E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with multiple myeloma having undergone autograft |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10028228 |
E.1.2 | Term | Multiple myeloma |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
|
E.2.2 | Secondary objectives of the trial |
Time to second-line treatment.Time to second graft.Safety and tolerability of IL-2 and zoledronic acid. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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) |
|
E.5 End points |
E.5.1 | 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 |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |