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

Combined Application of Lenalidomide and Desamethasone in the Palliative Therapy of Patients With Multiple Myeloma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00911105

Acronym

REVLIMID-NIS

Enrollment

101

Registered

2009-06-01

Start date

2009-05-31

Completion date

2015-11-30

Last updated

2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma, Non-interventional study, Lenalidomide, Dexamethasone, Observational, Time to progression, Clinical routine, Germany, Plasmacytoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Overall Response Rate	maximum 3 years per Patient
Kidney Function	maximum 3 years per Patient
Neutropenia / Infection (Concomitant Medication)	maximum 3 years per Patient
Thrombosis Prophylaxis	maximum 3 years per Patient
Dosage of Lenalidomide and Dexamethasone	maximum 3 years per Patient

Countries

Germany

Outcome results