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Phase II Clinical and Pharmacokinetic Study of Plitidepsin 3-Hour Infusion Every Two Weeks Alone or with Dexamethasone in Relapsed and Refractory Multiple Myeloma
Authors: Mateos, M.V. (María Victoria)
Cibeira, M. (M.T.)
Richardson, P.G. (Paul G.)
Prosper, F. (Felipe)
Oriol, A. (Albert)
Rubia, J. (J.) de la
Lahuerta, J.J. (Juan J.)
Garcia-Sanz, R. (R.)
Extremera, S. (S.)
Szyldergemajn, S. (Sergio)
Corrado, C. (C.)
Singer, H. (H.)
Mitsiades, C.S. (Constantine S.)
Anderson, K.C. (K.C.)
Blade, J. (J.)
San-Miguel, J.F. (Jesús F.)
Keywords: Materias Investigacion::Ciencias de la Salud::Oncología
Issue Date: 2010
Publisher: American Association for Cancer Research
Publisher version:
ISSN: 1078-0432
Citation: Mateos, M. V., Cibeira, M. T., Richardson, P. G., Prosper, F. et al.Phase II Clinical and Pharmacokinetic Study of Plitidepsin 3-Hour Infusion Every Two Weeks Alone or with Dexamethasone in Relapsed and Refractory Multiple Myeloma.Clin Cancer Res (2010); 16 (12): 3260-3269
Purpose: This trial evaluated the antitumor activity and safety of the marine-derived cyclodepsipeptide plitidepsin in patients with relapsed/refractory multiple myeloma. Experimental Design: This was a prospective, multicenter, open-label, single-arm, phase II trial with plitidepsin at 5 mg/m2 as a 3-hour i.v. infusion every two weeks. The protocol was amended to allow patients with suboptimal response to single-agent plitidepsin to add 20 mg/day on days 1 to 4 of oral dexamethasone every two weeks. Results: Fifty-one patients started treatment with plitidepsin and 47 were evaluable for efficacy. The overall response rate (complete response plus partial response plus minimal response) was 13% with plitidepsin alone and 22% in the cohort of patients with the addition of dexamethasone (n = 19, 18 evaluable). Both plitidepsin alone and with dexamethasone were feasible and well tolerated. Anemia (29%) and thrombocytopenia (18%) were the most frequent grade 3/4 hematologic toxicities. Fatigue (16%), muscular toxicity (6%), and transient alanine aminotransferase/aspartate aminotransferase (27%) and creatine phosphokinase (23%) increases were the most relevant nonhematologic side effects. A prolonged plasma half-life was observed in responding patients as compared with nonresponding patients (P = 0.009). Conclusions: Single-agent plitidepsin has limited but reproducible activity in relapsed/refractory multiple myeloma patients. Activity observed after dexamethasone addition merits further study. Both regimens were well tolerated in this heavily pretreated population.
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Appears in Collections:DA - CIMA - Oncología - Síndromes mieloproliferativos - Artículos de Revista
DA - CIMA - Oncología - Terapia celular - Artículos de Revista
DA - CUN - Área de Terapia Celular - Artículos de revista
DA - Medicina - Hematología - Artículos de revista

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