Immunologic system stimulation as maintaining therapy in hematological cancer

Conditions: Multiple Myeloma patients underwent to autologous bone marrow transplant
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2013-001188-22-IT

Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Multiple Myeloma patients underwent to autologous bone marrow transplant, Patients between 18 and 70 yrs, Patients evaluated three months later the bone marrow transplant and in VGPR with measurable disease ( M protein or immunofixation presence) ECOG performance status < 2, Written consent before any procedure

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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

Not responder patients after autologous bone marrow transplant, renal impairment as creatinine level > 3 mg/ml (265µmol/L) or clearance < 30 ml/min active dental disease, previous story or planned oral surgery (within 6 weeks), Abnormal serum calcium levels < 8.0 mg/dL (2 mmol/L) o > 12 mg/dL (3 mmol/L), Pregnancy or absence of pregnancy prevention (for women in reproduction age), Psychiatric disease, Liver disease, Cardiopathy, Active infection, Disease of autoimmunity, Bone pathology, Other recent (within 30 days) treatment in clinical investigation study, Bone disease (ie. Paget), Adverse reaction to zolendronic acid and/or interleukin -2

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Time to progression;Secondary Objective: Time to retreatment, safety and tolerability of IL-2 and zolendronic acid;Primary end point(s): Clinical and laboratoristic progression of disease (onset or increase of monoclonal component, increased beta-2 microglobulin in two consecutive quarterly checks, progression of bone lesions, onset or progression of renal insufficiency).;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): For the secondary endpoints are to be considered an increase of 50% of the monoclonal component in two months, onset or progression of bone lesions, onset or progression of renal insufficiency and anemia. These parameters will determine the suspension of the study and the use of adequate therapies (chemotherapy or second autotransplantation if indicated), in accordance with the criteria of the International Myeloma Working Group (IMWG).<br>Safety and tolerability. Safety assessments will be based on the recording of all adverse events and serious adverse events, the general physical condition. The severity of adverse events will be determined according to the NCI CTC (National Cancer Institute - Common Toxicity Criteria). Disease progression is not considered a serious adverse event, even if it meets the criteria for defining;Timepoint(s) of evaluation of this end point: See information about the secondary endpoints above.