The consensus that Revlimid is appropriate for first line therapy is reflected in a Phase III ECOG trial that investigates high versus low dose dexamethason with Revlinid in first line therapy. On 4/5, Celgene Corporation (Nasdaq: CELG) announced that the Eastern Cooperative Oncology Group (ECOG) has reported that its Data Monitoring Committee’s (DMC) review of preliminary results from a large, randomized clinical trial for patients with newly diagnosed multiple myeloma has found that the use of a low dose of dexamethasone (Decadron) in combination with lenalidomide suggests survival advantage for patients when compared to the higher, standard-dose of dexamethasone that is used in combination with lenalidomide to treat.
Bortezomib is a first-in-class proteasome inhibitor that has shown remarkable efficacy in multiple myeloma. Bortezomib has shown activity as first-line treatment in newly diagnosed, untreated multiple myeloma in two phase II studies.
Data from a Phase II trial suggest that the three drug combination (Rev-Vel-dex) is very effective. Overall, 73% of 33 evaluable patients responded to this treatment and 36% had significant reductions in M protein (a very good partial response, near complete response, or complete response). Patients tended to respond for a prolonged period of time, nearly 10 months. Phase III studies confirmed effectiveness and NCCN added this regimen to its guidelines .
P. Moreau, J. San Miguel, P. Sonneveld, M. V. Mateos, E. Zamagni, H. Avet-Loiseau, R. Hajek, M. A. Dimopoulos, H. Ludwig, H. Einsele, S. Zweegman, T. Facon, M. Cavo, E. Terpos, H. Goldschmidt, M. Attal & C. Buske, Multiple Myeloma: ESMO Clinical Practice Guidelines. Ann Oncol (2017) 28 (suppl 4): iv52–iv61.
Weber D, Chen C, Niesvizky R, et al. Lenalidomide Plus High-Dose Dexamethasone Provides Improved Overall Survival Compared to High-Dose Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma (MM): Results of a North American Phase III Study (MM-009). Proceedings from the 42nd annual meeting of the American Society of Clinical Oncology. Atlanta, Ga. June 2006. Abstract # 7521.
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