Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial

Lancet

Volumn 370, Issue 9594, 2007, Pages 1209-1218

  Facon, Thierry ^a   Mary, Jean Yves ^b   Hulin, Cyrille ^c   Benboubker, Lotfi ^d   Attal, Michel ^e   Pegourie, Brigitte ^f   Renaud, Marc ^g   Harousseau, Jean Luc ^h   Guillerm, Gaëlle ⁱ   Chaleteix, Carine ^j   Dib, Mamoun ^k   Voillat, Laurent ^l   Maisonneuve, Hervé ^m   Troncy, Jacques ⁿ   Dorvaux, Véronique ^m   Monconduit, Mathieu ^o   Martin, Claude ^p   Casassus, Philippe ^q   Jaubert, Jérôme ^r   Jardel, Henry ^s   Doyen, Chantal ^t   Kolb, Brigitte ^u   Anglaret, Bruno ^v   Grosbois, Bernard ^w   Yakoub Agha, Ibrahim ^a   Mathiot, Claire ^x   Avet Loiseau, Hervé ^h   more..

^a LILLE UNIVERSITY HOSPITAL   (France)

^b INSERM   (France)

^c UNIVERSITY HOSPITAL OF NANCY   (France)

^d UNIVERSITY HOSPITAL OF TOURS   (France)

^e TOULOUSE UNIVERSITY HOSPITAL   (France)

^f GRENOBLE UNIVERSITY HOSPITAL   (France)

^g POITIERS UNIVERSITY HOSPITAL   (France)

^h NANTES UNIVERSITY HOSPITAL   (France)

ⁱ BREST UNIVERSITY HOSPITAL   (France)

^j UNIVERSITY HOSPITAL OF CLERMONT FERRAND   (France)

^k ANGERS UNIVERSITY HOSPITAL   (France)

^l UNIVERSITY HOSPITAL OF BESANÇON   (France)

^m Service d'Hématologie   (France)

ⁿ EDOUARD HERRIOT HOSPITAL   (France)

^o CENTRE HENRI BECQUEREL   (France)

^p CH   (France)

^q Department of Otolaryngology Head and Neck Surgery   (France)

^r UNIVERSITY HOSPITAL OF SAINT ETIENNE   (France)

^s Service d Hématologie   (France)

^t UNIVERSITÉ CATHOLIQUE DE LOUVAIN   (Belgium)

^u REIMS UNIVERSITY HOSPITAL   (France)

^v Service d hématologie   (France)

^w RENNES UNIVERSITY HOSPITAL   (France)

^x INSTITUT CURIE   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

CLODRONIC ACID; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOXORUBICIN; LYTOS; MELPHALAN; MESNA; PREDNISONE; PREDNISONE ACETATE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; THALIDOMIDE; UNCLASSIFIED DRUG; VINCRISTINE;

AGED; ANEMIA; ANGINA PECTORIS; ARTICLE; AUTOLOGOUS STEM CELL TRANSPLANTATION; BLEEDING; BLOOD TOXICITY; CANCER COMBINATION CHEMOTHERAPY; CARDIOTOXICITY; CLINICAL TRIAL; CONSTIPATION; CONTROLLED CLINICAL TRIAL; DIZZINESS; DRUG EFFICACY; DRUG SAFETY; EMBOLISM; FATIGUE; FEMALE; FOLLOW UP; GASTROINTESTINAL TOXICITY; HEART ARRHYTHMIA; HEART FAILURE; HEART INFARCTION; HERPES ZOSTER; HUMAN; HYPERTENSION; HYPOTENSION; INFECTION; MAJOR CLINICAL STUDY; MALE; MENINGITIS; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; NAUSEA; NEUTROPENIA; OVERALL SURVIVAL; PERIPHERAL NEUROPATHY; PNEUMONIA; PRIORITY JOURNAL; PYREXIA IDIOPATHICA; RANDOMIZED CONTROLLED TRIAL; REDUCED INTENSITY CONDITIONING; SEPTICEMIA; SOMNOLENCE; STATISTICAL ANALYSIS; THROMBOCYTOPENIA; THROMBOSIS;

EID: 34848833957     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(07)61537-2     Document Type: Article

References (25)

