E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
relapsed and refractory Multiple Myeloma |
MIELOMA MULTIPLO recidivato e refrattario |
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E.1.1.1 | Medical condition in easily understood language |
Multiple Myeloma |
MIELOMA MULTIPLO |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028228 |
E.1.2 | Term | Multiple myeloma |
E.1.2 | System Organ Class | 100000004864 |
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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 |
valutare il beneficio clinico e la sicurezza della combinazione terapeutica di Nivolumab, Pomalidomide e Desametasone (N-PD braccio investigativo) paragonato al braccio di controllo ( Pd-Pomalidomide e desametasone) in soggetti con mieloma multiplo recidivato e refrattario |
To evaluate the clinical benefit and safety of the combination therapy of Nivolumab, pomalidomide, and dexamethasone (N-Pd the investigational arms, when compared to pomalidomide and dexamethasone (Pd; the control arm) in subjects with relapsed and refractory multiple myeloma |
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E.2.2 | Secondary objectives of the trial |
-To assess the time to objective response (TTR) within N-Pd and Pd arms - To assess the duration of objective response (DOR) within N-Pd and Pd arms -To assess ORR and PFS by Investigator within N-Pd and Pd arms |
• Valutare il tempo alla risposta obiettiva (time to response, TTR) nei bracci N-Pd e Pd • Valutare la durata della risposta obiettiva (duration of response, DOR) nei bracci N-Pd e Pd • Valutare ORR e PFS da parte dello sperimentatore nei bracci N-Pd e Pd
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Measurable Disease -Have received≥ 2 lines of prior therapy which must have included at least 2 consecutive cycles of an immune modulatory drug (IMID) and a proteasome inhibitor alone or in combination. -Documented progression from most recent therapy |
Soggetti con diagnosi di mieloma multiplo refrattario o recidivante definiti come segue: 1. Sono affetti da malattia misurabile 2. Soggetti che abbiano ricevuto >2 pregresse linee di terapia che abbiano incluso almeno 2 cicli consecutivi di un farmaco immunomodulante (immunomodulatory drug, IMID) e un inibitore del proteasoma in monoterapia o in terapia combinata 3. Mieloma multiplo recidivante o refrattario (R/R) documentato 4. Progressione documentata dalla più recente terapia
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E.4 | Principal exclusion criteria |
-Solitary bone or extramedullary plasmacytoma disease only -Active plasma cell leukemia -monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) |
osso solitario o malattia plasmocitoma extramidollare leucemia attiva a cellule del plasma gammopatia monoclonale di significato indeterminato (MGUS) smoldering mieloma multiplo (SMM), amiloidosi, macroglobulinemia di Waldenstrom o sindrome POEMS (discrasia delle plasmacellule con poli neuropatia, organomegalia, endocrinopatia, proteina monoclonale e cambiamenti nella pelle)
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Objective response rate (ORR) 2.Progression free survival (PFS) |
1. tasso di risposta obiettiva (ORR) 2. sopravvivenza libera da progressione (PFS)
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1.Appromixately 18 months from the time of patient enrollment 2. Approximately 23 months from the time of patient enrollment |
1. approssimativamente 18 mesi dall’arruolamento del paziente 2. approssimativamente 23 mesi dall’arruolamento del paziente
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E.5.2 | Secondary end point(s) |
1.To assess the time to objective response (TTR) 2.To assess the duration of objective response (DOR) 3.ORR and PFS by Investigator |
1. valutare il tempo di risposta obiettiva (TTR) 2. valutare la durata della risposta obiettiva (DOR) 3.ORR e PFS dall’ Investigatore
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1.Approximately 23months from the time of patient enrollment 2.Approximately 23 months from the time of patient enrollment 3.Approximately 23 months from the time of patient enrollment |
1. approssimativamente 23 mesi dall’arruolamento del paziente 2. approssimativamente 23 mesi dall’arruolamento del paziente 3. approssimativamente 23 mesi dall’arruolamento del paziente
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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 |
Immunogenicity Assessments, Biomarker Assessments |
Immunogenicity Assessments, Biomarker Assessments |
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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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Canada |
Czech Republic |
Denmark |
Germany |
Greece |
Israel |
Italy |
Norway |
Spain |
Sweden |
Switzerland |
United States |
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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
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
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 |