A Retrospective Chart Review Study of the Outcomes of 2nd Line Therapy With LEn/Dex in Greek Patients With R/R Multiple MyEloma and the Treatment PatterNs Following Progressive Disease

This non-interventional retrospective chart review study aims to evaluate the clinical outcomes of patients with RRMM receiving lenalidomide/dexamethasone (Len/Dex) treatment at 1st relapse and the treatment patterns following progressive disease as part of the routine clinical practice in Greece.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Relapsed/Refractory Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Patra

Pátrai, 26443, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects must fulfill ALL of the following criteria:

Subjects of both genders, aged 18 years or older
Subjects must have a relapsed or refractory MM diagnosis according to IMWG or EBMT criteria
Subjects must have initiated second-line therapy with lenalidomide/dexamethasone according to the approved products' Summary of Product Characteristics (SmPC) between 01 January 2009 and 01 March 2014
Subjects must have available medical files/records and detailed historical data on their disease course and clinical management
Provision of signed ICF for collecting and analyzing medical data pertinent to the objectives of this study

Exclusion criteria

For the candidate subjects NONE of the following criteria should apply:

Prior malignancy (within the 3 years preceding initial diagnosis of MM)
Concurrent administration of anti-cancer regimens for malignancies other than MM between the time of initial MM diagnosis and time of second relapse
Subject participation in an interventional study

Treatment and study plan

Primary outcomes

Evaluation of the 12-month PFS rate in patients treated with Len/Dex at 1st relapse

Time frame: 12 months

PFS rate

Sponsors and collaborators

Lead sponsor

Genesis Pharma S.A.

Industry

Registry information

Official study title

A Retrospective Chart Review Study of the Outcomes of Second Line Therapy With LEnalidomide/Dexamethasone in Greek Patients With Relapsed/Refractory Multiple MyEloma and the Treatment PatterNs Following Progressive Disease, "The LEGEND Study"

Acronym: LEGEND

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Nov 18, 2015
Registry last updated: May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed