multiple myeloma MedDRA version: 14.1 Level: PT Classification code 10028228 Term: Multiple myeloma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Mozobil
Pharmaceutical Form: Solution for injection
INN or Proposed INN: PLERIXAFOR
CAS Number: 110078-46-1
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg/ml mi
Sponsors
AZIENDA OSPEDALIERA DI BOLOGNA POLICLINICO S. ORSOLA M. MALPIGHI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • MM patients eligible and planned for ASCT according to Istitutional guidelines • Age > 18 years • Written informed consent • Performance Status = 70% (Karnofsky) or = 2 (WHO). • White blood cell (WBC) count = 2.5 x 109 /L • Absolute neutrophil count (ANC) = 1.5 x 109 /L • Platelet count = 100 x 109 /L • Serum creatinine at time of enrollment = 2.0 mg/dL • Aspartate aminotransferase/serum glutamnic oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamnic pyruvic transaminase (ALT/SGPT), and total bilirubin at time of enrollment =65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: • History of any acute or chronic myelogenous leukemia • HIV positivity; active Hepatitis B or Hepatitis C • Intercurrent organ damage or medical problems that would interfere with therapy. • Pregnant or nursing females. • Concurrent uncontrolled infection. • Previously received investigation therapy within 4 weeks of enrolling in this protocol or currently enrolled in another investigational protocol during the mobilization phase • Treated with G-CSF or other cytokine within 14 days prior to the first dose of G-CSF for mobilization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?Percentage of patients collecting = 6 x 106 CD34+ cells/Kg in three or less apheresis;Secondary Objective: ?Number of apheresis to collect = 6 x 106 CD34+ cells/Kg ?Evaluation of engraftment after transplantation of plerixafor-mobilized PBSCs ?Evaluation of immunological reconstitution after transplantation ?Evaluation of cellular graft content ?Evaluation of resources consumption and relative direct costs estimation in the management of patients with plerixafor therapy in association with G-CSF after chemotherapy ?Percentage of patients collecting = 4 x 106 CD34+ cells/Kg in three or less apheresis following rescue strategy (plerixafor + G-CSF), and number of apheresis required;Primary end point(s): ?Number of CD34+ cells mobilized into PB ?Number of PBSC collections;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Number of days to neutrophil and platelet engraftment. ? Kinetic of immunological reconstitution as the number of circulating lymphocytes, CD3+ , CD4+, CD8+, CD19+ , T-reg and CD56+ cells at 30 days, 3,6,9 and 12 months after transplantation. ? Concentration of stem cell and lymphocyte subsets into leukaphereses. ? Type and quantity of medical resources and estimation of relative direct medical costs for plerixafor therapy in association with G-CSF after chemotherapy.;Timepoint(s) of evaluation of this end point: 12 months | — |
Countries
Italy
Contacts
Public ContactU.O. Ematologia-PI Prof. Lemoli
AOU di Bologna Policlinico S.Orsola-Malpighi
Outcome results
None listed