## Protocol Section
### Identification Module
**NCT ID:** NCT01018979

**Brief Title:** Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients

**Official Title:** A Phase II, Open-Label, Multi-Center 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

#### Organization Study ID Info
**ID:** TG-0054-02
#### Organization
**Class:** INDUSTRY
**Full Name:** GPCR Therapeutics, Inc.
### Status Module
#### Completion Date
**Date:** 2011-10

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-05-11

**Type:** ACTUAL

**Last Update Submit Date:** 2021-04-14

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2011-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-01-15

**Type:** ESTIMATED

**Results First Submit Date:** 2014-12-18

**Results First Submit QC Date:** 2015-01-13

#### Start Date
**Date:** 2010-02

**Status Verified Date:** 2021-04

#### Study First Post Date
**Date:** 2009-11-25
**Type:** ESTIMATED
**Study First Submit Date:** 2009-11-24
**Study First Submit QC Date:** 2009-11-24
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** GPCR Therapeutics, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Multiple Myeloma

- Non-Hodgkin Lymphoma

- Hodgkin Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 19

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

**Intervention Names:**

- Drug: TG-0054 (2.24 mg/kg)

**Label:** TG-0054 (2.24 mg/kg)

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

**Intervention Names:**

- Drug: TG-0054 (3.14 mg/kg)

**Label:** TG-0054 (3.14 mg/kg)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- TG-0054 (2.24 mg/kg)

**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

**Name:** TG-0054 (2.24 mg/kg)

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- TG-0054 (3.14 mg/kg)

**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

**Name:** TG-0054 (3.14 mg/kg)

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success.

**Measure:** 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).

**Time Frame:** 1 week

#### Secondary Outcomes

**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

**Measure:** Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

**Time Frame:** 36 hrs after infusion

**Measure:** Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.

**Time Frame:** Baseline, 3 hours and 6 hours after infusion

**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

**Measure:** Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

**Time Frame:** 36 hrs after infusion

**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

**Measure:** Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

**Time Frame:** 36 hrs after infusion

**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

**Measure:** Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

**Time Frame:** 36 hrs after infusion

**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

**Measure:** 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.

**Time Frame:** 36 hrs after infusion

**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

**Measure:** 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.

**Time Frame:** 36 hrs after infusion

**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

**Measure:** Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

**Time Frame:** 36 hrs after infusion

**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

**Measure:** Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

**Time Frame:** 36 hrs after infusion

**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.

**Measure:** Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD.

**Time Frame:** 36 hrs after infusion

**Measure:** Circulating CD34+ Cell Counts in Peripheral Blood.

**Time Frame:** Baseline, 3 hours and 6 hours after infusion

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Chiayi

**Country:** Taiwan

**Facility:** Chang-Gung Memorial Hospital Chiayi

**Location 2:**

**City:** Hualien

**Country:** Taiwan

**Facility:** Buddist Tzu Chi General Hospital

**Location 3:**

**City:** Kaohsiung

**Country:** Taiwan

**Facility:** Kaohsiung Medical University Hospital

**Location 4:**

**City:** Linkou

**Country:** Taiwan

**Facility:** Chang-Gung Memorial Hospital Linkou

**Location 5:**

**City:** Taipei

**Country:** Taiwan

**Facility:** National Taiwan University Hospital

**Location 6:**

**City:** Taipei

**Country:** Taiwan

**Facility:** Taipei Veterans General Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Taipei Veterans General Hospital, Taiwan

