A phase II study to evaluate the safety, pharmacokinetics, and hematopoietic stem cell mobilization of TG-0054 in patients with multiple myeloma, non-Hodgkin lymphoma or Hodgkin disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
Chang-Gung Memorial Hospital Chiayi
Chiayi City, Taiwan
Buddist Tzu Chi General Hospital
Hualien City, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Chang-Gung Memorial Hospital Linkou
Linkou District, Taiwan
Number of Patients Who Achieved Mobilization Success of Hematopoietic Stem Cells in Patients With Multiple Myeloma (MM), Non-Hodgkin Lymphoma (NHL) or Hodgkin Disease (HD).
Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success.
Time frame: 1 week
Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Time frame: 36 hrs after infusion
Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.
Time frame: Baseline, 3 hours and 6 hours after infusion
Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Time frame: 36 hrs after infusion
Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Time frame: 36 hrs after infusion
Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Time frame: 36 hrs after infusion
The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Time t of TG-0054 in 12 Consented Patients With MM, NHL or HD.
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National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Time frame: 36 hrs after infusion
The Area Under the Plasma Concentration Time Curve (AUC) From 0 Hours to Infinity of TG-0054 in 12 Consented Patients With MM, NHL or HD.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Time frame: 36 hrs after infusion
Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Time frame: 36 hrs after infusion
Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Time frame: 36 hrs after infusion
Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Time frame: 36 hrs after infusion
Circulating CD34+ Cell Counts in Peripheral Blood.
Time frame: Baseline, 3 hours and 6 hours after infusion