Patients with multiple myeloma having undergone autograft MedDRA version: 12.0 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: ZOMETA
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Zoledronic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 4-
Trade Name: PR
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Patients diagnosed with multiple myeloma and having undergone a stem-cell autograft. -Adult patients aged 18 to 70 years. -Patients whose bone marrow reassessment performed at least 3 months posttransplantation shows partial remission (PR) or very good partial remission (VGPR) with measurable disease (visible monoclonal component or positive immunofixation) to rule out any late response or recurrence. -Patients having undergone an autograft, regardless of the time elapsed since stem cell re-infusion, who are in stable partial remission. -Women of childbearing potential must use a birth control method of proven efficacy during the study and must have had a negative pregnancy test (urine or serum) within 7 days prior to inclusion into the study. -ECOG performance status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with progression of disease or lack of response after autograft Serum creatinine > 3 mg/ml (265μmol/L) or creatinine clearance 12 mg/dL (3 mmol/L). Pregnancy (positive test prior to inclusion into the study) or breastfeeding.Women of childbearing potential not using an appropriate birth control method. Patients considered by the investigator to be incapable of collaborating during the study Hypersensitivity to Zoledronic Acid or other bisphophonates. Hypersensitivity to IL-2. Patients with significant history or evidence of severe ongoing cardiopathy. Patients with evidence of ongoing infection requiring antibiotic therapy. Patients with bilirubin levels out of normal range. Patients with known, pre-existing auto-immune disease. Patients on cortisone therapy for other diseases. Presence of other diseases that in the opinion of the investigator might affect participation in the study Treatment with an investigational drug during the 30 days preceding the start of the study. Bone-related disorders (eg, Paget`s Disease)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Time to progression;Secondary Objective: Time to second-line treatment.Time to second graft.Safety and tolerability of IL-2 and zoledronic acid.;Primary end point(s): Laboratory or instrumental signs of disease progression (increase in monoclonal component, progression of bone lesions, the occurrence or progression of renal insufficiency) represent the endpoint of the study and determine the suspension of the study and use of appropriate therapies | — |
Countries
Italy
Outcome results
None listed