Phase II study of interleukin-2 and zoledronic acid as maintenance therapy in patients with multiple myeloma having undergone autograft - ND

AZIENDA OSPEDALIERA PISANA0 sitesStarted: September 18, 2009Last updated: March 19, 2012

Conditions

Drugs

Trial Snapshot

No summary available.

•-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 <= 2. -Written informed consent signed prior to performing any study-related 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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Patients with progression of disease or lack of response after autograft Serum creatinine > 3 mg/ml (265μmol/L) or creatinine clearance < 30 ml/min, calculated as per Cockcroft-Gault formula Ongoing dental diseases including infections of teeth, maxilla or jaw bone; dental or implant trauma, diagnosis of maxillary or mandibular osteonecrosis or exposed bone, Recent (within 6 weeks) or planned dental or maxillary or mandibular surgery (eg, extractions, implants). Corrected serum calcium (adjusted based on serum albumin) < 8.0 mg/dL (2 mmol/L) o > 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)

Sponsor

AZIENDA OSPEDALIERA PISANA