Hodgkin Disease, Multiple Myeloma, Non-Hodgkin Lymphoma
Conditions
Brief summary
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.
Interventions
DRUGTG-0054 (2.24 mg/kg)
TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
DRUGTG-0054 (3.14 mg/kg)
TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
Sponsors
GPCR Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female 18 to 70 years of age inclusive * Patients with confirmed pathology diagnosis of MM, NHL or HD * Potential candidate for autologous stem cell transplantation at Investigator's discretion * ≦ 2 prior regimens of cytotoxic chemotherapy (rituximab, thalidomide, and bortezomib will not be considered as cytotoxic chemotherapy) * \> 4 weeks since last cycle of chemotherapy prior to the study drug administration * Total dose of melphalan received ≦ 200 mg in the most recent chemotherapy treatment * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Recovered from all acute toxic effects of prior chemotherapy at Investigator's discretion * White blood cell (WBC) count ≧ 3.0 x 109/L on screening laboratory assessments * Absolute neutrophil count ≧ 1.5 x 109/L on screening laboratory assessments * Platelet count ≧ 100 x 109/L on screening laboratory assessments * Serum creatinine ≦ 2.2 mg/dL on screening laboratory assessments * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubin \< 2 x upper limit of normal (ULN) on screening laboratory assessments * Negative for human immunodeficiency virus (HIV) * Adequate cardiac and pulmonary function to undergo leukapheresis at Investigator's discretion * For females, one of the following criteria must be fulfilled: 1. At least one year post-menopausal, or 2. Surgically sterile, or 3. Willing to use a double-barrier method \[intrauterine device (IUD) plus condom, spermicidal gel plus condom\] of contraception throughout the study * Males must be willing to use a reliable form of contraception (use of a condom or a partner fulfilling the above criteria) from study Day 1 until 28 days after the last dose of TG-0054 * Able to provide the signed informed consent
Exclusion criteria
* Received radiation therapy around the pelvic or spinal area within 6 months prior to the study drug administration * \>10% bone marrow involvement of lymphoma in NHL patients * Failed previous stem cell collection \[failed to collect 2 x 106 CD34+ cells/kg within 4 apheresis sessions after receiving granulocyte colony-stimulating factor (G-CSF)\] * Patients who have undergone previous stem cell transplantation procedure * Received G-CSF within 2 weeks prior to the study drug administration * History of other cancer within the past 5 years excluding MM, NHL, HD, basal cell or squamous cell carcinoma of the skin * History of other hematologic disorders including bleeding or thromboembolic disease * History of poor and uncontrollable cardiovascular or pulmonary disease such as myocardial infarction, cardiac arrhythmias, transient ischemic attack, stroke or Chronic Obstructive Pulmonary Disease (COPD) patients hospitalized more than two times a year due to underlying disease * Diagnosis of sickle cell anemia or documented sickle cell trait * Uncontrollable malignancy with MM, NHL or HD, or carcinomatous meningitis, at Investigator's discretion * Any infection required antibiotic treatment or unexplained fever above 38 °C within 3 days prior to dosing * Pregnant or breast-feeding * Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study * Received any other investigational drug within 1 month before entering the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 1 week | Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. | 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. | 36 hrs after infusion | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 36 hrs after infusion | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 36 hrs after infusion | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| 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. | 36 hrs after infusion | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 36 hrs after infusion | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 36 hrs after infusion | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 36 hrs after infusion | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 36 hrs after infusion | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
| Circulating CD34+ Cell Counts in Peripheral Blood. | Baseline, 3 hours and 6 hours 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. | 36 hrs after infusion | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. |
Countries
Taiwan
Participant flow
Pre-assignment details
A total of 20 subjects were randomized. Among these, 19 subjects met all eligibility criteria and received at least one dose of TG-0054.
Participants by arm
| Arm | Count |
|---|---|
| TG-0054 (2.24 mg/kg) TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) | 7 |
| TG-0054 (3.14 mg/kg) TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) | 12 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Not received at least one dose | 0 | 1 |
| Overall Study | Peak CD34+ cell count in PB < 10 cell/uL | 3 | 9 |
Baseline characteristics
| Characteristic | TG-0054 (3.14 mg/kg) | Total | TG-0054 (2.24 mg/kg) |
|---|---|---|---|
| Age, Continuous | 52.4 years STANDARD_DEVIATION 9.3 | 50.5 years STANDARD_DEVIATION 11.8 | 47.3 years STANDARD_DEVIATION 15.5 |
| Body Mass Index | 24.0 kilogram/ meter^2 STANDARD_DEVIATION 3 | 24.4 kilogram/ meter^2 STANDARD_DEVIATION 4.2 | 25.1 kilogram/ meter^2 STANDARD_DEVIATION 6 |
| Diagnosis Hodgkin disease | 1 participants | 2 participants | 1 participants |
| Diagnosis Multiple myeloma | 4 participants | 7 participants | 3 participants |
| Diagnosis Non-Hodgkin lymphoma | 7 participants | 10 participants | 3 participants |
| Height | 158.7 centimeters STANDARD_DEVIATION 8.6 | 160.2 centimeters STANDARD_DEVIATION 9.1 | 162.7 centimeters STANDARD_DEVIATION 10.1 |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 4 Participants |
| Sex: Female, Male Male | 5 Participants | 8 Participants | 3 Participants |
| Weight | 60.6 kilogram STANDARD_DEVIATION 10.2 | 63.1 kilogram STANDARD_DEVIATION 15.9 | 67.3 kilogram STANDARD_DEVIATION 23.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 7 | 8 / 12 |
| serious Total, serious adverse events | 2 / 7 | 6 / 12 |
Outcome results
Primary
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
Population: In TG-0054 (2.24 mg/kg) group, A total of 4 patients (2 with MM, 1 with NHL, and 1 with HD) underwent apheresis procedure.~In TG-0054 (3.14 mg/kg) group, A total of 3 patients (1 with MM and 2 with NHL) underwent apheresis procedure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| TG-0054 (2.24 mg/kg) | 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). | MM | 1 participants |
| TG-0054 (2.24 mg/kg) | 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). | NHL | 1 participants |
| TG-0054 (2.24 mg/kg) | 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). | HD | 0 participants |
| TG-0054 (3.14 mg/kg) | 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). | MM | 1 participants |
| TG-0054 (3.14 mg/kg) | 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). | NHL | 0 participants |
| TG-0054 (3.14 mg/kg) | 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). | HD | 0 participants |
Secondary
Circulating CD34+ Cell Counts in Peripheral Blood.
Time frame: Baseline, 3 hours and 6 hours after infusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TG-0054 (2.24 mg/kg) | Circulating CD34+ Cell Counts in Peripheral Blood. | PB CD34+ count (3 hours after infusion) | 5.7 cells/μL | Standard Deviation 4 |
| TG-0054 (2.24 mg/kg) | Circulating CD34+ Cell Counts in Peripheral Blood. | PB CD34+ count (6 hours after infusion) | 6.3 cells/μL | Standard Deviation 3.9 |
| TG-0054 (2.24 mg/kg) | Circulating CD34+ Cell Counts in Peripheral Blood. | PB CD34+ count (Baseline) | 1.0 cells/μL | Standard Deviation 0.7 |
| TG-0054 (2.24 mg/kg) | Circulating CD34+ Cell Counts in Peripheral Blood. | PB CD34+ count (Maximum increase) | 7.8 cells/μL | Standard Deviation 4.4 |
| TG-0054 (3.14 mg/kg) | Circulating CD34+ Cell Counts in Peripheral Blood. | PB CD34+ count (3 hours after infusion) | 4.0 cells/μL | Standard Deviation 2.1 |
| TG-0054 (3.14 mg/kg) | Circulating CD34+ Cell Counts in Peripheral Blood. | PB CD34+ count (Baseline) | 0.9 cells/μL | Standard Deviation 0.5 |
| TG-0054 (3.14 mg/kg) | Circulating CD34+ Cell Counts in Peripheral Blood. | PB CD34+ count (6 hours after infusion) | 4.3 cells/μL | Standard Deviation 2.7 |
| TG-0054 (3.14 mg/kg) | Circulating CD34+ Cell Counts in Peripheral Blood. | PB CD34+ count (Maximum increase) | 5.2 cells/μL | Standard Deviation 3.7 |
| All Patients | Circulating CD34+ Cell Counts in Peripheral Blood. | PB CD34+ count (6 hours after infusion) | 5.1 cells/μL | Standard Deviation 3.3 |
| All Patients | Circulating CD34+ Cell Counts in Peripheral Blood. | PB CD34+ count (Baseline) | 1.0 cells/μL | Standard Deviation 0.6 |
| All Patients | Circulating CD34+ Cell Counts in Peripheral Blood. | PB CD34+ count (3 hours after infusion) | 4.6 cells/μL | Standard Deviation 2.9 |
| All Patients | Circulating CD34+ Cell Counts in Peripheral Blood. | PB CD34+ count (Maximum increase) | 6.5 cells/μL | Standard Deviation 4.1 |
Secondary
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
Population: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TG-0054 (2.24 mg/kg) | Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 52.5 mL/ hr/kg | Standard Deviation 9.4 |
| TG-0054 (3.14 mg/kg) | Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 58.6 mL/ hr/kg | Standard Deviation 13 |
Secondary
Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.
