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Spots Global Cancer Trial Database for Lenalidomide & Adriamycin & Dexamethasone (RAD) in Newly Diagnosed, Multiple Myeloma Patients

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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