Multiple Myeloma patients underwent to autologous bone marrow transplant
Conditions
Interventions
Trade Name: ZOMETA
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: zoledronic acid
CAS Number: 165800-06-6
Other descriptive name: ZOLEDRONIC ACID MONOHYDRATE
C
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: Not responder patients after autologous bone marrow transplant, renal impairment as creatinine level > 3 mg/ml (265µmol/L) or clearance 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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). 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. | — |
Countries
Italy
Contacts
Public ContactU.O. EMATOLOGIA
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Outcome results
None listed