Summary
A randomized phase II study for evaluation of T cell depleted non-myeloablative allogeneic stem cell transplantation followed by early consolidation with lenalidomide or lenalidomide combined with bortezomib and subsequent DLI for patients with multiple myeloma in progression or relapse following first line therapy
Inclusion criteria
- Patients with multiple myeloma with a first relapse after first line therapy;
- Relapsed patients have received reinduction therapy before entering this trial;
- At least a PR after reinduction treatment
- 18-65 years, inclusive;
- HLA- identical sibling or unrelated donor completely matched (10/10)
- WHO-performance status 0-2;
- Written informed consent.
Exclusion criteria
- Previous Allo-SCT;
- Severe pulmonary dysfunction (CTCAE grade III-IV, see appendix D);
- Severe neurological or psychiatric disease;
- Patients with neuropathy, CTC grade 3 or higher;
- Significant hepatic dysfunction (serum bilirubin or transaminases ≥ 3 times upper limit of normal);
- Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, cancer, etc.);
- History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or or carcinoma “in situ” of the cervix or breast;
- Patient known to be HIV-positive;
- Patients with brain disease with the exception of those patients whose brain disease has been treated with either radiotherapy or surgery and remains asymptomatic, with no active brain disease, as shown by CT scan or MRI, for at least 6 months;
- The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide, lenalidomide or borium;
- Pregnant or breast-feeding female patients. Negative pregnancy test at study is mandatory for female patients of childbearing potential,
- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
- Severe cardiac dysfunction (NYHA classification II-IV, see appendix E).