**Name:** Tzeon-Jye Chiou, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Buddist Tzu Chi General Hospital

**Name:** Tso-Fu Wang, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 3:**

**Affiliation:** Kaohsiung Medical University

**Name:** Sheng-Fung Lin, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 4:**

**Affiliation:** Chang Gung Memorial Hospital, Chiayi

**Name:** Chih-Cheng Chen, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 5:**

**Affiliation:** Chang Gung Memorial Hospital

**Name:** Po-Nan Wang, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 6:**

**Affiliation:** National Taiwan University Hospital

**Name:** Jih-Luh Tang, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000008232

- Term: Lymphoproliferative Disorders

- ID: D000008206

- Term: Lymphatic Diseases

- ID: D000007160

- Term: Immunoproliferative Disorders

- ID: D000007154

- Term: Immune System Diseases

- ID: D000020141

- Term: Hemostatic Disorders

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010265

- Term: Paraproteinemias

- ID: D000001796

- Term: Blood Protein Disorders

- ID: D000006402

- Term: Hematologic Diseases

- ID: D000006474

- Term: Hemorrhagic Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12058

- Name: Multiple Myeloma

- Relevance: HIGH

- As Found: Multiple Myeloma

- ID: M27588

- Name: Neoplasms, Plasma Cell

- Relevance: HIGH

- As Found: Multiple Myeloma

- ID: M11220

- Name: Lymphoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: M9751

- Name: Hodgkin Disease

- Relevance: HIGH

- As Found: Hodgkin's Disease

- ID: M11222

- Name: Lymphoma, Non-Hodgkin

- Relevance: HIGH

- As Found: Non-Hodgkin Lymphoma

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M11225

- Name: Lymphoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10206

- Name: Immunoproliferative Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M21977

- Name: Hemostatic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5059

- Name: Blood Coagulation Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13178

- Name: Paraproteinemias

- Relevance: LOW

- As Found: Unknown

- ID: M5077

- Name: Blood Protein Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M9490

- Name: Hematologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9560

- Name: Hemorrhagic Disorders

- Relevance: LOW

- As Found: Unknown

- ID: T3947

- Name: Multiple Myeloma

- Relevance: HIGH

- As Found: Multiple Myeloma

- ID: T3543

- Name: Lymphosarcoma

- Relevance: HIGH

- As Found: Lymphoma

- ID: T2817

- Name: Hodgkin Lymphoma

- Relevance: HIGH

- As Found: Hodgkin's Disease

### Condition Browse Module - Meshes

- ID: D000008223

- Term: Lymphoma

- ID: D000009101

- Term: Multiple Myeloma

- ID: D000054219

- Term: Neoplasms, Plasma Cell

- ID: D000008228

- Term: Lymphoma, Non-Hodgkin

- ID: D000006689

- Term: Hodgkin Disease

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** 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.

#### Event Groups

**Group ID:** EG000

**Title:** TG-0054 (2.24 mg/kg)

**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

**ID:** EG000

**Other Num Affected:** 6

**Other Num at Risk:** 7

**Serious Number Affected:** 2

**Serious Number At Risk:** 7

**Title:** TG-0054 (2.24 mg/kg)

**Group ID:** EG001

**Title:** TG-0054 (3.14 mg/kg)

**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

**ID:** EG001

**Other Num Affected:** 8

**Other Num at Risk:** 12

**Serious Number Affected:** 6

**Serious Number At Risk:** 12

**Title:** TG-0054 (3.14 mg/kg)

**Frequency Threshold:** 0

#### Other Events

**Term:** ABDOMINAL PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Probably related to study drug.

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** ABNORMAL DATA OF INCREASE BILIRUBIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Probably not related to study drug.

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** CARDIAC DISORDERS-OTHER:QT PROLONG AT 24HR-36HR AFTER INFUSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Possible related to study drug.

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** CHEST TIGHTNESS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Probably not related to study drug.

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** CLONIC OF RIGHT KNEE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Definitely not related to study drug.

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** DIARRHEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. 1 probably related and 1 definitely related.

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** DIZZINESS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. 2 definitely not related and 1 possible related.

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** DRY COUGH

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Definitely not related.

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** ECCHYMOSIS OVER FEMORAL PUNCTURE SITE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Definitely not related to study drug.

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** EMESIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Definitely not related to study drug.

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** FEVER

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Possible related to study drug.

**Organ System:** General disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** HYPERCALCEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. All possible related to study drug.

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** HYPERTENSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Definitely not related to study drug.

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** HYPOCALCEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Definitely not related to study drug.

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** HYPOCALCIUM

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Definitely not related to study drug.

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** HYPOKALEMIA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Probably not related to study drug.

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** HYPOTENSION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Definitely not related to study drug.

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** HYPOTENSION BP 82/51MMHG

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Possible related to study drug.

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** HYPOVOLEMIC HYPOTENSION BP 78/56MMHG

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Possible related to study drug.

**Organ System:** Vascular disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** INCREASE ALANINE AMINOTRANS-FERASE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Probably not related to study drug.

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** INCREASE ALPHA-GANNA GLUTAMYL TRANSPEPTIDASE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Probably not related to study drug.

**Organ System:** Investigations

**Source Vocabulary:** MedDRA 11.0

**Term:** ITCHY SKIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Probably not related to study drug.

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** LEUKOCYTOSIS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment Ae. 3 possible related and 2 probably related.

