patients affected by multiple myeloma requiring chemotherapy with high-dose melphalan (100 mg/m2). MedDRA version: 9.1 Level: LLT Classification code 10028228 Term: Multiple myeloma
Conditions
Interventions
Trade Name: JANUVIA
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: SITAGLIPTIN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Sponsors
AZIENDA OSPEDALIERA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. age > 65 years 2. occurrence of multiple myeloma requiring treatment with high-dose melphalan (100 mg/m2) and autologous hematopoietic stem cell rescue 3. lack of diabetes mellitus requiring treatment with other antidiabetes drugs 4. patients must be able to understand and behave as requested by study protocol, ad must sign 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) no 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
Exclusion criteria: 1. concurrent use of other antidiabetes drug of any category. 2. previous hypoglycemic events and contemporary drug administration that can accentuate treatment hypoglycemic events 3. previous allergic reactions or hypersensitivity status against sitagliptin or other excipients of Januvia 3. poor compliance with previous treatments
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy of sitagliptin at reducing the number of platelet concentrates during the autotransplantation procedure.;Secondary Objective: Evaluation of the efficacy of sitagliptin at modulating serum CXCL12 levels, reducing days of staying at hospital, reducing the costs-per-patient, and reducing infective episodes. - Evaluation of safety and tolerability;Primary end point(s): variation of serum concentration of the chemokine CXCL12 | — |
Countries
Italy
Outcome results
None listed