Time frame: Baseline, 3 hours and 6 hours after infusion
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TG-0054 (2.24 mg/kg) | Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. | Fold increase (6 hours after infusion) | 7.8 fold | Standard Deviation 7.2 |
| TG-0054 (2.24 mg/kg) | Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. | Fold increase (3 hours after infusion) | 7.0 fold | Standard Deviation 5.9 |
| TG-0054 (2.24 mg/kg) | Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. | Fold increase (Maximum increase) | 9.3 fold | Standard Deviation 7.5 |
| TG-0054 (3.14 mg/kg) | Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. | Fold increase (6 hours after infusion) | 7.8 fold | Standard Deviation 10.4 |
| TG-0054 (3.14 mg/kg) | Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. | Fold increase (3 hours after infusion) | 6.1 fold | Standard Deviation 6.1 |
| TG-0054 (3.14 mg/kg) | Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. | Fold increase (Maximum increase) | 10.3 fold | Standard Deviation 8.9 |
| All Patients | Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. | Fold increase (3 hours after infusion) | 6.4 fold | Standard Deviation 5.9 |
| All Patients | Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. | Fold increase (Maximum increase) | 10.0 fold | Standard Deviation 8.4 |
| All Patients | Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. | Fold increase (6 hours after infusion) | 7.8 fold | Standard Deviation 9.1 |
Comparison: Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.p-value: 0.023t-test, 2 sided
Comparison: Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.p-value: 0.038t-test, 2 sided
Secondary
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
Population: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TG-0054 (2.24 mg/kg) | Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 20971 ng/mL | Standard Deviation 6995 |
| TG-0054 (3.14 mg/kg) | Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 29665 ng/mL | Standard Deviation 18583 |
Secondary
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
Population: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TG-0054 (2.24 mg/kg) | Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 4.65 hr | Standard Deviation 0.4 |
| TG-0054 (3.14 mg/kg) | Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 4.28 hr | Standard Deviation 0.6 |
Secondary
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
Population: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TG-0054 (2.24 mg/kg) | Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 0.15 1/hr | Standard Deviation 0.01 |
| TG-0054 (3.14 mg/kg) | Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 0.16 1/hr | Standard Deviation 0.02 |
Secondary
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
Population: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TG-0054 (2.24 mg/kg) | 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. | 43713 hr*ng/mL | Standard Deviation 7039 |
| TG-0054 (3.14 mg/kg) | 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. | 55920 hr*ng/mL | Standard Deviation 12170 |
Secondary
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.
Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
Time frame: 36 hrs after infusion
Population: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TG-0054 (2.24 mg/kg) | 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. | 43610 hr*ng/mL | Standard Deviation 7034 |
| TG-0054 (3.14 mg/kg) | 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. | 55814 hr*ng/mL | Standard Deviation 12153 |
Secondary
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
Population: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TG-0054 (2.24 mg/kg) | Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 0.25 hr | Standard Deviation 0 |
| TG-0054 (3.14 mg/kg) | Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 0.25 hr | Standard Deviation 0 |
Secondary
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
Population: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TG-0054 (2.24 mg/kg) | Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 179 mL/kg | Standard Deviation 64 |
| TG-0054 (3.14 mg/kg) | Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 193 mL/kg | Standard Deviation 76 |
Secondary
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
Population: According to the protocol, blood samples for PK assessment of TG-0054 were obtained from 6 consenting patients in each arm on study Day 1 at pre-dose, end of infusion, and 1 hr, 3 hr, 6 hr, 9 hr, 12 hr, 24 hr and 36 hrs after infusion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TG-0054 (2.24 mg/kg) | Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 351 mL/kg | Standard Deviation 62 |
| TG-0054 (3.14 mg/kg) | Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD. | 366 mL/kg | Standard Deviation 112 |