Clinical trial NCT00911105: Non -Interventional Study-Palliative Therapy of Multiple Myeloma With a Combination of Lenalidomide and Dexamethasone
Official title: Combined Application of Lenalidomide and Desamethasone in the Palliative Therapy of Patients With Multiple Myeloma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Non-interventional study
Lenalidomide
Dexamethasone
Observational
Time to progression
Clinical routine
Germany
Plasmacytoma
Lead sponsor: iOMEDICO AG
Sponsor class: INDUSTRY
First posted: 2009-06-01
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with mutiple myeloma receiving a combination therapy with Lenalidomide and Dexamethasone.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Time to progression (TTP)
timeFrame: maximum 3 years per Patient
Secondary outcomes:
measure: Overall Response Rate
timeFrame: maximum 3 years per Patient
measure: Time to Treatment Discontinuation (TTD)
timeFrame: maximum 3 years per Patient
measure: Overall Survival (OS)
timeFrame: maximum 3 years per Patient
measure: Safety Profile
timeFrame: maximum 3 years per Patient
measure: Dosage of Lenalidomide and Dexamethasone
timeFrame: maximum 3 years per Patient
measure: Kidney Function
timeFrame: maximum 3 years per Patient
measure: Neutropenia / Infection (Concomitant Medication)
timeFrame: maximum 3 years per Patient
measure: Thrombosis Prophylaxis
timeFrame: maximum 3 years per Patient
Other outcomes:
Locations:
city: Bad Homburg
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Berlin
country: Germany
facility: Onkologische Schwerpunktpraxis
city: Berlin
country: Germany
facility: Onkologisches Versorgungszentrum Friedrichshain
city: Berlin
country: Germany
facility: Onkologische Praxis
city: Frankfurt am Main
country: Germany
facility: Onkologische Gemeinschaftspraxis
city: Germering
country: Germany
facility: Praxis für Innere Medizin
city: Groitzsch
country: Germany
facility: MedResearch - Medizinisches Studien- und Dokumentationszentrum Leipziger Land
city: Guestrow
country: Germany
facility: Internistische Gemeinschaftspraxis
city: Hamburg
country: Germany
facility: Praxis für Innere Medizin, Haematologie und Internistische Onkologie
city: Heidenheim
country: Germany
facility: Tumorpraxis Heidenheim
city: Krefeld
country: Germany
facility: Onkol. Gem.praxis Dr. M. Neise & Dr. A. Lollert
city: Lebach
country: Germany
facility: Onkologisches Zentrum Lebach
city: Lehrte
country: Germany
facility: Onkologische Gemeinschaftspraxis
city: Leipzig
country: Germany
facility: Gemeinschaftspraxis Dr. Aldaoud - Dr. Schwarzer
city: Muehlheim
country: Germany
facility: Praxis für Haematologie und Onkologie
city: Neumarkt I. D. O.
country: Germany
facility: Praxis fuer Innere Medizin
city: Neuss
country: Germany
facility: Praxis fuer Onkologie und Haematologie
city: Nordhorn
country: Germany
facility: Haematologisch-Onkologische Gemeinschaftspraxis
city: Oldenburg
country: Germany
facility: Onkologische Praxis Oldenburg
city: Wuerselen
country: Germany
facility: Onkologische Gemeinschaftspraxis
Study officials:
References: