Multiple Myeloma
Conditions
Keywords
Pomalidomide, Multiple Myeloma, Relapsed, Refractory, Observational, Imnovid, Registry, Post-approval, Safety
Brief summary
This registry is a prospective, multi-center, observational study and will collect safety data on multiple myeloma adult patients who have received at least two prior therapies and take IMNOVID (pomalidomide) as part of standard care. The registry will remain open until 500 patients will have received at least 3 cycles of pomalidomide. All patients registered will be followed for up to 3 years after the informed consent date or until death or withdrawal of consent. During this time the incidence of second primary malignancies (SPM), overall survival and any occurrence of a pregnancy will be assessed.
Interventions
DRUGIMNOVID
IMNOVID (pomalidomide) as prescribed in routine clinical practice
Sponsors
Celgene
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Understand and voluntarily sign an informed consent form, if applicable, and have never been previously treated with pomalidomide before their inclusion in the Registry. Patients with symptomatic, measurable relapsed and refractory multiple myeloma who have received at least two prior treatment regimens, including both bortezomib and lenalidomide and have demonstrated disease progression on the last therapy and are commencing a pomalidomide based treatment.
Exclusion criteria
Refusal to participate in the Registry or currently participating in the treatment phase of an interventional clinical trial. Pregnancy. Women of childbearing potential, unless all the conditions of the pregnancy prevention program are met. Male patients unable to follow or comply with the required contraceptive measures. Hypersensitivity to the active substance or to any of the excipients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determine incidence of risks as outlined in the Risk Management Plan | Up to 3 years | To characterize and determine the incidence of important identified and potential risks as outlined in the risk management plan (RMP) among previously treated multiple myeloma patients who are currently being treated with IMNOVID (pomalidomide) in a post-marketing setting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy Prevention Programme Effectiveness | Up to 3 years | To describe and assess the effectiveness, implementation and compliance of the Celgene Pregnancy Prevention Programme for patients recruited in this registry |
| Previous Treatments | Approximately 6 months | To describe the type of myeloma treatment administered immediately prior to receiving IMNOVID (pomalidomide). |
Countries
Belgium, Denmark, Germany, Italy, Norway, Spain, Sweden, United Kingdom
Outcome results
None listed