Prospective, phase II study to evaluate the efficacy and the safety of a combination of bendamustine-melphalan as preparative regimen to autologous transplantation of hematopoietic cells for multiple myeloma who have relapsed after previous high-dose therapy

FONDAZIONE NEOPLASIE SANGUE ONLUS (FO.NE.SA. Onlus)0 sites73 target enrollmentFebruary 6, 2014

Overview

No summary available.

Registry

who.int

Start Date

February 6, 2014

End Date

TBD

Last Updated

8 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

FONDAZIONE NEOPLASIE SANGUE ONLUS (FO.NE.SA. Onlus)

•Age \= 18 \= 70 years.
•Multiple myeloma patients who have relapsed after first\-line therapy including ASCT (single or tandem) with an interval between the last ASCT and clinical relapse of at least 12 months.
•At least stable disease after \= 4\-6 cycles of salvage treatment (see specific chapter in the protocol)
•Performance of patient screening between 30 and 90 days after the end of salvage treatment
•Measurable myeloma defined by M\-protein \> 1000 mg/dL if IgG or 500 mg/dL if IgA or Bence Jones protein \> 200 mg/24 h or free light chain \> 100 mg/L or measurable extramedullary plasmacytoma \> 2 cm at the time of relapse and before the beginning of salvage treatment.
•Collection of at least 3 x 106/Kg autologous hematopoietic stem cell (harvested at any time)
•HCT\-CI \= 5
•Adequate cardiac function with left ventricular ejection fraction \= 50%.
•Adequate renal function with Clearance creatinine \= 50 ml/min
•Adequate hepatic function with serum bilirubin \<1,5 mg/L and AST and ALT values \< 100 UI/L.

•Early relapse defined by an interval between the last ASCT and clinical relapse requiring salvage treatment \< 12 months.
•Progression after \= 3 cycles of salvage treatment.
•Plasma cell leukaemia.
•SNC myeloma localization.
•Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
•Any active infection (e.g. failure to resolve previous infections or new infections)
•Pregnant or breast feeding females.
•Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.
•Positive serologic markers for human immunodeficiency virus (HIV).
•Acute hepatitis B virus (HBV) with positive HBsAg and/or HBV\-DNA. Patients having negative HBV\-DNA, but with HBcAb positive serology, will not be excluded from the study and be given Lamivudine (100 mg /die) as prophylaxis starting one week before chemotherapy. HbsAg and AST/ALT and HBVDNA will be monitored every three weeks. Lamivudine therapy should be continued for one year after the end of therapy.