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 | 18.1 |
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 compare progression free survival (PFS) between treatment arms |
Comparar la supervivencia libre de progresión (SLP) entre los brazos de tratamiento. |
|
E.2.2 | Secondary objectives of the trial |
- To compare objective response rate between treatment arms - To compare overall survival between treatment arms |
- Comparar la tasa de respuesta objetiva entre los brazos de tratamiento - Comparar la supervivencia global entre los brazos de tratamiento |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
(1) ? 2 prior lines of therapy which must have included at least 2 consecutive cycles of lenalidomide and a proteosome inhibitor alone or in combination. (2) Documented refractory or relapsed and refractory multiple myeloma (3) Refractory to proteosome inhibitor and lenalidomide, and to their last treatment (4) Relapsed and refractory patients had achieved at least a partial response to previous treatment with proteosome inhibitor or lenalidomide, or both, but progressed within 6 months, and were refractory to their last treatment.
(5) Measurable disease at screening
(6) Eastern Cooperative Oncology Group (ECOG) performance status ? 2 |
(1) ? 2 líneas de tratamiento previas que deben haber incluido al menos 2 ciclos consecutivos de lenalidomida y un inhibidor del proteosoma solo o en combinación. (2) Mieloma múltiple refractario o en recidiva y refractario documentado (3) Refractario a un inhibidor de proteosoma o lenalidomida, y a su último tratamiento (4) Pacientes en recidiva o refractarios que habían alcanzado al menos una respuesta parcial al tratamiento previo con inhibidor del proteosoma o lenalidomida, o ambos, pero progresaron en el plazo de 6 meses y fueron refractarios a su último tratamiento. (5) Enfermedad medible en la selección (6) Estado funcional del Eastern Cooperative Oncology Group (ECOG) ? 2. |
|
E.4 | Principal exclusion criteria |
(1) Active plasma cell leukemia (2) Prior treatment with pomalidomide (3) Unable to tolerate thromboembolic prophylaxis while on the study (4) Prior autologous stem cell transplant within 12 weeks (5) Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C |
(1) Leucemia activa de células plasmáticas (2) Tratamiento previo con pomalidomida (3) Incapaz de tolerar la profilaxis tromboembólica durante el estudio (4) Trasplante autólogo previo de células progenitoras hematopoyéticas en el plazo de las 12 semanas anteriores de la primera dosis de fármaco del estudio (5) Infección conocida por VIH o Hepatitis activa A, B o C |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Progression Free Survival (PFS) |
Supervivencia Libre de Progresión (SLP) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
PFS will be defined as the time, in months, from randomization to the date of the firstdocumented tumor progression or death due to any cause.Time Frame: Every 4 weeks relative to the first dose of study medication, until progressive disease. |
La SLP se definirá como el tiempo, en meses, desde la aleatorización hasta la fecha de la primera progresión tumoral documentada o la muerte debida a cualquier causa. Intervalos: Cada 4 semanas respecto a la primera dosis del fármaco de estudio, hasta progresión de la enfermedad. |
|
E.5.2 | Secondary end point(s) |
(1) Objective Response Rate (ORR) is defined as the proportion of randomized subjects who achieve a best response of partial response (PR) or better.(2) Overall Survival (OS) defined as the period of time from randomization until the date of death or last known alive date. |
(1) La tasa de respuesta objetiva (TRO) se define como la proporción de sujetos aleatorizados que alcancen la mejor respuesta de respuesta parcial (RP) o mejoren. (2) La supervivencia global (SG) se define como el tiempo desde la aleatorización hasta la muerte por cualquier causa o última fecha en que se sabía que el sujeto estaba vivo. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
(1) ORR - All response endpoints will be assessed every 4 weeks after the start of study therapy, and until progressive disease occurs. (2) OS will be assessed every 12 weeks, or more frequently, in the Follow Up Phase of the trial. |
(1) TRO - Todas las variables de respuesta se evaluarán cada 4 semanas desde el inicio del fármaco de estudio, y hasta el comienzo de la progresión de la enfermedad. (2) La SG se evaluará cada 12 semanas, o con mayor frecuencia, en la Fase de Seguimiento del ensayo. |
|
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 | 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 | 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 | 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 | No |
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 | 2 |
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 | 30 |
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 |
Canada |
France |
Germany |
Greece |
Italy |
Japan |
Netherlands |
Spain |
United States |
|
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
|
LVLS |
Última visita del último sujeto. |
|
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 | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |