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

Completed

• Conditions: Relapsed/Refractory Multiple Myeloma

• Registration Number: NCT02608515
• Lead Sponsor: Genesis Pharma S.A.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-17
• Study First Submitted QC: 2015-11-17
• Study First Posted: 2015-11-18
• Study Start: 2015-12
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-18
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 207

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Patra; 🇬🇷 Patra, Greece