1. Alexanian R., Haut A., Khan A., et al. Treatment for multiple myeloma. Combination chemotherapy with different melphalan dose regimens. JAMA 208 (1969) 1680-1685
2. Bataille R., and Harousseau J. Multiple myeloma. N Engl J Med 336 (1997) 1657-1664
3. Myeloma Trialists' Collaborative Group. Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6 633 patients from 27 randomized trials. J Clin Oncol 16 (1998) 3832-3842
4. Facon T., Mary J., Pegourie B., et al. Dexamethasone-based regimens versus melphalan-prednisone for elderly multiple myeloma patients ineligible for high-dose therapy. Blood 107 (2006) 1292-1298
5. Singhal S., Mehta J., Desikan R., et al. Antitumor activity of thalidomide in refractory multiple myeloma. N Engl J Med 341 (1999) 1565-1571
6. Barlogie B., Tricot G., Anaissie E., et al. Thalidomide and hematopoietic-cell transplantation for multiple myeloma. N Engl J Med 354 (2006) 1021-1030
7. Palumbo A., Bringhen S., Caravita T., et al. Oral melphalan and prednisone chemotherapy plus thalidomide compared with melphalan and prednisone alone in elderly patients with multiple myeloma: randomised controlled trial. Lancet 367 (2006) 825-831
8. Rajkumar S., Blood E., Vesole D., Fonseca R., and Greipp P. Phase III clinical trial of thalidomide plus dexamethasone compared with dexamethasone alone in newly diagnosed multiple myeloma: a clinical trial coordinated by the Eastern Cooperative Oncology Group. J Clin Oncol 24 (2006) 431-436
9. Attal M., Harousseau J., Facon T., et al. Single versus double autologous stem-cell transplantation for multiple myeloma. N Engl J Med 349 (2003) 2495-2502
10. Child J., Morgan G., Davies F., et al. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med 348 (2003) 1875-1883
11. Attal M., Harousseau J., Leyvraz S., et al. Maintenance therapy with thalidomide improves survival in patients with multiple myeloma. Blood 108 (2006) 3289-3294
12. Palumbo A., Triolo S., Argentino C., et al. Dose-intensive melphalan with stem cell support (MEL100) is superior to standard treatment in elderly myeloma patients. Blood 94 (1999) 1248-1253
13. Palumbo A., Bringhen S., Petrucci M., et al. Intermediate-dose melphalan improves survival of myeloma patients aged 50 to 70: results of a randomized controlled trial. Blood 104 (2004) 3052-3057
14. Durie B., and Salmon S. A clinical staging system for multiple myeloma. Correlation of measured myeloma cell mass with presenting clinical features, response to treatment, and survival. Cancer 36 (1975) 842-854
15. Facon T., Avet-Loiseau H., Guillerm G., et al. Chromosome 13 abnormalities identified by FISH analysis and serum beta2-microglobulin produce a powerful myeloma staging system for patients receiving high-dose therapy. Blood 97 (2001) 1566-1571
16. Peto R., Pike M., Armitage P., et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. I. Introduction and design. Br J Cancer 34 (1976) 585-612
17. Kaplan E., and Meier P. Nonparametric estimation for incomplete observations. J Am Stat Assoc 53 (1958) 457-481
18. Cox D. Regression models and life-tables (with discussions), series B. J R Stat Soc 34 (1972) 184-192
19. Cox D., and Oakes D. Analysis of survival data (1984), Chapman & Hall, London
20. Peto R., Pike M., Armitage P., et al. Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. analysis and examples. Br J Cancer 35 (1977) 1-39
21. Byar D. Identification of prognostic factors. In: Buyse M., Staquet M., and Sylvester R. (Eds). Cancer clinical trials, methods and practice (1988), Oxford medical publications, Oxford 423-443
22. Hulin C., Virion J., Leleu X., et al. Comparison of melphalan-prednisone-thalidomide (MP-T) to melphalan-prednisone (MP) in patients 75 years of age or older with untreated multiple myeloma (MM). Preliminary results of the randomized, double-blind, placebo controlled IFM 01-01 trial (Intergroupe Francophone du Myelome)(abstract 8001). J Clin Oncol 25 (2007) 441s (N°18S)
23. Greipp P., Miguel J.S., Durie B., et al. International staging system for multiple myeloma. J Clin Oncol 23 (2005) 3412-3420
24. Mateos M., Hernandez J., Hernandez M., et al. Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: results of a multicenter phase 1/2 study. Blood 108 (2006) 2165-2172
25. 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 (2007). published online Sept 4. DOI: 10.1200/JCO.2007.12.3463