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 (LEGEND)

Genesis Pharma

Status: Completed

Conditions: Relapsed/Refractory Multiple Myeloma

Study type: Observational

Funder types: Industry

Identifiers

NCT02608515

NIPMS-GENESIS-MM-GRC-002

Details and patient eligibility

About

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.

Enrollment: 207 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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