D., Orlowski, R.Z., Kuter, D., Limentani, S.A., Lee, S., Hideshima, T., Esseltine, D.L., Kauffman, M., Adams, J., Schenkein, D.P. & Anderson, K.C. (2003) A phase 2 study of bortezomib in relapsed, refractory myeloma. New England Journal of Medicine, 348, 2609-2617.
30. Richardson, P.G., Barlogie, B., Berenson, J., Singhal, S., Jagannath, S., Irwin, D., Rajkumar, S.V., Srkalovic, G., Alsina, M., Alexanian, R., Siegel, D., Orlowski, R., Kuter, D., Hideshima, T., Esseltine, D.L. & Anderson, K.C. (2004a) Survival, duration of response, and time to progression with bortezomib in patients with relapsed and refractory multiple myeloma: an update with additional follow-up. Hematology Journal, 5(Suppl. 2), S103-S104.
31. Richardson, P., Sonneveld, P., Schuster, M., Irwin, D., Stadtmauer, E., Facon, T., Harousseau, J., Ben-Yehuda, D., Lonial, S., Goldschmidt, H., Reece, D., San Miguel, J., Blade, J., Boccadoro, M., Cavenagh, J., Dalton, W., Boral, A., Schenkein, D. & Anderson, K. (2004b) Bortezomib demonstrates superior efficacy to high-dose dexamethasone in relapsed multiple myeloma: final report of the APEX study. www document. URL: http://www.abstracts2view.com/hem_ sandiego2004/. (Abstract 336.5).
32. Segeren, C.M., Sonneveld, P., van Der, H.B., Baars, J.W., Biesma, D.H., Cornellissen, J.J., Croockewit, A.J., Dekker, A.W., Fibbe, W.E., Lowenberg, B., van Marwijk, K.M., van Oers, M.H., Richel, D.J., Schouten, H.C., Vellenga, E., Verhoef, G.E., Wijermans, P.W., Wittebol, S. & Lokhorst, H.M. (1999) Vincristine, doxorubicin and dexamethasone (VAD) administered as rapid intravenous infusion for first-line treatment in untreated multiple myeloma. British Journal of Haematology, 105, 127-130.
33. Segeren, C.M., Sonneveld, P., van Der, H.B., Vellenga, E., Croockewit, A.J., Verhoef, G.E., Cornelissen, J.J., Schaafsma, M.R., van Oers, M.H., Wijermans, P.W., Fibbe, W.E., Wittebol, S., Schouten, H.C., van Marwijk, K.M., Biesma, D.H., Baars, J.W., Slater, R., Steijaert, M.M., Buijt, I. & Lokhorst, H.M. (2003) Overall and event-free survival are not improved by the use of myeloablative therapy following intensified chemotherapy in previously untreated patients with multiple myeloma: a prospective randomized phase 3 study. Blood, 101, 2144-2151.
34. Simon, R. (1989) Optimal two-stage designs for phase II clinical trials. Controlled Clinical Trials, 10, 1-10.
35. Weber, D., Rankin, K., Gavino, M., Delasalle, K. & Alexanian, R. (2003) Thalidomide alone or with dexamethasone for previously untreated multiple myeloma. Journal of Clinical Oncology, 21, 16-19.