Bortezomib and High-dose Melphalan at Myeloma Relapse
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|ClinicalTrials.gov Identifier: NCT00508209|
Recruitment Status : Unknown
Verified June 2010 by Nordic Myeloma Study Group.
Recruitment status was: Active, not recruiting
First Posted : July 27, 2007
Last Update Posted : June 22, 2010
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: bortezomib||Phase 2|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||June 2009|
|Estimated Study Completion Date :||September 2010|
- Drug: bortezomib
1.3 mg/sqm days -5 and -2 in connection with high-dose melphalan (200mg/sqm day -2) and autologous stem cell supportOther Name: Velcade
- 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 ]
- Determining the toxicity of bortezomib as part of the high-dose melphalan conditioning [ Time Frame: 3 years ]
- Response rate of the second ASCT [ Time Frame: 3 years ]
- Marrow regeneration [ Time Frame: 3 years ]
- OS compared with the OS of matched controls from the former NMSG [ Time Frame: 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00508209
|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|