Overview

This trial is active, not recruiting.

Condition multiple myeloma
Sponsor iOMEDICO AG
Start date May 2009
End date April 2012
Trial size 100 participants
Trial identifier NCT00911105, IOM-0810

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Patients with multiple myeloma receiving second line therapy or higher.

Primary Outcomes

Measure
Time to progression (TTP)
time frame: maximum 3 years per Patient

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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)

Additional Information

Official title Combined Application of Lenalidomide and Desamethasone in the Palliative Therapy of Patients With Multiple Myeloma
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by iOMEDICO AG.