E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
relapsed and refractory Multiple Myeloma |
mieloma múltiple en recidiva y refractario |
|
E.1.1.1 | Medical condition in easily understood language |
Multiple Myeloma |
mieloma múltiple |
|
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 | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028228 |
E.1.2 | Term | Multiple myeloma |
E.1.2 | System Organ Class | 100000004864 |
|
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 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 |
evaluar el beneficio clínico y la seguridad de la combinación de Nivolumab, pomalidomida y dexametasona (N-Pd el brazo en investigación), cuando se compara como pomalidomida y dexametasona (Pd; brazo control) en sujetos con mieloma múltiple en recidiva y/o refractario. |
|
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 |
- Evaluar el tiempo hasta la respuesta objetiva (THR) dentro de los brazos de N-Pd y Pd. - Evaluar la duración de la respuesta objetiva (DdR) dentro de los brazos de N-Pd y Pd. - Evaluar la TRO y la SLP según el investigador dentro de los brazos de N-Pd y Pd. |
|
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 |
- Enfermedad medible. - Haber recibido ≥ de 2 líneas de tratamiento previo que incluyera al menos 2 ciclos de un fármaco inmunomodulador (IMID) y un inhibidor de proteosoma solos o en combinación. - Progresión documentada desde el tratamiento más reciente. |
|
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) |
- únicamente plasmocitoma solitario del hueso o extramedular. - leucemia activa de células plasmáticas. - gammapatía monoclonal de significado incierto (MGUS) mieloma múltiple asintomático (SMM), amiloidosis, macrobulinemia de Waldenstrom o síndrome de POEMS (discrasia celular plasmática con polineuropatía, organomegalia, endocrinopatía, proteínas monoclonales y cambios en la piel). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Objective response rate (ORR) 2.Progression free survival (PFS) |
1. Tasa de respuestas objetivas (TRO). 2. Supervivencia libre de progresión (SLP). |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1.Appromixately 18 months from the time of first patient randomization. 2. Approximately 23 months from the FPFV to PFS event goal |
1. Aproximadamente 18 meses desde la aleatorización del primer paciente. 2. Aproximadamente 23 meses desde la primera visita del primer paciente hasta el target de eventos de SLP. |
|
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. Evaluar el tiempo hasta la respuesta objetiva (THR). 2. Evaluar la duración de la respuesta objetiva (DdR). 3. Evaluar la TRO y la SLP según el investigador. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Approximately 23 months from the FPFV to PFS event goal 2. Approximately 23 months from the FPFV to PFS event goal 3. Approximately 23 months from the FPFV to PFS event goal |
1. Aproximadamente 23 meses desde la primera visita del primer paciente hasta el target de eventos de SLP. 2. Aproximadamente 23 meses desde la primera visita del primer paciente hasta el target de eventos de SLP. 3. Aproximadamente 23 meses desde la primera visita del primer paciente hasta el target de eventos de SLP. |
|
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 |
Evaluaciones de inmunogenicidad Evaluaciones de biomarcadores |
|
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 | 5 |
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 | No |
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 |
|
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
|
LVLS |
Última Visita del Último Paciente |
|
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 | |
E.8.9.2 | In all countries concerned by the trial years | 4 |