E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Multiple Myeloma in maintenance treatment with Lenalidomide |
Pazienti affetti da Mieloma Multiplo in mantenimento con Lenalidomide |
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E.1.1.1 | Medical condition in easily understood language |
Patients with Multiple Myeloma in maintenance treatment with Lenalidomide |
Pazienti affetti da Mieloma Multiplo in mantenimento con Lenalidomide |
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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 | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10028229 |
E.1.2 | Term | Multiple myelomas |
E.1.2 | System Organ Class | 100000004851 |
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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 |
1.To evaluate the activity of Lenalidomide on tumour load during maintenance phase analysing; 2.To verify whether molecular remissions obtained during maintenance therapy with Lenalidomide-based regimen are associated with a prolonged PFS. |
1. Valutazione dell'attività di Lenalidomide del carico tumorale durante la fase di mantenimento 2. Verificare quando la remissione molecolare ottenuta durante la terapia di mantenimento con Lenalidomide è associata ad un prolumgamento della progressione libera da malattia |
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E.2.2 | Secondary objectives of the trial |
1. To verify whether MRD negativity obtained with Lenalidomide-based regimen maintenance is transient or persistent; 2. To verify whether molecular relapse always anticipates clinical relapse (MRD as early biomarker of relapse); 3. To investigate the role of MRD monitoring in peripheral blood compared with bone marrow; 4. To determine whether molecular remission is associated with longer Overall Survival. |
1. Verificare se MRD negativa ottenuta in seguito a trattemento di mantenimento con Lenalidomide è transitoria o persistente; 2. Verificare se la remissione molecolare anticipa sempre la remissione clinica; 3. Valutare il ruolo del monitoraggio della MRD in sangue periferico comparato con midollo osseo 4. Determinare quando la remissione molecolare è associata a un prolungamento della sopravvivenza libera da malattia. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Patient has achieved at least a Very Good Partial Response before starting maintenance treatment
- Availability of a bone marrow sample at diagnosed stored in the institution tissue bank to create patient-specific probes derived from IgH rearrangement |
- Paziente che ha raggiunto una Very Good Partial Response prima dell'inzio della terapia di mantenimento
- Disponibilità di un campione di midollo osseo del paziente alla diagnosi presso la banca dell'istituto per creare prove paziente-specifiche derivanti da riarrangiamento IgH |
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E.4 | Principal exclusion criteria |
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E.5 End points |
E.5.1 | Primary end point(s) |
1.Rate of conversion from MRD positive to MRD negative during maintenance therapy; 2.Rate of patients with a reducing or increasing tumour load during therapy; 3.Rate of molecular relapse. |
1. tasso di conversione da MRD positivo a MRD negativo durante la terapia di mantenimento
2. tasso di pazienti con riduzione o aumento del carico tumorale durante la terapia
3. Tasso di remission molecolare wheter MRD negativity obtained with lenalidomide-based regimen maintence is transient or persistent;
2 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. To verify wheter MRD negativity obtained with Lenalidomide-based regimen maintenance is transient or persistent
2. To verify wheter molecular relapse always anticipates clinical relapse (MRD as early biomarker of relapse)
3. To investigate the role of MRD monitoring in peripheral blood compared with bone marrow
4. To determine wheter molecular remmission is associated with longer OS |
1. Verificare quando la negatività MRD ottenuta grazie a un regime di trattamento con lenalidomide è transitoria o persistente
2. Verificare se la ricaduta molecolare anticipa sempre la recidiva clinica (MRD come bio-indicatore precoce di recidiva)
3. Per studiare il ruolo del monitoraggio MRD nel sangue periferico rispetto al midollo osseo
4. Per determinare se la remissione molecolare è associato a un prolungamento dell'OS |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | No |
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 |
Minimal residual disease monitoring |
Monitoraggio malattia minima residua |
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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 | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |