A non-interventional observational post authorisation safety study of subjects treated with lenalidomide.

Study Objective

Primary

• To characterize and determine the incidence of adverse events of special interest; specifically neutropenia, thrombocytopenia, acute and opportunistic infections, bleeding events, venous thromboembolism, cardiac disorders (cardiac failure, arrhythmia, QT prolongation), neuropathy, rash, hypersensitivity, hypothyroidism and renal failure in subjects treated with lenalidomide in a naturalistic setting and placing into context with the background incidence of these adverse events in a non-lenalidomide cohort of multiple myeloma subjects who newly receive 2nd or later lines of treatment for multiple myeloma.

Secondary

• To monitor the evolution or resolution of neuropathy in subjects taking lenalidomide who have pre-existing neuropathy at baseline.
• Identification of new safety signals for lenalidomide treated subjects (with 95% confidence that the event does not occur at a higher frequency than 1 in 500).
• To monitor the compliance with the requirements for pregnancy testing and effective contraception in women of childbearing potential (WCBP) and the requirements for counselling of all subjects treated with lenalidomide.

Participation conditions

Inclusion Criteria:

• All subjects: Understand and voluntarily sign an informed consent form.
• Lenalidomide cohort: Subjects who are commencing lenalidomide treatment.
• Background cohort: Subjects with multiple myeloma who have received at least one prior therapy and are commencing a new therapy but not lenalidomide.

Exclusion Criteria:

• All subjects: Refusal to participate in the study or currently participating in an interventional clinical trial.
• Lenalidomide cohort: Subjects who have previously taken lenalidomide either as part of normal prescribing practice or in a clinical trial.
• Background cohort: Subjects commencing a new line of treatment having previously been enrolled in the study when treated with an earlier line of treatment.

NB. Subjects previously enrolled into this study and subsequently prescribed lenalidomide can be recruited into this study as part of the lenalidomide cohort.

Oncologists at Centre Hospitalier de Luxembourg

Oncologists at Centre Hospitalier Emile Mayrisch