Merck Vorinostat 095
Trial overview
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
Inclusion criteria
- Patient is 18 years of age or older
- Patient has an established diagnosis of multiple myeloma based on myeloma diagnostic criteria
- Patient must have adequate organ function
- Patient is refractory to prior bortezomib regimen and have also been exposed to prior IMiD (thalidimide or lenalidmide)
- Patient has relapsed and refractory multiple myeloma after at lest 2 prior treatment regimens
- Patient is relapsed, refractory, intolerant, and/or ineligible (in the opinion of the investigator) to other therapies including an IMiD (thalidomide OR lenalidomide)
- Patient is refractory to bortezomib (no response on prior bortezomib containing regimen or progression on or within 60 days of bortezomib containing regimen
Exclusion criteria
- Patient has known hypersensitivity to any components of bortezomib or vorinostat
- 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
Contact details
Other trials currently active for Multiple Myeloma
A non-interventional observational post authorisation safety study of subjects treated with lenalidomide
Study of Vorinostat (MK0683) an HDAC Inhibitor, or Placebo in Combination With Bortezomib in Patients With relapsed or refractory Multiple Myeloma
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.
is considered appropriate.
Tags
vorinostat hdac inhibitor relapsed multiple myeloma refractory multiple myeloma after 2 prior treatments mecrk 095