Spots Global Cancer Trial Database for Bortezomib and High-dose Melphalan at Myeloma Relapse

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Trial Identification

Brief Title: Bortezomib and High-dose Melphalan at Myeloma Relapse

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 ID: NCT00508209

Conditions

Multiple Myeloma

Interventions

bortezomib

Study Description

Brief Summary: 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.

Detailed Description: 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).