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

Active, not recruiting

• Conditions: Patients with multiple myeloma having undergone autograft; MedDRA version: 12.0Level: LLTClassification code 10028228Term: Multiple myeloma

• Registration Number: EUCTR2009-012583-13-IT
• Lead Sponsor: AZIENDA OSPEDALIERA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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 <= 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

Exclusion Criteria

Patients with progression of disease or lack of response after autograft Serum creatinine > 3 mg/ml (265&#956;mol/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)

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 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