E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Myeloma patients progressing or relapsing after allogeneic transplantation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028228 |
E.1.2 | Term | Multiple myeloma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Treatment efficacy in progressing or relapsing patients |
|
E.2.2 | Secondary objectives of the trial |
- 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 |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care - Female subject is either post-menopausal or surgically sterilized or willing to use an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. |
|
E.4 | Principal exclusion criteria |
- 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of stringent clinical complete remission, complete remission and partial remission |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |