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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02608515

Acronym

LEGEND

Enrollment

207

Registered

2015-11-18

Start date

2015-12-31

Completion date

2016-09-30

Last updated

2018-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Multiple Myeloma

Brief summary

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of the 12-month PFS rate in patients treated with Len/Dex at 1st relapse	12 months	PFS rate

Countries

Greece

Outcome results