E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Newly Diagnosed Myeloma patients |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028228 |
E.1.2 | Term | Multiple myeloma |
|
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 |
To evaluate event free survival and overall survival after tandem auto-allo |
|
E.2.2 | Secondary objectives of the trial |
As all new drugs have immunomodulatory properties, secondary aims of the study will be: 1. To evaluate transplant related mortality 2. To evaluate incidence of major infections and grade 2-4 GVHD 3. To evaluate the role of prognostic factors including cytogenetic abnormalities |
|
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Confirmed diagnosis of symptomatic MM based on standard criteria (including cytogenetic prognostic markers) 2. The patient must have the capacity to give informed consent. 3. Age >18 and < 65 4. Previous enrollment on protocol MM-BO2005 or RV-MM-PI-209 or have received at least 3 courses of induction therapy including either thalidomide, lenalidomide or bortezomib alone or in combination. 5. If female, the patient is either postmenopausal since at least 24 consecutive months or surgically sterilized or she agrees to practice sexual abstinence or to use two reliable methods for contraception (e.g. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide) for the duration of study 6. If male, the patient agrees to practice sexual abstinence or to use a latex condom during any sexual contact with women of childbearing potential for the duration of study 7. Negative pregnancy test 1. Eta' <18 e >65 anni 2. Karnofsky score inferiore a 60 (vedi appendice C ) , eccetto quello dovuto al Mieloma 3. Frazione di eiezione ventricolare sinistra inferiore al 40%, o coronaropatia sintomatica o altre insufficienze cardiache che richiedono una terapia. 4. Bilirubina 2 volte il limite normale o SCPT e SCROT 4 volte il limite normale. 5. DLCO < 40% (corretta) o necessita' di ricevere ossigenoterapia continua. 6. Pazienti con ipertensione mal controllata. 7. Pazienti con tumori non ematologici attivi (eccetto tumori cutanei diversi dal melanoma). 8. Pazienti con pregressi tumori non-ematologici (eccetto tumori cutanei diversi dal melanoma) in remissione completa da meno di 5 anni o con rischio di recidiva superiore al 20%. 9. Gravidanza. 10. Sieropositivita' al virus del HIV. 11. Uomini o donne fertili che rifiutano di usare metodi contraccettivi durante il trattamento e per i dodici mesi successivi. 12. Clearance Creatinina < 40 cc/min al momento della valutazione dellautotrapianto |
|
E.4 | Principal exclusion criteria |
1. Age <18 and >65 2. Karnofsky score less than 60 (see appendix C), unless due solely to myeloma 3. Left ventricular ejection fraction less than 40%, or symptomatic coronary artery disease or other cardiac failure requiring therapy 4. Bilirubin greater than 2 X the upper limit of normal, or SGPT and SGOT > 4 X the upper limit of normal 5. DLCO < 40% (corrected) or receiving continuous supplemental oxygen. 6. Patients with poorly controlled hypertension 7. Patients with active non-hematologic malignancies (except non-melanoma skin cancers). 8. Patients with a history of non-hematologic malignancies (except non-melanoma skin cancers) currently in a complete remission, who are less than 5 years from the time of complete remission, and have a >20% risk of disease recurrence 9. Pregnancy 10. Seropositive for the human immunodeficiency virus 11. Fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment. 12. Creatinine clearance < 40 cc/min at the time of initial autografting evaluation. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate event free survival and overall survival after tandem auto-allo |
|
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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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.8.3 |
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.8.5 | 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 | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
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
| |
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 | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |