Phase II pethema trial of alternating bortezomib and dexamethasone as induction regimen before autologous stem-cell transplantation in younger patients with multiple myeloma: Efficacy and clinical implications of tumor response kinetics

Journal of Clinical Oncology

Volumn 25, Issue 28, 2007, Pages 4452-4458

  Rosiñol, Laura ^a   Oriol, Albert ^a   Mateos, Maria Victoria ^a   Sureda, Anna ^a   García Sánchez, Pedro ^a   Gutiérrez, Norma ^a   Alegre, Adrián ^a   Lahuerta, Juan José ^a   De La Rubia, Javier ^a   Herrero, Carlos ^a   Liu, Xiangyang ^a   Van De Velde, Helgi ^a   San Miguel, Jesús ^a   Bladé, Joan ^a  

^a HOSPITAL CLÍNIC   (Spain)

Author keywords

[No Author keywords available]

Indexed keywords

BORTEZOMIB; DEXAMETHASONE; M PROTEIN; ANTINEOPLASTIC AGENT; BORONIC ACID DERIVATIVE; PYRAZINE DERIVATIVE;

ADULT; AGED; ANALYTIC METHOD; ARTICLE; AUTOLOGOUS STEM CELL TRANSPLANTATION; CANCER DIAGNOSIS; CANCER PATIENT; CHROMOSOME DELETION; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED STUDY; DEPRESSION; DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG SAFETY; EPIDEMIC MENINGITIS; FATIGUE; FEMALE; GASTROINTESTINAL TOXICITY; HUMAN; LIVER TOXICITY; MACULOPAPULAR RASH; MALE; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; MYOPATHY; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; SKIN TOXICITY; THROMBOCYTOPENIA; AUTOTRANSPLANTATION; DRUG ADMINISTRATION; DRUG TOXICITY; MIDDLE AGED; MULTICENTER STUDY; REMISSION; STATISTICAL MODEL; STEM CELL TRANSPLANTATION;

ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BORONIC ACIDS; DEXAMETHASONE; DRUG ADMINISTRATION SCHEDULE; DRUG TOXICITY; FEMALE; HUMANS; LINEAR MODELS; MALE; MIDDLE AGED; MULTIPLE MYELOMA; PYRAZINES; REMISSION INDUCTION; STEM CELL TRANSPLANTATION; TRANSPLANTATION, AUTOLOGOUS;

EID: 35348898377     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/JCO.2007.12.3323     Document Type: Article

References (39)

1. Attal M, Harousseau J-L, Stoppa A-M, et al: A prospective, randomized trial of autologous bone marrow transplantation and chemotherapy in multiple myeloma. N Engl J Med 335:91-97, 1996
2. Barlogie B, Jagannath S, Desikan KR, et al: Total therapy with tandem transplants for newly diagnosed multiple myeloma. Blood 93:55-56, 1999
3. Child JA, Morgan GJ, Davies FE, et al: Highdose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med 348:1875-1883, 2003
4. Fermand JP, Katsahian S, Divine M, et al: High-dose therapy and autologous blood stem-cell transplantation compared with conventional treatment in myeloma patients aged 55 to 65 years: Long-term results of a randomized control trial from the Group Myelome-Autogreffe. J Clin Oncol 23:9227-9233, 2005
5. Blade J, Rosiñol L, Sureda A, et al: High-dose therapyintensificationversuscontinuedstandardchemotherapy in multiple myeloma: Long-term results from a prospective randomized trial from the Spanish Group PETHEMA. Blood 106:3755-3759, 2005
6. Alexanian R, Weber D, Giralt S, et al: Impact of complete remission with intensive therapy in patients with responsive multiple myeloma. Bone Marrow Transplant 27:1037-1043, 2001
7. Nadal E, Gine E, Bladé J, et al: High-dose therapy/autologous stem cell transplantation in patients with chemosensitive multiple myeloma: Predictors of complete remission. Bone Marrow Transplant 33:61-64, 2004
8. Moreau P, Garban F, Harousseau JL, et al: The prognostic impact of complete remission (CR) plus very good partial remission (VGPR) in a double-transplantation program for newly diagnosed multiple myeloma (MM): Combined results of the IFM 99 trials. Blood 108:877, 2006 (suppl, abstr 3077)
9. Richardson PG, Barlogie B, Berenson J, et al: A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med 348:2609-2617, 2003
10. Jagannath S, Barlogie B, Berenson J, et al: A phase 2 study of two doses of bortezomib in relapsed or refractory myeloma. Br J Haematol 127:165-172, 2004
11. 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
12. Richardson P, Sonneveld P, Schuster M, et al: Bortezomib continues demonstrates superior efficacy compared with high dose dexamethasone in relapsed multiple myeloma: Updated results of the APEX trial. Blood 106:715, 2005 (suppl, abstr 2547)
13. 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
14. Richardson P, Chanan-Khan A, Schlossman R, et al: A multicenter phase II trial of bortezomib in patients with previously untreated multiple myeloma: Efficacy with manageable toxicity in patients with unexpectedly high rates of baseline peripheral neuropathy. Blood 106:716, 2005 (suppl, abstr 2548)
15. Anderson K, Richardson PG, Chanan-Khan A, et al: Single-agent bortezomib in previously untreated multiple myeloma (MM): Results of a phase II multicenter study. J Clin Oncol 24:423s, 2006 (suppl 18S; abstr 7504)
16. Jagannath S, Durie BG, Wolf J, et al: Bortezomib therapy alone and in combination with dexamethasone for previously untreated symptomatic multiple myeloma. Br J Haematol 129:776-783, 2005
17. 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
18. Harousseau JL, Attal M, Leleu X, et al: Bortezomib plus dexamethasone as induction treatment prior to autologous stem cell transplantation in patients with newly diagnosed multiple myeloma: Results of an IFM phase II study. Haematologica 91:1498-1505, 2006
19. 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
20. San Miguel J, Bladé J, Boccadoro M, et al: A practical update on the use of bortezomib in the management of multiple myeloma. Oncologist 11:51-61, 2006
21. 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 hematopoietic stem cell transplantation. Br J Haematol 102:1115-1123, 1998
22. Durie BGM, Harousseau JL, San Miguel J, et al: International uniform response criteria for multiple myeloma. Leukemia 20:1467-1473, 2006
23. Goldstein H: Multilevel Statistical Models. London, United Kingdom, Arnold, 1995
24. Cavo M, Zamagni E, Tosi P, et al: Superiority of thalidomide and dexamethasone over vincristine-doxorubicin-dexamethasone (VAD) as primary therapy in preparation for autologous transplantation for multiple myeloma. Blood 106:35-39, 2005
25. Rajkumar SV, Blood E, Vesole D, et al: 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 24:431-436, 2006
26. Rajkumar SV, Hussein M, Catalano J, et al: A randomized, double-blind, placebo-controlled trial of thalidomide plus dexamethasone versus dexamethasone alone as primary therapy for newly diagnosed multiple myeloma. Blood 108:238, 2006 (suppl, abstr 795)
27. Macro M, Divine M, Uzunhan Y, et al: Dexamethasone + thalidomide (Dex/Thal) compared to VAD as a pretransplant treatment in newly diagnosed multiple myeloma (MM): A randomized trial. Blood 108:22, 2006 (abstr 57)
28. Thomas SK, Giralt SA, Wang M, et al: Survival outcomes of patients receiving thalidomidedexamethasone for previously untreated multiple myeloma. Blood 108:1019, 2006 (suppl, abstr 3569)
29. Rajkumar SV, Hayman SR, Lacy MQ, et al: Combination therapy with lenalidomide plus dexamethasone (Rev/Dex) for newly diagnosed myeloma. Blood 106:4050-4053, 2005
30. Alexanian R, Dimopoulos MA, Delasalle K, et al: Primary dexamethasone treatment of multiple myeloma. Blood 80:887-890, 1992
31. Facon T, Mary JY, Pégourie B, et al: Dexamethasone-based regimens versus melphalanprednisone for elderly multiple myeloma patients ineligible for high-dose therapy. Blood 107:1292-1298, 2006
32. Wang M, Delasalle K, Giralt S, et al: Rapid control of previously untreated multiple myeloma with bortezomib-thalidomide-dexamethasone followed by early intensive therapy. Blood 106:231, 2005 (suppl, abstr 784)
33. Mateos MV, Hernández JM, Hernández MT, et al: Bortezomib plus melphalan and prednisone in elderly untreated patients with multiple myeloma: Results of a multicenter phase I/II study. Blood 108:2165-2172, 2006
34. Jagannath S, Richardson PG, Sonneveld P, et al: Bortezomib appears to overcome the poor prognosis conferred by chromosome 13 deletion in phase 2 and 3 trials. Leukemia 21:151-157, 2007
35. Sagester V, Ludwig H, Kaufmann H, et al: Bortezomib in relapsed multiple myeloma: Response rates and duration of response are independent of a chromosome 13q-deletion. Leukemia 21:164-168, 2007
36. Harousseau JL, Marit G, Caillot D, et al: Velcade/dexamethasone (Vel/Dex) versus VAD as induction treatment prior to autologous stem cell transplantation (ASCT) in newly diagnosed multiple myeloma (MM): An interim analysis of the IFM 2005-01 randomized multicenter phase III trial. Blood 108:882, 2006 (suppl, abstr 56)
37. Jakubowiak AJ, A-Zoubi A, Kendall T, et al: High rate of complete and near complete responses (CR/nCR) after initial therapy with bortezomib (Velcade), Doxil, and dexamethasone (VDD) is further increased after autologous stem cell transplantation (ASCT). Blood 108:21, 2006 (suppl, abstr 3093)
38. Oakervee HE, Popat R, Curry N, et al: PAD combination therapy (PS-341/bortezomib, doxorubicin and dexamethasone) for previously untreated patients with multiple myeloma. Br J Haematol 129:755-762, 2005
39. Popat R, Oakervee HE, Curry N, et al: Reduced dose PAD combination therapy (PS 341/bortezomib, Adriamycin and dexamethasone) for previously untreated patients with multiple myeloma. Blood 106:717, 2005 (suppl; abstr 2554)