Celgene PASS
Trial overview
A non-interventional observational post authorisation safety study of subjects treated with lenalidomide
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.
Contact details
Other trials currently active for Multiple Myeloma
Myeloma XI is intended to be a unifying trial addressing issues in patients of all ages and providing a strategy within which to introduce new treatments as they become available.
There are two distinct treatment pathways.
Intensive pathway: for younger/fitter patients where intensive HDT with stem cell support is considered appropriate. Comparing a thalidomide-containing regimen with a lenalidomide-containing regimen, as induction treatment prior to HDT.
Non-intensive pathway: for older/less fit patients where standard-dose chemotherapy is considered appropriate. To compare an attenuated thalidomide-containing regimen with an attenuated lenalidomide-containing regimen.
Phase II strudy of Bortezomib, Adriamycin and Dexamethasone (PAD) therapy for previously untreated patients with multiple myeloma: Impact of minimal residual disease (MRD) in patients with deferred ASCT.
The overall aim of the trial is to provide a reliable estimate of the 2-year PFS for patients who receive no further treatment after achieving a major response to induction therapy with PAD.
Tags
non-interventional observational post authorisation safety study