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

Principal Investigator

Dr Owen

Tel 01132067851

Email roger.owen@leedsth.nhs.uk

Research Nurse

Jule Bagabag

Tel 01132068577

Email julie.bagabag@leedsth.nhs.uk

Other trials currently active for Multiple Myeloma

Merck Vorinostat 095

Study of Vorinostat (MK0683), an HDAC Inhibitor, in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma after at least 2 prior treatment regimens

Merck Vorinostat 088

Study of Vorinostat (MK0683) an HDAC Inhibitor, or Placebo in Combination With Bortezomib in Patients With relapsed or refractory  Multiple Myeloma

 

Myeloma XI

Myeloma IX 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, however,

two distinct treatment pathways.

i) Intensive pathway:

 

For younger/fitter patients where intensive HDT with stem cell support

ii) Non-intensive pathway:

considered appropriate.

Although the previous MRC Myeloma VII trial, in which there was randomisation to HDT, was

restricted to patients under the age of 65, it is recognised that fit patients over this age may wish to

receive the more intensive treatment, and the decision with regard to which pathway to follow will

be a matter for discussion between the treating clinician and the patient.

For older/less fit patients where standard dose chemotherapy is

is considered appropriate.

Tags

non-interventional observational post authorisation safety study