Newly Diagnosed Myeloma patients MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Product Name: Ciclosporin
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Ciclosporin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Product N
Sponsors
FONDAZIONE NEOPLASIE SANGUE ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
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 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Age 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate event free survival and overall survival after tandem auto-allo;Secondary Objective: 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;Primary end point(s): To evaluate event free survival and overall survival after tandem auto-allo | — |
Countries
Italy
Outcome results
None listed