A randomised comparison of melphalan with prednisone or dexamethasone as induction therapy and dexamethasone or observation as maintenance therapy in multiple myeloma: NCIC CTG MY.7

British Journal of Haematology

Volumn 136, Issue 2, 2007, Pages 203-211

  Shustik, Chaim ^a   Belch, Andrew ^b   Robinson, Sue ^c   Rubin, Sheldon H ^d   Dolan, Sean P ^e   Kovacs, Michael J ^f   Grewal, Kuljit S ^g   Walde, David ^h   Barr, Robert ^f   Wilson, Jonathan ⁱ   Gill, Kulwant ^j   Vickars, Linda ^k   Rudinskas, Leona ⁱ   Sicheri, Dolores A ^l   Wilson, Kenneth ^j   Djurfeldt, Marina ^m   Shepherd, Lois E ^m,n   Ding, Keyue ^m   Meyer, Ralph M ^m  

^a ROYAL VICTORIA HOSPITAL   (Canada)

^b CROSS CANCER INSTITUTE   (Canada)

^c QUEEN ELIZABETH II HEALTH SCIENCES CENTRE   (Canada)

^d MONCTON HOSPITAL   (Canada)

^e Atlantic Health Sciences Corporation   (Canada)

^f LONDON HEALTH SCIENCES CENTRE   (Canada)

^g Health Sciences Centre St John's   (Canada)

^h Sault Area Hospitals   (Canada)

ⁱ Humber Memorial Hospital   (Canada)

^j BRITISH COLUMBIA CANCER AGENCY   (Canada)

^k Burrard Medical Building ^*  (Canada)

^l Centre Regional De Cancerologie De Windsor   (Canada)

^m Queen's Cancer Research Institute   (Canada)

ⁿ QUEEN S UNIVERSITY   (Canada)

more..

Author keywords

Chemotherapy; Clinical trials; Multiple myeloma

Indexed keywords

CIPROFLOXACIN; CORTICOSTEROID; COTRIMOXAZOLE; DEXAMETHASONE; MELPHALAN; PREDNISONE;

ADULT; AGED; ARTICLE; BLOOD TOXICITY; CANCER CHEMOTHERAPY; CANCER SURVIVAL; CANCER THERAPY; CLINICAL OBSERVATION; CLINICAL TRIAL; COMPARATIVE STUDY; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DISEASE FREE SURVIVAL; DRUG DOSE ESCALATION; DRUG EFFICACY; FEMALE; HAZARD RATIO; HUMAN; HYPERGLYCEMIA; INFECTION; MAINTENANCE THERAPY; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; NEUTROPENIA; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; THROMBOCYTOPENIA; TREATMENT OUTCOME;

ADMINISTRATION, ORAL; ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DEXAMETHASONE; DRUG ADMINISTRATION SCHEDULE; FEMALE; GLUCOCORTICOIDS; HUMANS; MALE; MELPHALAN; MIDDLE AGED; MULTIPLE MYELOMA; PREDNISONE; PROPORTIONAL HAZARDS MODELS; REMISSION INDUCTION; SURVIVAL RATE; TREATMENT OUTCOME;

EID: 33845899121     PISSN: 00071048     EISSN: 13652141     Source Type: Journal    
DOI: 10.1111/j.1365-2141.2006.06405.x     Document Type: Article

References (24)

