E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028228 |
|
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 |
The primary objective of this study is to determine best response to VELCADE re-treatment in multiple myeloma subjects who have previously responded to a VELCADE based therapy. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study are to assess the safety profile, the best confirmed M-protein response, the duration of response DOR , and time to progression TTP to VELCADE re-treatment in multiple myeloma subjects who have previously responded to VELCADE based therapy. In addition, the exploratory objective of the study is to evaluate the investigator s best response relative to the best reported response to the previous VELCADE course of treatment. |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1.Male or female subject, aged major or equal 18 years. 2.Subject previously tolerated 1.0 or 1.3 mg/m2/dose of VELCADE alone or in combination with other agents and had CR or PR upon completion of VELCADE therapy. 3.It has been major or equal 6 months since the subject s last VELCADE dose and the subject has Progressive Disease PD if prior response to VELCADE was PR or subject has relapsed from CR. 4.Subject has a Karnofsky performance status major or equal 60 5.Subject has a life-expectancy 3 months. |
|
E.4 | Principal exclusion criteria |
1.Subjects with a history of PD, minimal response, or stable disease SD on last exposure to VELCADE. 2.Subject has received chemotherapy, radiotherapy, antibody, immunotherapy, or experimental therapy to treat multiple myeloma since their last dose of VELCADE. Note Subjects can have received localized palliative radiotherapy for complications due to osteolytic bone lesions. Subjects can have received steroids cumulative exposure of up to 160 mg of Dexamethasone or equivalent or thalidomide or Interferon as maintenance therapy since their last dose of VELCADE. Subjects can have received high dose therapy/stem cell transplantation after VELCADE containing induction regimen, only if PR or CR was observed during VELCADE containing induction therapy. 3.Subjects who achieved a CR or PR but relapsed while on therapy. 4.Subject has oligosecretory or non-secretory multiple myeloma. 5.Subject has an uncontrolled or severe cardiovascular disease, including myocardial infarction within 6 months of enrolment or had New York Heart Association NYHA Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 6.Subject has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To determine best response to VELCADE re-treatment in multiple myeloma subjects who have previously responded to a VELCADE based therapy. |
|
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 | Information not present in EudraCT |
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 | Yes |
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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |