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

Relapsed/Refractory Multiple Myeloma Clinical Trial

— LEGEND  

Official 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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02608515
• Other study ID #: NIPMS-GENESIS-MM-GRC-002
• Status: Completed
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: May 2018
• Source: Genesis Pharma S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease Progression
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed/Refractory Multiple Myeloma

Locations

Country	Name	City	State
Greece	Patra	Patra

Sponsors (1)

Lead Sponsor	Collaborator
Genesis Pharma S.A.

Country where clinical trial is conducted

Greece, 

Outcome

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

External Links

•   Published Manuscript