1. Alexanian, R., Dimopoulos, M.A., Delasalle, K. & Barlogie, B. (1992) Primary dexamethasone treatment of multiple myeloma. Blood, 80, 887-890.
2. 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. & The Intergroupe Francais du Myelome (1996) A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. The New England Journal of Medicine, 335, 91-97.
3. Attal, M., Harousseau, J.L., Leyvraz, S., Doyen, C., Hulin, C., Benboubker, L., Agha, I.Y., Bourhis, J.-H., Garderet, L., Sotto, J.-J., Michallet, M., Renaud, M., Voillat, L., Berthou, C., Marit, G., Monconduit, M., Dumonté, C., Caillot, D., Mathiot, C., Avet-Loiseau, H. & for the IFM (2005) Maintenance treatment with thalidomide after autologous transplantation for myeloma: final analysis of a prospective randomized study of the "Intergroupe Francophone du Myelome. Blood, 106 (Number 11, Part 1): 335a. (abstract 1148).
4. Barlogie, B., Tricot, G., Anaissie, E., Shaughnessy, J., Rasmussen, E., van Rhee, F., Fassas, A., Zangari, M., Hollmig, K., Pineda-Roman, M., Lee, C., Talamo, G., Thertulien, R., Kiwan, E., Krishna, S., Fox, M. & Crowley, J. (2006) Thalidomide and hematopoietic-cell transplantation for multiple myeloma. The New England Journal of Medicine, 354, 1021-1030.
5. Belch, A., Shelley, W., Bergsagel, D., Wilson, K., Klimo, P., White, D. & Willan, A. (1988) A randomized trial of maintenance versus no maintenance melphalan and prednisone in responding multiple myeloma patients. British Journal of Cancer, 57, 94-99.
6. Berenson, J.R., Crowley, J.J., Grogan, T.M., Zangmeister, J., Briggs, A.D., Mills, G.M., Barlogie, B. & Salmon, S.E. (2002) Maintenance therapy with alternate-day prednisone improves survival in multiple myeloma patients. Blood, 99, 3163-3168.
7. Byar, D., Schoenfeld, D., Green, S., Amato, D., Davis, R., DeGrattola, V., Finklestein, D., Gatsonis, C., Gelber, R., Lagakos, S., Lefkopoulou, M., Tsiatis, A., Zelen, M., Peto, J., Freedman, L., Gail, M., Simon, R., Ellenberg, S., Anderson, J., Collins, R., Peto, R. & Peto, T. (1990) Design considerations for AIDS trials. (Abstract). The New England Journal of Medicine, 323, 1343-1348.
8. 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. & the Medical Research Council Adult Leukaemia Working Party (2003) High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. The New England Journal of Medicine, 348, 1875-1883.
9. Cox, D.R. (1972) Regression models and life-tables (with discussion). Journal of the Royal statistical Society, B, 34, 187-220.
10. Durie, B.G.M. & Salmon, S.E. (1975) A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival. Cancer, 36, 824-854.
11. Facon, T., Mary, J.Y., Pegourie, B., Attal, M., Renaud, M., Sadoun, A., Voillat, L., Dorvaux, V., Hulin, C., Lepeu, G., Harousseau, J.L., Eschard, J.P., Ferrant, A., Blanc, M., Maloisel, F., Orfeuvre, H., Rossi, J.F., Azais, I., Monconduit, M., Collet, P., Anglaret, B., Yakoub-Agha, I., Wetterwald, M., Eghbali, H., Vekemans, M.C., Maisonneuve, H., Troncy, J., Grosbois, B., Doyen, C., Thyss, A., Jaubert, J., Casassus, P., Thielemans, B., Bataille, R. & for the Intergroupe Francophone du Myelome (IFM) group (2006) Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy. Blood, 107, 1292-1298.
12. Girling, D., Parmar, M., Stennings, S., Stephens, R. & Stewart, L. (2003) Design Issues for Randomized Trials. Clinical Trials in Cancer Principles and Practice. Oxford University Press, Oxford.
13. Hernandez, J.M., Garcia-Sanz, R., Golvano, E., Blade, J., Fernandez-Calvo, J., Trujillo, J., Soler, J.A., Gardella, S., Carbonell, F., Mateo, G. & San Miguel, J.F. (2004) Randomized comparison of dexamethasone combined with melphalan versus melphalan with prednisone in the treatment of elderly patients with multiple myeloma. British Journal of Haematology, 127, 159-164.
14. Imrie, K., Esmail, R., Meyer, R.M. & and the Members of the Hematology Disease Site Group of the Cancer Care Ontario Practice Guidelines Initiative (2002) The role of high-dose chemotherapy and stem-cell transplantation in patients with multiple myeloma: a Practice Guideline of the Cancer Care Ontario Practice Guidelines Initiative. Annals of Internal Medicine, 136, 619-629.
15. Kaplan, E.L. & Meier, P. (1958) Nonparametric estimation from incomplete observations. J Am Stat Assoc, 53, 457-481.
16. Mantel, N. (1966) Evaluation of survival data and two rank order statistics arising in its consideration. Cancer Chemotherapy Reports, 50, 163-170.
17. 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. Myeloma Trialists' Collaborative Group. Journal of Clinical Oncology, 16, 3832-3842.
18. Myeloma Trialists' Collaborative Group (2001) Interferon as therapy for multiple myeloma: an individual patient data overview of 24 randomized trials and 4012 patients. British Journal of Haematology, 113, 1020-1034.
19. Palumbo, A., Bringhen, S., Caravita, T., Merla, E., Capparella, V., Callea, V., Cangialosi, C., Grasso, M., Rossini, F. & Galli, M. (2006) Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. The Lancet, 367, 825-831.
20. Pater, J. & Crowley, J. (2006) Sequential randomization. In: Handbook of Statistics in Clinical Oncology (ed. by J. Crowley & D. Ankerst), pp. 589-596. Chapman and Hall / CRC, Boca Raton, London, New York.
21. Pocock, S.J. & Simon, R. (1975) Sequential treatment assignment with balancing for prognostic factors in the controlled clinical trial. Biometrics, 31, 103-115.
22. Salmon, S.E., Crowley, J.J., Grogan, T.M., Finley, P., Pugh, R.P. & Barlogie, B. (1994) Combination chemotherapy, glucocorticoids, and interferon alfa in the treatment of multiple myeloma: a Southwest Oncology Group study. Journal of Clinical Oncology, 12, 2405-2414.
23. Shustik, C., Johnston, D., James, K., Zee, B., Meyer, R., Belch, A., Klasa, R., Meharchand, J. & Pater, J. (1997) Glucocorticoid dose-related susceptibility to infection in myeloma patients treated with melphalan. (Abstract). Blood, 90, 358a. Abst. # 1596.
24. Shustik, C., Belch, A., Meyer, R., Robinson, S., Rubin, S., Barr, R., Kovacs, M., Wilson, J., Shepherd, L., Djurfeldt, M. & Zee, B. (2001) Melphalan-dexamethasone is not superior to melphalan-prednisone as induction therapy in multiple myeloma. (Abstract). Proceedings of the American Society of Clinical Oncology, 20, 298a. Abst. # 1191.