Bortezomib and dexamethasone treatment before donor lymphocyte infusions for myeloma patients progressing or relapsing after allogeneic transplantation of hematopoietic cells - ND
- Conditions
- Myeloma patients progressing or relapsing after allogeneic transplantationMedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2006-004815-24-IT
- Lead Sponsor
- FONDAZIONE MICHELANGELO - AVANZAMENTO DELLO STUDIO E CURA DEI TUMORI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 40
- Age 18 and 70years - Multiple myeloma relapsing or progressing more than 100 days after allo-HSCT from HLA-identical related, family mismatched one antigen or unrelated donor transplants - Donor willing to donate lymphocytes - Measurable disease M-component, Bence Jones proteinuria, BM plasmacytosis, extramedullary masses, serum free light-chains - Off treatment with immunesuppressive drugs since 5 weeks - To have not received any additional treatment chemotherapy, thalidomide, etc. for multiple myeloma for the current relapse/progression - To have not received bortezomib after allo-HSCT - Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care - Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence for the duration of the study - Male subject agrees to use an acceptable method for contraception for the duration of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
- Active GVHD - Patients receiving immunesuppressive treatment - Platelet count lower than 70.000/ L - CNS myeloma - Grade 2 peripheral neuropathy within 14 days before enrollment - Pregnancy or lactating status. Confirmation that the subject is not pregnant must be established by a negative serum 61538;-human chorionic gonadotropin 61538;-hCG pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. - SGOT and SGPT more than 3 times the upper limit of the normal range of the laboratory were the analyses are performed - Total serum bilirubin more than 2 times the upper limit of the normal range of the laboratory were the analyses are performed - Serum creatinine more than 2 times the upper limit of the normal range of the laboratory were the analyses are performed - Hypersensitivity to bortezomib, boron or mannitol - Uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months of enrolment, New York Heart Association NYHA Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis. - Serious infections, medical or psychiatric illness likely to interfere with participation in this clinical study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Treatment efficacy in progressing or relapsing patients;Secondary Objective: - incidence of grade II IV acute graft-versus-host disease and chronic graft-versus-host disease - incidence of graft failure - progression-free survival - overall survival - safety grade 3-4 toxicities according to CTC-3 criteria ;Primary end point(s): Number of stringent clinical complete remission, complete remission and partial remission
- Secondary Outcome Measures
Name Time Method