E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Multiple myeloma |
Mieloma multiplo |
|
E.1.1.1 | Medical condition in easily understood language |
Multiple myeloma
|
Mieloma multiplo |
|
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 |
|
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 |
The objective of this study is to provide early access to daratumumab treatment and collect additional safety data while the medication is not commercially available for subjects with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD. |
L'obiettivo di questo studio ¿ fornire accesso precoce al trattamento con daratumumab e raccogliere dati aggiuntivi sulla sicurezza mentre il farmaco non ¿ ancora disponibile in commercio per i soggetti con mieloma multiplo che hanno ricevuto almeno 3 precedenti linee terapeutiche tra cui un inibitore del proteasoma (PI) e un agente immunomodulatore (IMiD) o la cui malattia ¿ refrattaria sia a un PI che a un IMiD. |
|
E.2.2 | Secondary objectives of the trial |
There is no hypothesis associated with this objective. |
Non ci sono ipotesi associate a questo obiettivo |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Subject must be at least 18 years of age - Subject must have documented multiple myeloma and have evidence of disease progression on or after the most recent prior treatment regimen as defined by IMWG criteria: Subjects who have received at least 3 prior lines of therapy including a proteasome inhibitor (greater than or equal to [>=] 2 cycles or 2 months of treatment) and an IMiD (>= 2 cycles or 2 months of treatment) in any order during the course of treatment (except for subjects who discontinued either of these treatments due to a severe allergic reaction within the first 2 cycles/months) OR Subjects whose disease is double refractory to a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD). For subjects who have received more than 1 type of PI, their disease must be refractory to the most recent one. Similarly, for those who have received more than 1 type of IMiD, their disease must be refractory to the most recent one - Subject must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1,or 2 - A woman of childbearing potential must have a negative serum or urine pregnancy test at Screening - A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control during the study, and all men must also not donate sperm during the study and for 6 months after receiving the last dose of study drug
|
-Il soggetto deve avere almeno 18 anni. -Il soggetto deve presentare un mieloma multiplo documentato ed evidenza di malattia in progressione contestualmente a o dopo il regime di trattamento precedente più recente in base ai criteri IMWG : • Soggetti che hanno ricevuto almeno 3 linee terapeutiche precedenti tra cui un inibitore del proteasoma (= 2 cicli o 2 mesi di trattamento) e un IMiD (= 2 cicli o 2 mesi di trattamento) in un qualsiasi ordine nel corso del trattamento (tranne per soggetti che hanno interrotto uno dei trattamenti a causa di una grave reazione allergica entro i primi 2 cicli/mesi).
OPPURE • Soggetti con doppia refrattarietà della malattia a un PI e un IMiD. Per i soggetti che hanno ricevuto più di un tipo di PI, la malattia deve essere refrattaria al più recente. In modo analogo, per i soggetti che hanno ricevuto più di un tipo di IMiD, la malattia deve essere refrattaria al più recente.
-Il soggetto deve presentare un punteggio dello stato di performance ECOG pari a 0, 1 o 2 -Le donne in età fertile devono presentare un test di gravidanza sul siero o sulle urine con risultato negativo allo screening. -Un uomo che è sessualmente attivo con una donna in età fertile e che non è stato sottoposto a vasectomia deve acconsentire a usare un metodo contraccettivo a barriera (ad es. o un profilattico con schiuma/gel/film/crema/supposta spermicida o la partner deve indossare un cappuccio occlusivo [diaframma o cappuccio cervicale] con schiuma/gel/film/crema/supposta spermicida) durante lo studio; inoltre tutti gli uomini non devono donare sperma durante lo studio e per 6 mesi dopo l'ultima dose del farmaco sperimentale.
|
|
E.4 | Principal exclusion criteria |
- Ever enrolled in another daratumumab study or eligible for enrollment in another ongoing clinical study of daratumumab - Subject receives any other anti-myeloma therapy while receiving daratumumab - Enrolled in another interventional clinical study with therapeutic intent - Subject has known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) less than 50% of predicted normal - Subject has known moderate or severe persistent asthma within the past 2 years, or currently has uncontrolled asthma of any classification - Prior exposure to any anti-CD38 monoclonal antibody |
-Arruolamento in un altro studio di daratumumab o idoneità all'arruolamento in un altro studio clinico in corso su daratumumab. -Somministrazione di un'altra terapia anti-mieloma durante l'assunzione di daratumumab -Arruolamento in un altro studio clinico interventistico con intento terapeutico. -Presenza di COPD nota con un volume espiratorio forzato in 1 secondo (FEV1) <50% del valore normale previsto. -Storia di asma persistente moderata o grave negli ultimi due anni o asma incontrollata di qualsiasi classificazione in atto -Precedente esposizione a un qualsiasi anticorpo monoclonale anti-CD38
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Not Applicable |
Non Applicabile |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 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 | 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) | 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 | 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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 15 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 58 |
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 |
Russian Federation |
United States |
Belgium |
Italy |
Spain |
United Kingdom |
|
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
|
Enrolled subjects will be transitioned from study drug to commercial product once commercial product is available (or when daratumumab can be accessed from another source) |
I pazienti arruolati passeranno dal farmaco sperimentale al prodotto commerciale quando lo stesso sar¿ disponibile in commercio (o quando il Daratumumab sar¿ accessibile da una fonte alternativa) |
|
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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
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 |