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

NCT ID: NCT02608515

Last Updated: 2018-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-09-30

Brief Summary

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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

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Conditions

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Relapsed/Refractory Multiple Myeloma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genesis Pharma S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kiki Karvounis

Role: STUDY_DIRECTOR

Medical Department of Genesis Pharma SA

Locations

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Patra

Pátrai, , Greece

Site Status

Countries

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Greece

Related Links

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Other Identifiers

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NIPMS-GENESIS-MM-GRC-002

Identifier Type: -

Identifier Source: org_study_id

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