Phase II clinic trial for the reduction of time of hematopoietic stem cell engraftment with sitagliptin in patients with multiple myeloma receiving autologous transplantation - ND
- Conditions
- patients affected by multiple myeloma requiring chemotherapy with high-dose melphalan (100 mg/m2).MedDRA version: 9.1Level: LLTClassification code 10028228Term: Multiple myeloma
- Registration Number
- EUCTR2008-005042-23-IT
- Lead Sponsor
- AZIENDA OSPEDALIERA PISANA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method