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Brief Title: Lenalidomide & Adriamycin & Dexamethasone (RAD) in Newly Diagnosed, Multiple Myeloma Patients
Official Title: Phase II Open Label Study for the Assessment of the Efficacy and Safety of Lenalidomide & Adriamycin & Low Dose Dexamethasone (RAD) in Newly Diagnosed, Symptomatic Multiple Myeloma Patients
Study ID: NCT02471820
Brief Summary: This study is to assess the efficacy and safety of lenalidomide in combination with adriamycin and low dose dexamethasone in newly diagnosed patients with symptomatic multiple myeloma as well as to collect information regarding the effect of this regimen on angiogenesis and bone remodeling of the study population.
Detailed Description: This is a Phase II, non randomized, non- comparative, open label trial which assess the efficacy and safety of lenalidomide, adriamycin and low dose dexamethasone combination (RAD) in 45 newly diagnosed patients with symptomatic multiple myeloma as well as to collect information regarding the effect of this regimen on angiogenesis and bone remodeling of the study population. The recruitment period is estimated for 5 months while the treatment period and the follow up period 4 months and 1 month respectively. During the treatment initiation visit the response to the combination RAD according the International Myeloma Working Group (IMWG) criteria will be evaluated, biochemical markers of bone metabolism and angiogenic cytokines will be measured as well. IMWG Response evaluation will be repeated the day 1 of each treatment cycle as well as at the response evaluation visit. Finally biochemical markers of bone metabolism and angiogenic cytokines will be measured once more at the end of treatment visit.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
General Hospital of Athens "G. Gennimatas", Athens, Attica, Greece
General Hospital of Athens "Alexandra", Athens, Attica, Greece
University General Hospital of Patras, Patra, , Greece
Theageneio Anticancer Hospital of Thessaloniki, Thessaloniki, , Greece
Name: Meletios Dimopoulos, Doctor
Affiliation: General Hospital of Athens "Alexandra"
Role: PRINCIPAL_INVESTIGATOR
Name: Eirini Katodritou, Doctor
Affiliation: Theageneio Anticancer Hospital of Thessaloniki
Role: PRINCIPAL_INVESTIGATOR
Name: Nikolaos Anagnostopoulos, Doctor
Affiliation: General Hospital of Athens "G. Gennimatas''
Role: PRINCIPAL_INVESTIGATOR
Name: Argirios Symeonidis, Doctor
Affiliation: University General Hospital of Patras
Role: PRINCIPAL_INVESTIGATOR