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

NCT02608515 | Completed

• 1 other identifier: NIPMS-GENESIS-MM-GRC-002
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• Evaluation of the 12-month PFS rate in patients treated with Len/Dex at 1st relapse

  PFS rate

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genesis Pharma S.A.: lead

Study Sites (1)

Patra

Pátrai, 26443, Greece

Location

Related Links

• Published Manuscript

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Kiki Karvounis

  Medical Department of Genesis Pharma SA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 18, 2015
• Study Start: December 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 22, 2018

Record last verified: 2018-05

Locations

GR (1)