**Organ System:** Blood and lymphatic system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** LOW BACK PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Probably related to study drug.

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** MILD ABDOMINAL PAIN

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Probably related to study drug.

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** MILD DIARRHEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Probably related to study drug.

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** MILD DIZZINESS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Possible related to study drug.

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** MILD HEADACHE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Possible related to study drug.

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** NAUSEA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Probably related to study drug.

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** NUMBNESS OF FACE

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Definitely not related to study drug.

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** NUMBNESS OF FACE AND PALM

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Definitely not related to study drug.

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** NUMBNESS OF FACE HANDS AND LEGS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Definitely not related to study drug.

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** NUMBNESS OF LEGS AND LIPS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Definitely not related to study drug.

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

**Term:** NUMBNESS OF LIPS

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment AE. Definitely not related to study drug.

**Organ System:** Nervous system disorders

**Source Vocabulary:** MedDRA 11.0

#### Serious Events

**Term:** ADMISSION FOR PREPARATION OF PERIPHERAL BLOOD STEM CELL HARVEST

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment SAE. Definitely not related to study drug

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 7

**Group ID:** EG001

**Num Affected:** 3

**Num At Risk:** 12

**Term:** AUTOLOGOUS STEM CELL TRANSPLANT

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment SAE. Definitely not related to study drug

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 7

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Term:** HOSPITALIZATION FOR BONE MARROW TRANSPLANTATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment SAE. Definitely not related to study drug

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 7

**Group ID:** EG001

**Num At Risk:** 12

**Term:** AUTOLOGOUS HEMATOPOIETIC STEM CELL TRANSPLANTATION

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment SAE. Definitely not related to study drug

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 7

**Group ID:** EG001

**Num At Risk:** 12

**Term:** TREATMENT OF NON-HODGKIN LYMPHOMA

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment SAE. Definitely not related to study drug

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 7

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Term:** PEIPHERAL BLOOD STEM CELL HARVEST

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Post-treatment SAE. Definitely not related to study drug

