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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TG-0054 (2.24 mg/kg) | Experimental | 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) | Experimental | TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TG-0054 (2.24 mg/kg) | Drug | TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 36 hrs after infusion |
| Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. |
Not provided
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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Tzeon-Jye Chiou, MD | Taipei Veterans General Hospital, Taiwan | Principal Investigator |
| Tso-Fu Wang, MD | Buddist Tzu Chi General Hospital | Principal Investigator |
| Sheng-Fung Lin, MD | Kaohsiung Medical University | Principal Investigator |
| Chih-Cheng Chen, MD | Chang Gung Memorial Hospital, Chiayi | Principal Investigator |
| Po-Nan Wang, MD | Chang Gung Memorial Hospital | Principal Investigator |
| Jih-Luh Tang, MD | National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang-Gung Memorial Hospital Chiayi | Chiayi City | Taiwan | ||||
| Buddist Tzu Chi General Hospital |
A total of 20 subjects were randomized. Among these, 19 subjects met all eligibility criteria and received at least one dose of TG-0054.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
19 subjects met all eligibility criteria and received at least one dose of TG-0054.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | 1 week |
|
The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)
There were 8 serious AEs (SAE) reported that were all unrelated to study drug. No AEs led to discontinuation of study drug treatment and there were no deaths reported in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ADMISSION FOR PREPARATION OF PERIPHERAL BLOOD STEM CELL HARVEST | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment | Post-treatment SAE. Definitely not related to study drug |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Probably related to study drug. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chen-En Tsai, M.D., Ph.D. | TaiGen Biotechnology Co., Ltd. | +886-2-8177-7072 | 1211 | cetsai@taigenbiotech.com |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D008228 | Lymphoma, Non-Hodgkin |
| D006689 | Hodgkin Disease |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| TG-0054 (3.14 mg/kg) | Drug | TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions) |
|
| 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. | 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. | 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. | 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. | Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method. | 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. | 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. | 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. | 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. | 36 hrs after infusion |
| Circulating CD34+ Cell Counts in Peripheral Blood. | Baseline, 3 hours and 6 hours after infusion |
| Hualien City |
| Taiwan |
| Kaohsiung Medical University Hospital | Kaohsiung City | Taiwan |
| Chang-Gung Memorial Hospital Linkou | Linkou District | Taiwan |
| National Taiwan University Hospital | Taipei | Taiwan |
| Taipei Veterans General Hospital | Taipei | Taiwan |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Height | Mean | Standard Deviation | centimeters |
|
| Weight | Mean | Standard Deviation | kilogram |
|
| Body Mass Index | Mean | Standard Deviation | kilogram/ meter^2 |
|
| Diagnosis | Number | participants |
|
| 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) |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | ng/mL | 36 hrs after infusion |
|
|
|
| Secondary | Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood. | Posted | Mean | Standard Deviation | fold | Baseline, 3 hours and 6 hours after infusion |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | hr | 36 hrs after infusion |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | hr | 36 hrs after infusion |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | 1/hr | 36 hrs after infusion |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | hr*ng/mL | 36 hrs after infusion |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | hr*ng/mL | 36 hrs after infusion |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mL/ hr/kg | 36 hrs after infusion |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mL/kg | 36 hrs after infusion |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | mL/kg | 36 hrs after infusion |
|
|
|
| Secondary | Circulating CD34+ Cell Counts in Peripheral Blood. | Posted | Mean | Standard Deviation | cells/μL | Baseline, 3 hours and 6 hours after infusion |
|
|
|
| 2 |
| 7 |
| 6 |
| 7 |
| EG001 | 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) | 6 | 12 | 8 | 12 |
|
| AUTOLOGOUS STEM CELL TRANSPLANT | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment | Post-treatment SAE. Definitely not related to study drug |
|
| HOSPITALIZATION FOR BONE MARROW TRANSPLANTATION | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment | Post-treatment SAE. Definitely not related to study drug |
|
| AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment | Post-treatment SAE. Definitely not related to study drug |
|
| TREATMENT OF NON-HODGKIN LYMPHOMA | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment | Post-treatment SAE. Definitely not related to study drug |
|
| PEIPHERAL BLOOD STEM CELL HARVEST | Surgical and medical procedures | MedDRA 11.0 | Systematic Assessment | Post-treatment SAE. Definitely not related to study drug |
|
|
| ABNORMAL DATA OF INCREASE BILIRUBIN | Investigations | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Probably not related to study drug. |
|
| CARDIAC DISORDERS-OTHER:QT PROLONG AT 24HR-36HR AFTER INFUSION | Investigations | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Possible related to study drug. |
|
| CHEST TIGHTNESS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Probably not related to study drug. |
|
| CLONIC OF RIGHT KNEE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Definitely not related to study drug. |
|
| DIARRHEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. 1 probably related and 1 definitely related. |
|
| DIZZINESS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. 2 definitely not related and 1 possible related. |
|
| DRY COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Definitely not related. |
|
| ECCHYMOSIS OVER FEMORAL PUNCTURE SITE | General disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Definitely not related to study drug. |
|
| EMESIS | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Definitely not related to study drug. |
|
| FEVER | General disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Possible related to study drug. |
|
| HYPERCALCEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. All possible related to study drug. |
|
| HYPERTENSION | Vascular disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Definitely not related to study drug. |
|
| HYPOCALCEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Definitely not related to study drug. |
|
| HYPOCALCIUM | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Definitely not related to study drug. |
|
| HYPOKALEMIA | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Probably not related to study drug. |
|
| HYPOTENSION | Vascular disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Definitely not related to study drug. |
|
| HYPOTENSION BP 82/51MMHG | Vascular disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Possible related to study drug. |
|
| HYPOVOLEMIC HYPOTENSION BP 78/56MMHG | Vascular disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Possible related to study drug. |
|
| INCREASE ALANINE AMINOTRANS-FERASE | Investigations | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Probably not related to study drug. |
|
| INCREASE ALPHA-GANNA GLUTAMYL TRANSPEPTIDASE | Investigations | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Probably not related to study drug. |
|
| ITCHY SKIN | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Probably not related to study drug. |
|
| LEUKOCYTOSIS | Blood and lymphatic system disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment Ae. 3 possible related and 2 probably related. |
|
| LOW BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Probably related to study drug. |
|
| MILD ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Probably related to study drug. |
|
| MILD DIARRHEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Probably related to study drug. |
|
| MILD DIZZINESS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Possible related to study drug. |
|
| MILD HEADACHE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Possible related to study drug. |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Probably related to study drug. |
|
| NUMBNESS OF FACE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Definitely not related to study drug. |
|
| NUMBNESS OF FACE AND PALM | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Definitely not related to study drug. |
|
| NUMBNESS OF FACE HANDS AND LEGS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Definitely not related to study drug. |
|
| NUMBNESS OF LEGS AND LIPS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Definitely not related to study drug. |
|
| NUMBNESS OF LIPS | Nervous system disorders | MedDRA 11.0 | Systematic Assessment | Post-treatment AE. Definitely not related to study drug. |
|
PI needs to inform sponsor and asks for permission before he/she discusses or publishes trial results after the trial is completed.
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D008206 | Lymphatic Diseases |
|
| Fold increase (Maximum increase) |
|
Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.
| t-test, 2 sided |
| 0.038 |
P values less than 0.05 are considered statistically significant in this study. |
| 2-Sided |
| Superiority or Other (legacy) |
|
| PB CD34+ count (6 hours after infusion) |
|
| PB CD34+ count (Maximum increase) |
|