A Non-interventional,Observational Post Authorization Study of Patients With Multiple Myeloma Treated With Lenalidomide TR
A Non-interventional,Observational Post Authorization Study of Patients With Multiple Myeloma Treated With Lenalidomide TR
CC-5013-PASS-TR/A non-interventional, multi-center, observational post authorization safety
 study of patients with relapsed/refractory multiple myeloma treated with Lenalidomide in
 Turkey.

 The study is anticipated to last for approximately 8 years. Recruitment period will continue
 until 500 subjects have commenced the third cycle of treatment with lenalidomide.
Objectives:

 - Primary: To characterize and determine the incidence of adverse events of special interest;
 in subjects treated with Lenalidomide in real life setting in given indication.

 - Secondary:

 1. To observe the basic adverse event management approaches of physicians

 2. To evaluate the effectiveness of Lenalidomide in given indication and to evaluate the
 prescription line.

 3. To monitor the reasons of patients' noncompliance with lenalidomide usage recommended in
 Patient Information Leaflet.

 Subjects will be recruited from approximately 36 hematology/oncology sites in Turkey. In all
 cases, the decision to treat the patient will be made prior to the decision to enter the
 subject into the study. All subjects enrolled will be prospectively followed up for up to 36
 months, where feasible, following the end of observed treatment period. This 36 month
 observation period will start from end of treatment. The observation follow up period will
 end 36 months after the end of lenalidomide or background observed treatment period, or at
 time of death, withdrawal of consent, or loss to follow up. Following completion of
 treatment, subjects will be followed up after 30 days and then every 6 months to assess
 status.

 Patients who are eligible and signed a consent form will be recruited consecutively. Subjects
 who temporarily discontinue treatment for any reason for more than 30 days will be withdrawn
 from treatment observation but will be observed for safety for up to 36 months (from the end
 of treatment). If the reason for discontinuation for subjects is due to an adverse event, the
 follow up of the adverse event will not be time limited and will continue until resolution or
 stabilization or when, in the opinion of the investigator, no additional useful information
 can be obtained from the event or the subject withdraws their consent to any more data being
 collected. Subjects will discontinue from the study if they switch to another treatment. No
 intervention will be performed to physician. Treatment will be according to physician's
 regular clinical practice.

 All treatments will be prescribed by the treating investigator in accordance with regular
 clinical practice.

 All assessments will be made according to the regular clinical practice of the treating
 investigator. Therefore if a parameter is requested on the case report form (CRF) but the
 investigator's normal practice is not to carry out such an assessment, then the field will
 not be completed.

 Statistical Analysis:

 Data from all subjects who receive at least one dose of treatment will be included in the
 safety analysis.

 Adverse events will be classified using the MedDRA classification system. The severity of the
 toxicities will be graded according to the NCI CTCAE V. 4.03 whenever possible.

 Adverse event frequency will be tabulated by body system and MedDRA term. In the by subject
 analysis, a subject having the same event more than once will be counted only once. Adverse
 events will be summarized by worst NCI CTCAE V. 4.03 grade.

 Adverse events leading to death or to discontinuation from treatment, study-drug-related
 events, and serious adverse events will be listed separately.

 The Kaplan-Meier procedures will be used to characterize time to onset and time to resolution
 for adverse events of special interest. Multivariate logistic regression will be used to
 determine the demographic and baseline characteristics most predictive of developing adverse
 events of interest. A forward selection stepwise procedure will be used to identify the
 subset of relevant factors.

 Summary tables will also be provided for clinically relevant subgroups. Analyses will be
 undertaken to explore the course of neuropathy for subjects who have pre-existing neuropathy
 at baseline. Specifically, cross-tabulations will be used to summarize changes in severity
 observed during lenalidomide treatment and summary statistics will be provided for other
 relevant variables.
Inclusion Criteria:

 -  Male or female multiple myeloma patients with ≥18 years of age.

 -  Subjects who understand and voluntarily sign an informed consent

 -  Subjects who are receiving lenalidomide treatment in combination with dexamethasone
 not longer than four weeks.

 Exclusion Criteria:

 -  - Refusal to participate in the study.

 -  Patients who are currently on an interventional clinical trial

 -  Subjects who previously received lenalidomide treatment and whose treatment is ceased
 or who had a treatment interruption for four weeks or longer.