E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multiple Myeloma |
Mieloma Múltiple |
|
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 | 21.0 |
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 |
To provide elotuzumab and/or other study drugs to subjects who have participated on a prior protocol investigating elotuzumab who are not able to receive commercial drug supply. |
Proporcionar elotuzumab y/u otros fármacos del estudio a sujetos que hayan participado en un protocolo previo que investigue elotuzumab que no puedan recibir el suministro de fármacos comercializados. |
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E.2.2 | Secondary objectives of the trial |
To monitor the safety and tolerability of elotuzumab |
Supervisar la seguridad y tolerabilidad de elotuzumab. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Participated in a previous elotuzumab protocol (including, but not limited to HuLuc63-1703, CA204007, CA204009, or CA204011) and is deemed by the investigator to be deriving benefit from elotuzumab and/or other study drugs as defined by the previous protocol. - Receiving elotuzumab and/or other study drugs at the time of signature of informed consent. - Males and Females, ages 18 or local age of majority and older, inclusive. |
- Haber participado en un protocolo previo de elotuzumab (incluidos, entre otros, HuLuc63-1703, CA204007, CA204009 o CA204011) y estar recibiendo beneficio de elotuzumab y/u otros fármacos del estudio, a criterio del investigador, según lo definido por el protocolo anterior. - Estar recibiendo elotuzumab y/u otros fármacos del estudio en el momento de la firma del consentimiento informado. - Hombres y mujeres ≥18 años o de mayoría de edad de acuerdo a las normas locales. |
|
E.4 | Principal exclusion criteria |
- All subjects previously discontinued from an elotuzumab study for any reason. - Subjects not receiving clinical benefit from previous study therapy. - Subjects who are not medically well enough to receive study therapy as determined by the investigator.
Other protocol defined inclusion/exclusion criteria could apply. |
- Todos los sujetos deberán haber abandonado previamente, por cualquier razón, un estudio con elotuzumab. - Sujetos que no se estaban beneficiando clínicamente del tratamiento de su estudio previo. - Sujetos que, en opinión del investigador, no se encuentran suficientemente bien desde el punto de vista médico para recibir el tratamiento del estudio.
Pueden ser válidos otros criterios de inclusión/exclusión definidos por el protocolo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The number of subjects who received at least one dose of elotuzumab or backbone therapy (other study drugs) and the duration of treatment will be collected. |
Se recogerá el número de sujetos que hayan recibido como mínimo una dosis de elotuzumab o del tratamiento de fondo (distinto de los medicamentos del estudio) y también la duración del tratamiento. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Maximum duration is until all subjects have discontinued study drugs, or until all subjects are treated for up to 2 years |
El estudio continuará hasta que todos los sujetos hayan interrumpido los fármacos del estudio o hasta que todos los sujetos hayan recibido tratamiento durante un máximo de 2 años. |
|
E.5.2 | Secondary end point(s) |
In this study, all SAEs, Grade 5 AEs, AEs previously not reported, AEs leading to discontinuation will be collected. Adverse events and other symptoms will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE). |
En este estudio se recogerán todos los acontecimientos adversos graves, acontecimientos adversos de Grado 5, acontecimientos adversos no comunicados previamente y acontecimientos adversos que lleven al abandono del tratamiento. Los acontecimientos adversos y otros síntomas/signos se clasificarán en grados de acuerdo a los NCI Common Terminology Criteria for Adverse Events (CTCAE). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Maximum duration is until all subjects have discontinued study drugs, or until all subjects are treated for up to 2 years |
El estudio continuará hasta que todos los sujetos hayan interrumpido los fármacos del estudio o hasta que todos los sujetos hayan recibido tratamiento durante un máximo de 2 años. |
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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 | No |
E.6.4 | Safety | Yes |
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 |
Continuation roll-over that will provide elotuzumab and/or other study drugs to subjects who are currently receiving this therapy on another elotuzumab clinical trial who are not able to receive commercial drug supply. |
Habrá un estudio de continuación en el que se facilitará elotuzumab y otros fármacos del estudio a los sujetos que estén recibiendo actualmente este tratamiento en otro ensayo clínico con elotuzumab pero que no puedan recibir tratamiento con fármaco comercializado. |
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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) | 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 | No |
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 | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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 |
Belgium |
Canada |
Greece |
Italy |
Poland |
Romania |
Spain |
Turkey |
United Kingdom |
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
|
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |