Phase II Study of Bortezomib Dexamethasone and High-dose Melphalan in Patients With Relapse After High-dose Melphalan With Autologous Stem Cell Support
Patients with multiple myeloma who have their first treatment demanding relapse after an
initial treatment with high-dose melphalan with autologous stem cell support and who have
more than 2.0 x 10^6 CD34+ stem cells pr kg bodyweight in the freezer can be included in the
After disease status with basic clinical biochemistry, M-protein in blood and urine, bone
marrow investigation including immunophenotyping and total skeletal x-ray the patients are
treated with three courses of standard bortezomib (1.3 mg/sqm Days 1,4,8,11) and
dexamethasone 20 mg days 1,2,4,5,8,9,11,12. Within 4 weeks the patients receive bortezomib
days -5 and -2, high-dose melphalan (200 mg/sqm) day -2, and subsequent at least 2.0 x 10^6
CD34+ stem cells pr kg body weight.
The first month after high-dose therapy the patients are followed closely for toxicity
according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI
CTCAE), Version 3.0.
The patients are evaluated for response according to EBMT criteria and for event (death or
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of the event free survival after first high-dose melphalan with stem cell support (ASCT) and a second ASCT combined with bortezomib treatment of first relapse
Peter Gimsing, M.D.
Department of Haematology, Rigshospitalet
Denmark: Danish Medicines Agency