E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
multiple myeloma patients with relapse or progression of their disease after receiving an allogeneic stem cell transplantation |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
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 |
Investigation of the efficacy of bortezomib combined with Donor Lymphocyte Infusion in patients with relapsed or progressive multiple myeloma following (non) myeloablative allo-SCT as measured by - response rate including percentage of complete remission according to EBMT criteria - event free survival (EFS) (i.e. time from registration to progression or death from any cause whichever occurs first) and overall survival (OS).
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E.2.2 | Secondary objectives of the trial |
Investigation of the - toxicity of DLI in combination with bortezomib including evaluation of GvHD and CTC grade toxicity - evaluation of immune modulating effects of combined treatment consisting of DLI and bortezomib as measured by serial blood samples
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Male or female and at least 18 years-of-age - MM patients with any type of relapse or progressive disease following (non) myeloablative allo-SCT for which DLI is considered a treatment option (including patients previously participating in Hovon 54 or Hovon 65 studies) - Informed consent - Haematological parameters; Hb > 4.0 mmol/L, leucocytes > 1.0×109/L , thrombocytes > 25 ×109/L, with or without transfusion
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E.4 | Principal exclusion criteria |
- use of immunosuppressive drugs, for example cyclosporin, MMF, corticosteroids - existing GvHD > grade A - any non-hematological toxicity CTC grade ≥ 3 - neuropathy CTC grade ≥ 2 - pregnancy - previous use of bortezomib is not an exclusion criterion, however patients refractory to bortezomib during previous treatment are excluded from this study
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E.5 End points |
E.5.1 | Primary end point(s) |
-CTC toxicity grade 4 -GvHD grade D -Response
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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 | Yes |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
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 | No |
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
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follow-up 2 years after the last study treatment of the the last subject |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |