An Observational Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide.

Study Overview
=================
Brief Summary
-----------------
The study is designed as a prospective, non-interventional, observational single arm study. Hundred-fifty patients over 18 with stable disease or at least partial response while on treatment with lenalidomide will be recruited from approximately 20 haematology/oncology sites in the Netherlands. Recruitment will continue until 150 patients have started the study. When this target is reached, all patients on lenalidomide will continue to be followed until the last patient has been followed for 36 months.

Official Title
-----------------
A Non-interventional Observational Post Authorization Study to Assess Safety and Outcome of the Various Medication Usage Patterns in Clinical Routine Practice in Patients Receiving Lenalidomide (REVIEW)

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years of age who understand and voluntarily sign an informed consent form. Patients with multiple myeloma who are currently receiving lenalidomide treatment and who have taken lenalidomide for > 2 cycles and < 6 cycles. Patients with currently stable disease or meeting the criteria for complete response, very good partial response or partial response while on lenalidomide treatment. Exclusion Criteria: Refusal to participate in the study. Women who are pregnant or breast-feeding. Women of childbearing potential unless all of the conditions of the Pregnancy Prevention Programme are met. Hypersensitivity to the active substance or to any of the excipients.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients receiving Revlimid according to clinical practice<br> | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event (AE) | Adverse events will be classified using the MedDRA classification system. The severity of the toxicities will be graded according to the NCI CTCAE VERSION 4.03 whenever possible | Up to approximatly 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of life will be measured by using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QL Q-C30) and EORTC QLQ-MY20 | Up to approximatly 24 months | 
| Lenalidomide usage patterns | Registration in case report form (CRF) and evaluation of usage patterns in daily clinical practice | Up to approximatly 4 years | 
| Lenalodomide dose modifications | Registration in case report form (CRF) and evaluation of dose modifications in daily clinical practice | Up to approximatly 4 years | 
| Reasons for discontinuation of lenalidomide | Registration in case report form (CRF) and evaluation of reasons of discontinuation in daily clinical practice | Up to approximatly 4 years | 
| Clinical outcome | Clinical outcome will be measured using routine assessment criteria (i.e. IMWG) | Up to approximately 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myeloma, Non-interventional, Observational, Lenalidomide, REVIEW, Post-authorization, Netherlands