Spots Global Cancer Trial Database for Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia
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Trial Identification
Brief Title: Lenalidomide and Dexamethasone in Primary Plasma Cell Leukemia
Official Title: A Pilot Study of Lenalidomide and Dexamethasone in Patients With Primary Plasma Cell Leukemia
Study ID: NCT01553357
Conditions
Interventions
Study Description
Brief Summary: This is an open label, multicenter, exploratory, single arm, two-stage study aiming to explore efficacy and safety of lenalidomide and dexamethasone combination (LD) as first line therapy in previously untreated patients with primary Plasma Cell leukemia (PPCL).
Detailed Description: The primary endpoint was response rate according to International Uniform Criteria; secondary endpoints were: i) time to progression (TTP), progression free survival (PFS, and overall survival (OS); ii) percentage of eligible PPCL patients able to mobilize and collect peripheral blood stem cells after LD treatment; iii) percentage of eligible PPCL patients able to undergo autologous or allogeneic stem cells transplantation after LD treatment; iv) serious/severe adverse event (SAEs) rate.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
IRCCS - CROB Ethic Committee, Rionero in Vulture, Pz, Italy
Contact Details
Name: Pellegrino Musto, MD
Affiliation: GIMEMA Multiple Myeloma Working Party
Role: PRINCIPAL_INVESTIGATOR
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