A Post Authorisation Registry of IMNOVID (Pomalidomide) for Patients With Relapsed and Refractory Multiple Myeloma.
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Details and patient eligibility
About
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.
Enrollment
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Volunteers
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.
Trial design
775 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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