E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Multiple myeloma in adults. | |
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 | |
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 | To investigate if Velcade inhibits osteoclasts degeneration of bone | |
E.2.2 | Secondary objectives of the trial | investigate Velcades effect on bone metabolism | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | Patienterne med nydiagnostiseret myelomatose, som er behandlingskrævende i henhold til almindeligt accepterede kliniske kriterier. 18 år eller ældre. Kvinder i den fertile alder skal have en negativ graviditetstest, som højst må være 14 dage gammel, og patienten må erklære sig villige til at anvende effektiv antikonception i hele forsøgsperioden og 2 måneder derefter. Effektiv anticonception er p-piller, spiral, depotinjektion af gestagen, subdermal implantation, hormonal vaginalring samt transdermal depotplaster. Kondom anses ikke for at være tilstrækkelig prævention, så mandlige patienter må anmodes om at sikre sig, at hans eventuelle partner anvender én af ovenstående anticonceptionsmidler. Informeret samtykkeerklæring. Performance status < 3. Forventet levetid > 3 måneder. | |
E.4 | Principal exclusion criteria | Patienter, der ikke har givet informeret samtykke. Gravide. Forhøjet S-Ca++ Patienter i behandling med bisfosfornater. i.v. såvel som peroral. Moderat til svær sensorisk neuropati (> grad 2). Motorisk neuropati. Kendt overfølsomhed overfor Velcade eller indholdsstoffer i præparatet. | |
E.5 End points |
E.5.1 | Primary end point(s) | |
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 | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.6.13.1 | Other scope of the trial description | |
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 | 2 |
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 | Yes |
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 | The length of the trial is defined by the number of patients | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |