Bortezomib and High-dose Melphalan at Myeloma Relapse
Recruitment status was Active, not recruiting
The prognosis after retreating with high-dose melphalan with stem cell support after first relapse after high-dose treatment is dependent on the time to first relapse. Bortezomib can increase chemosensitivity of e.g. melphalan. The trial aims at determining the toxicity of adding bortezomib to high-dose melphalan with stem cell support and evaluating whether the time to a second relapse can be prolonged.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Bortezomib Dexamethasone and High-dose Melphalan in Patients With Relapse After High-dose Melphalan With Autologous Stem Cell Support|
- 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 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Determining the toxicity of bortezomib as part of the high-dose melphalan conditioning [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Response rate of the second ASCT [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- Marrow regeneration [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- OS compared with the OS of matched controls from the former NMSG [ Time Frame: 3 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2007|
|Estimated Study Completion Date:||September 2010|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
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 trial.
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 progressive disease).
|Department of Haematology B, Aalborg Hospital, University of Aarhus|
|Aalborg, Denmark, 9000|
|Department of Haematology, Herlev University Hospital|
|Herlev, Denmark, 2730|
|Department of Haematology X, Odense University Hospital|
|Odense, Denmark, 5000|
|Dept. of Haematology, Århus University Hospital|
|Århus, Denmark, 8000|
|Hematologisk seksjon, med avd, Haukeland Universitetssykehus|
|Bergen, Norway, N-5021|
|Department of Hematology, Rikshospitalet|
|Hematologisk seksjon, St.Olav Hospital|
|Trondheim, Norway, N-7006|
|Department of Hematology, Sahlgrenska Sjukhuset|
|University Hospital Lund|
|Lund, Sweden, SE-221 85|
|Principal Investigator:||Peter Gimsing, M.D.||Department of Haematology, Rigshospitalet|