Multiple myeloma
Conditions
Interventions
Trade Name: Levact®
Product Name: Levact ® i.v.
Product Code: Not applicable
Pharmaceutical Form: Powder and solution for solution for injection
Sponsors
FONDAZIONE NEOPLASIE SANGUE ONLUS (FO.NE.SA. Onlus)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 30% and/or no need of supplementary oxygen. • Able to adhere to the study visit schedule and other protocol requirement. • Disease free of prior malignancies for at least 2 years. • Women of child bearing potential and male patients whose partner is a woman of child bearing potential must be prepared to use effective methods of contraception both before and during protocol treatment, or commit to absolute and continuous abstinence. Men must not father a child for up to 6 months following cessation of treatment and must use condoms. • Written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: • 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. • Acute hepatitis C virus (HCV) infection with positive HCV-RNA. • Major surgery less than 30 days before start of treatment. • Patients not agreeing to take adequate contraceptive measures during the study. • Any active, uncontrolled infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: Not applicable;Primary end point(s): • Rate of new VGPR+CR on day + 100 after transplant in comparison with pre-transplant evaluation • Toxicity rate evaluated as proportion of patients developing at least one event of grade 3 and 4 extrahematological toxicity ;Timepoint(s) of evaluation of this end point: +100 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Engraftment • Transplant-related.-mortality (TRM) • Rate of grade 3 and 4 mucositis • Rate of cumulative VGPR + CR on day +100 (after salvage treatment and after transplant) • Progression-free survival • Overall survival ;Timepoint(s) of evaluation of this end point: 3 years | — |
Countries
Italy
Contacts
Public ContactUfficio Sperimentazioni Cliniche
FONDAZIONE NEOPLASIE SANGUE ONLUS (FO.NE.SA. Onlus)
Outcome results
None listed