Multiple Myeloma MedDRA version: 18.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ZINCO SOLFATO IDI - 200 MG COMPRESSE 30 COMPRESSE
Pharmaceutical Form: Tablet
INN or Proposed INN: ZINCO SOLFATO
CAS Number: 7733-02-0
Current Sponsor code: Zinco solfato
Other descriptive
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Multiple myeloma, component M, not previously subjected to auto or allo-transplant, eligible to autologous PBSC. • Candidates for conditioning with MEL 200 (melphalan 200 mg/sqm in two doses in one day of treatment) for patients younger than 65 years, MEL 100 (melphalan 100/sqm, in two doses, one-day of therapy) for patients aged between 65 and 70 years. • Treatment with one or two prior lines of therapy, with apheresis made with high-dose cyclophosphamide and g-CSF • Aged between 18 and 70 years old, both sexes • Good general health except for the manifestations of multiple myeloma, or for frequent neurological complications related to drugs used in multiple myeloma (paresthesia, peripheral sensory neuropathy) • free diet foods fortified with zinc. • Signature of the informed consent form. 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Any contraindications to zinc or hypersensitivity to any of the excipients • Diet foods fortified with zinc • Taking supplements containing zinc or other substances, anti-oxidants • Inability to consent to participate in the study • Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Laboratory study of the immune reconstitution after auto-graft in patients treated with Zinc supplementation;Secondary Objective: Demonstration of less infectious disease, early B and T cell count recovery, higher overall-response rate in the treated arm;Primary end point(s): Advantage of thymic performance in zinc-treated group. Instruments to be used: Analysis of TRECs, flow cytometric analysis of lymphocyte subpopulations T ( Absolute values and percentages of lymphocyte populations , maturational stage of circulating lymphocytes, presence of naive lymphocytes in the peripheral blood) and Functional Test (stimulation with mitogens, superantigens and anti- CD3, dosage in the supernatant of IFN, IL- 5, IL-12 and TNF- alpha). Dosage of baseline zinchemia. The effect will be misurate also with the assay of serum thymulin (RIA);Timepoint(s) of evaluation of this end point: At the first day of stem cell collection The day of beginning of the conditioning Day +30 after stem cell infusion Day +100 after stem cell infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-lower incidence of infectious episodes in the treatment group compared to the untreated group. Tools to use: visits. A history of febrile episodes . Physical examination . Imaging tests, test cultivation and isolation by biological samples (blood cultures, cultures from sputum, detection of antigens, antibodies, specific PCR genomes of bacteria, fungi , viruses, parasites), if the patient reports suspicious incidents or presents fever. 2-potential early recovery of B lymphopoiesis and immunoglobulin production. Instruments to be used : flow cytometry on peripheral blood on B lymphocytes, determination of serum immunoglobulins 3-Greater percentage of ORR and CR and lower incidence of recurrence of disease in the treated group compared to the untreated group, regardless of the composition of the graft. Tools to use: serum protidogramma, immunofixation on urine and serum, dosage of free light – chain, assay of IgG , IgA , IgM, bone marrow biopsy, skeletal surveys (RX, MRI, PET). All of the above tests are normally inserted in the re-staging program after transplant 4-Detection of the possible side effects of treatment with zinc. Tools to use: history, physical examination, any specific diagnostic tests to be established on the basis of the symptoms reported.;Timepoint(s) of evaluation of this end point: 1-At the first day of stem cell collection The day of beginning of the conditioning Day +30 after stem cell infusion Day +100 after stem cell infusion 2-At the first day of stem cell collection The day of beginning of the conditioning Day +30 after stem cell infusion Day +100 after stem cell infusion 3-At the first day of stem cell collection The day of beginning of the conditioning Day +30 after stem cell infusion Day +100 after stem cell infusion 4-At the first day of stem cell collection The day of beginning of the conditioning Day +30 after stem cell infusion Day +100 after stem cell infusion | — |
Countries
Italy
Contacts
Public ContactSEZIONE "TMO" edificio 11
U.O. EMATOLOGIA - AOUP
Outcome results
None listed