Merck Vorinostat 088

Trial overview

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

 

Inclusion criteria

- Patient is 18 years of age or older

- Patient has an established diagnosis of multiple myeloma based on the myeloma diagnostic criteria
- Patient has received at least 1 but not more than 3 prior anti-myeloma regimens and has progressive disease after the most recent treatment regimen
- Patient must have adequate organ function

 

Exclusion criteria

- Patient has had a prior allogeneic bone marrow transplant or plans to undergo any type of bone marrow transplantation within 4 weeks of the initiation of study therapy
- Patient has known hypersensitivity to any components of bortezomib or vorinostat
- Patient has active Hepatitis B or C, plasma cell leukemia, or is HIV positive
- Patient has had prior treatment with vorinostat or HDAC inhibitors

Contact details

Prinicpal Investigator

Dr Gordon Cook

Tel 01132068433

Email gordon.cook@leedsth.nhs.uk

Senior Research Nurse

David Buchanan

Tel 01132068577

Email david.buchanan@leedsth.nhs.uk



Other trials currently active for Multiple Myeloma

Celgene PASS

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

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

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

relapsed multile myeloma refractory multiple myeloma