Myeloma XI
Trial overview
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.
Inclusion criteria
Aged 18 years or greater
Newly diagnosed as having symptomatic multiple myeloma or non-secretory multiple
- Women of childbearing potential (WCBP) (see Appendix J) must agree to use TWO methods of contraception beginning 4 weeks prior to the start of thalidomide, while on thalidomide and 4 weeks after the last dose of thalidomide. The two methods of contraception must include one highly effective method and one additional effective (barrier) method, as outlined in the Pharmion Risk Management Programme. - Male patients (including those who have had a vasectomy) must use condoms when engaging in heterosexual activity with WCBP while on thalidomide and 4 weeks after the last dose of thalidomide, as outlined in the Pharmion Risk Management Programme. - WCBP must have a negative blood pregnancy test performed by a healthcare professional: - within 24 hours before starting thalidomide - every 4 weeks in women with regular menstrual cycles OR every 2 weeks in women with irregular menstrual cycles while on thalidomide - 4 weeks after the last dose of thalidomide.
myeloma (see Appendix A for definitions), based on:
- Paraprotein (M-protein) in serum and/or urine
- Bone marrow clonal plasma cells or plasmacytoma
- Related organ or tissue impairment and/or symptoms considered by the clinician to be
myeloma related
Exclusion criteria
Patients with the following characteristics are ineligible for this trial (see Appendix A for definitions):
Asymptomatic myeloma
of the skin or other in situ carcinomas 16 14 days) dexamethasone, or 1.25g prednisolone). disorders, but exclusion is essentially to be at the discretion of the treating clinician creatinine >500mol/l or urine output <400ml/day or requirement for dialysis). These patients are not eligible for this study but may be eligible for inclusion in MERIT (MyEloma Renal Impairment Trial). NB. Patients with serum creatinine 2 x upper limit of normal (or creatinine clearance <30ml/min) are eligible for Myeloma IX, but bisphosphonates should not be administered until serum creatinine has decreased to <2 x upper limit of normal (or creatinine clearance >30ml/min).
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, in Combination With Bortezomib in Patients With Relapsed or Refractory Multiple Myeloma after at least 2 prior treatment regimens
Study of Vorinostat (MK0683) an HDAC Inhibitor, or Placebo in Combination With Bortezomib in Patients With relapsed or refractory Multiple Myeloma