E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Myelomatose med andet eller senere relaps af sygdommen. |
|
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 | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
At evaluere tolerabilitet og sikkerhed af behandlingen. |
|
E.2.2 | Secondary objectives of the trial |
At belyse hvorvidt vaccination med peptider deriveret fra Bcl-2 familien, administreret i kombination med montanide ISA-50V kan inducere et målbart cellulært T celle respons, når vaccinen benyttes til patienter med myelomatose.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Histologisk verificeret myelomatose (diagnostiske kriterier se appendix I). Recidiv af sygdommen, hvor Velcade som enkeltstof tænkes anvendt som relapsbehandling. 2. Evaluérbar sygdom – dog kan patienter med klinisk ikke-evaluérbar sygdom (non-sekretorisk myelomatose) indgå i Fase I delen. 3. Besiddelse af vævstype HLA-A1, HLA-A2 og/eller HLA-A3. 4. Alder >18 år 5. Performance status < 2 (ECOG-skala) 6. Forventet levetid > 3 måneder 7. Adækvat knoglemarvsfunktion d.v.s. a. Leukocyttal > 2,5 x 109/l b. Granulocyttal > 1,5 x 109/l c. Trombocyttal > 50 x 109/l 8. Kreatinin < 2,5 x øvre normal grænse d.v.s. kreatinin < 300 µmol/l 9. Adækvat leverfunktion d.v.s. a. ASAT < 100 IU b. Bilirubin < 30 IU 10. Kvinder i fertil alder skal have negativ graviditetstest inden for 7 dage forud for inklusion i undersøgelsen og anvende sikker prævention. P-piller, depotgestagen og spiral betragtes som sikre svagerskabsforebyggende metoder 11. Underskrevet informeret samtykke.
|
|
E.4 | Principal exclusion criteria |
1. Andre maligne tumorer i anamnesen. Patienter behandlet for anden malign lidelse kan indgå såfremt patienten er uden tegn til sygdom mindst 5 år efter afsluttet behandling. 2. Betydende medicinsk lidelse efter investigators skøn, fx svær astma/COLD, en dårligt reguleret hjertekar sygdom, insulinkrævende diabetes mellitus. 3. Akut/kronisk infektion med f. eks. HIV, hepatitis, tuberculosis 4. Alvorlig allergi eller tidligere anafylaktiske reaktioner 5. Aktiv autoimmune sygdomme, fx. autoimmun neutropeni/trombocytopeni eller hæmolytisk anæmi, systemisk lupus erythematosus, Sjøgrens syndrom, sclerodermi, myastenia gravis, Goodpastures syndrom, Addisons sygdom, Hashimotos tyroiditis, aktiv Graves sygdom. 6. Gravide og ammende kvinder. 7. Fertile kvinder som ikke anvender effektiv svangerskabsforebyggelse. 8. Samtidig behandling med immunsupprimerende medicin (herunder prednisolon, methotrexat mm.). 9. Samtidig behandling med andre eksperimentelle stoffer. 10. Samtidig anden systemisk anticancerbehandling – der undtages behandling med bisfosfonater. 11. Patienter med aktiv ukontrolleret hyperkalcæmi. 12. Patienter må ikke have modtaget kemoterapi, immunterapi eller bestråling (ud over lokalt) indenfor de seneste 28 dage
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Tolerabiliteten og sikkerheden ved vaccinationen vil blive bedømt ved registrering af alle bivirkninger og mulige uønskede hændelser i relation til behandlingen i henhold til CTC kriterier. |
|
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 | 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 | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
| |
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 | |
E.8.9.1 | In the Member State concerned days | |