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Brief Title: Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma
Official Title: Phase I Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma
Study ID: NCT02100657
Brief Summary: Study of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in Combination with Bortezomib and Dexamethasone in Patients with Relapsed and/or Refractory Multiple Myeloma.
Detailed Description: Phase I Multicenter, Open-label, Dose-escalating Clinical and Pharmacokinetic Trial of Plitidepsin (Aplidin®) to determine the recommended dose (RD) of plitidepsin in combination with bortezomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM), to determine the efficacy of the combination plitidepsin/bortezomib/dexamethasone, to evaluate the safety and tolerability of the combination in patients with relapsing and/or refractory MM and to study the pharmacokinetics (PK) and pharmacodynamics (PDy) of plitidepsin in combination with bortezomib and dexamethasone.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Institut Gustave Roussy, Villejuif, , France
Hospital Universitario Germans Trias I Pujol, Badalona, Barcelona, Spain
Clínica Universidad de Navarra, Pamplona, Navarra, Spain
MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital Universitario Salamanca, Salamanca, , Spain
Hospital Universitario Virgen del Rocío, Sevilla, , Spain
Hospital Universitari i Politècnic la Fe, Valencia, , Spain