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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)

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ClinicalTrials.gov Identifier: NCT02608515
Recruitment Status : Completed
First Posted : November 18, 2015
Last Update Posted : May 22, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Relapsed/Refractory Multiple Myeloma

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Study Type : Observational
Actual Enrollment : 207 participants
Observational Model: Other
Time Perspective: Retrospective
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"
Study Start Date : December 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma




Primary Outcome Measures :
  1. Evaluation of the 12-month PFS rate in patients treated with Len/Dex at 1st relapse [ Time Frame: 12 months ]
    PFS rate



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
A total of approximately 220 patients with RRMM that started second-line treatment with lenalidomide/dexamethasone between 01 January 2009 to 01 March 2014 and who fulfill all study-specific eligibility criteria at the investigators' discretion will be included in this study
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608515


Locations
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Greece
Patra
Patra, Greece, 26443
Sponsors and Collaborators
Genesis Pharma S.A.
Investigators
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Study Director: Kiki Karvounis Medical Department of Genesis Pharma SA

Additional Information:
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Responsible Party: Genesis Pharma S.A.
ClinicalTrials.gov Identifier: NCT02608515    
Other Study ID Numbers: NIPMS-GENESIS-MM-GRC-002
First Posted: November 18, 2015    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Disease Progression
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Disease Attributes
Pathologic Processes