Non -Interventional Study-Palliative Therapy of Multiple Myeloma With a Combination of Lenalidomide and Dexamethasone

Completed

• Conditions: Multiple Myeloma

• Registration Number: NCT00911105
• Lead Sponsor: iOMEDICO AG

Brief Summary

Purpose of this non-interventional study is the documentation of efficacy and safety data of multiple myeloma therapy with a combined treatment of Lenalidomide and Dexamethasone in daily routine practice.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-28
• Study First Submitted QC: 2009-05-28
• Study First Posted: 2009-06-01
• Primary Completion: 2012-04
• Study Completion: 2015-11
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-04
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• Patients with multiple myeloma with at least one previous therapy.
• 18 years or older
• Signed, written informed consent

Exclusion Criteria

• Pregnancy or nursing
• All other exclusion criteria listed in SmPC (summary of product characteristics)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to progression (TTP)	maximum 3 years per Patient

Secondary Outcome Measures

Name	Time	Method
Kidney Function	maximum 3 years per Patient
Thrombosis Prophylaxis	maximum 3 years per Patient
Overall Response Rate	maximum 3 years per Patient
Time to Treatment Discontinuation (TTD)	maximum 3 years per Patient
Overall Survival (OS)	maximum 3 years per Patient
Safety Profile	maximum 3 years per Patient
Dosage of Lenalidomide and Dexamethasone	maximum 3 years per Patient
Neutropenia / Infection (Concomitant Medication)	maximum 3 years per Patient

Trial Locations

Locations (17)

Praxis für Innere Medizin; 🇩🇪 Germering, Germany

Onkologische Gemeinschaftspraxis; 🇩🇪 Wuerselen, Germany

MedResearch - Medizinisches Studien- und Dokumentationszentrum Leipziger Land; 🇩🇪 Groitzsch, Germany

Internistische Gemeinschaftspraxis; 🇩🇪 Guestrow, Germany

Onkol. Gem.praxis Dr. M. Neise & Dr. A. Lollert; 🇩🇪 Krefeld, Germany

Praxis für Innere Medizin, Haematologie und Internistische Onkologie; 🇩🇪 Hamburg, Germany

Onkologisches Zentrum Lebach; 🇩🇪 Lebach, Germany

Gemeinschaftspraxis Dr. Aldaoud - Dr. Schwarzer; 🇩🇪 Leipzig, Germany

Onkologische Praxis Oldenburg; 🇩🇪 Oldenburg, Germany

Praxis fuer Innere Medizin; 🇩🇪 Neumarkt I. D. O., Germany

Praxis für Haematologie und Onkologie; 🇩🇪 Muehlheim, Germany

Tumorpraxis Heidenheim; 🇩🇪 Heidenheim, Germany

Praxis fuer Onkologie und Haematologie; 🇩🇪 Neuss, Germany

Haematologisch-Onkologische Gemeinschaftspraxis; 🇩🇪 Nordhorn, Germany

Onkologische Schwerpunktpraxis; 🇩🇪 Berlin, Germany

Onkologisches Versorgungszentrum Friedrichshain; 🇩🇪 Berlin, Germany

Onkologische Praxis; 🇩🇪 Berlin, Germany