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** MedDRA 11.0

##### Stats

**Group ID:** EG000

**Num At Risk:** 7

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 12

**Time Frame:** The whole study period, from Visit 1 (screening, day -14) to Visit 9 (7 days after the last dose)

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 7

**Group ID:** BG001

**Value:** 12

**Group ID:** BG002

**Value:** 19

**Units:** Participants

### Group

**ID:** BG000

**Title:** TG-0054 (2.24 mg/kg)

**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

### Group

**ID:** BG001

**Title:** TG-0054 (3.14 mg/kg)

**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 15.5

**Value:** 47.3

#### Measurement

**Group ID:** BG001

**Spread:** 9.3

**Value:** 52.4

#### Measurement

**Group ID:** BG002

**Spread:** 11.8

**Value:** 50.5

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 4

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 11

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 5

#### Measurement

**Group ID:** BG002

**Value:** 8

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.1

**Value:** 162.7

#### Measurement

**Group ID:** BG001

**Spread:** 8.6

**Value:** 158.7

#### Measurement

**Group ID:** BG002

**Spread:** 9.1

**Value:** 160.2

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 23.1

**Value:** 67.3

#### Measurement

**Group ID:** BG001

**Spread:** 10.2

**Value:** 60.6

#### Measurement

**Group ID:** BG002

**Spread:** 15.9

**Value:** 63.1

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 6.0

**Value:** 25.1

#### Measurement

**Group ID:** BG001

**Spread:** 3.0

**Value:** 24.0

#### Measurement

**Group ID:** BG002

**Spread:** 4.2

**Value:** 24.4

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 4

#### Measurement

**Group ID:** BG002

**Value:** 7

**Class Title:** Multiple myeloma

#### Measurement

**Group ID:** BG000

**Value:** 3

#### Measurement

**Group ID:** BG001

**Value:** 7

#### Measurement

**Group ID:** BG002

**Value:** 10

**Class Title:** Non-Hodgkin lymphoma

#### Measurement

**Group ID:** BG000

**Value:** 1

#### Measurement

**Group ID:** BG001

**Value:** 1

#### Measurement

**Group ID:** BG002

**Value:** 2

**Class Title:** Hodgkin disease

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Height
**Unit of Measure:** centimeters
### Measure 4
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Weight
**Unit of Measure:** kilogram
### Measure 5
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Body Mass Index
**Unit of Measure:** kilogram/ meter^2
### Measure 6
**Parameter Type:** NUMBER
**Title:** Diagnosis
**Unit of Measure:** participants
**Population Description:** 19 subjects met all eligibility criteria and received at least one dose of TG-0054.
## Results Section - More Information Module
### Certain Agreement
**Other Details:** PI needs to inform sponsor and asks for permission before he/she discusses or publishes trial results after the trial is completed.
**Restriction Type:** OTHER
**Restrictive Agreement:** True
### Point of Contact
**Email:** cetsai@taigenbiotech.com
**Organization:** TaiGen Biotechnology Co., Ltd.
**Phone:** +886-2-8177-7072
**Phone Extension:** 1211
**Title:** Chen-En Tsai, M.D., Ph.D.
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.023
**P-Value Comment:** P values less than 0.05 are considered statistically significant in this study.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** Analyze whether the mean fold increase from the baseline to the peak time change was significant or not.
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER_LEGACY
**Other Analysis Description:** 
**P-Value:** 0.038
**P-Value Comment:** P values less than 0.05 are considered statistically significant in this study.
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** 
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
### Outcome Measure 12
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 1
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 0
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 6995
- **Upper Limit:** 
- **Value:** 20971
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 18583
- **Upper Limit:** 
- **Value:** 29665
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.9
- **Upper Limit:** 
- **Value:** 7.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 6.1
- **Upper Limit:** 
- **Value:** 6.1
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 5.9
- **Upper Limit:** 
- **Value:** 6.4
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.2
- **Upper Limit:** 
- **Value:** 7.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 10.4
- **Upper Limit:** 
- **Value:** 7.8
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 9.1
- **Upper Limit:** 
- **Value:** 7.8
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7.5
- **Upper Limit:** 
- **Value:** 9.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 8.9
- **Upper Limit:** 
- **Value:** 10.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 8.4
- **Upper Limit:** 
- **Value:** 10.0
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0
- **Upper Limit:** 
- **Value:** 0.25
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0
- **Upper Limit:** 
- **Value:** 0.25
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.4
- **Upper Limit:** 
- **Value:** 4.65
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.6
- **Upper Limit:** 
- **Value:** 4.28
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.01
- **Upper Limit:** 
- **Value:** 0.15
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.02
- **Upper Limit:** 
- **Value:** 0.16
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7034
- **Upper Limit:** 
- **Value:** 43610
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 12153
- **Upper Limit:** 
- **Value:** 55814
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 7039
- **Upper Limit:** 
- **Value:** 43713
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 12170
- **Upper Limit:** 
- **Value:** 55920
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 9.4
- **Upper Limit:** 
- **Value:** 52.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 13.0
- **Upper Limit:** 
- **Value:** 58.6
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 62
- **Upper Limit:** 
- **Value:** 351
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 112
- **Upper Limit:** 
- **Value:** 366
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 64
- **Upper Limit:** 
- **Value:** 179
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 76
- **Upper Limit:** 
- **Value:** 193
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.7
- **Upper Limit:** 
- **Value:** 1.0
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.5
- **Upper Limit:** 
- **Value:** 0.9
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 0.6
- **Upper Limit:** 
- **Value:** 1.0
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.0
- **Upper Limit:** 
- **Value:** 5.7
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.1
- **Upper Limit:** 
- **Value:** 4.0
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 2.9
- **Upper Limit:** 
- **Value:** 4.6
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.9
- **Upper Limit:** 
- **Value:** 6.3
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.7
- **Upper Limit:** 
- **Value:** 4.3
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 3.3
- **Upper Limit:** 
- **Value:** 5.1
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 4.4
- **Upper Limit:** 
- **Value:** 7.8
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 3.7
- **Upper Limit:** 
- **Value:** 5.2
- **Comment:** 
- **Group ID:** OG002
- **Lower Limit:** 
- **Spread:** 4.1
- **Upper Limit:** 
- **Value:** 6.5
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Patients who met the target CD34+ cell collection of ≧2 x 106 cells/kg after two apheresis sessions were classified as achieving mobilization success.
**Parameter Type:** NUMBER
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 1 week
**Title:** 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).
**Type:** PRIMARY
**Unit of Measure:** participants
##### Group
**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG000
**Title:** TG-0054 (2.24 mg/kg)
##### Group
**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG001
**Title:** TG-0054 (3.14 mg/kg)
#### Outcome Measure 2
**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 36 hrs after infusion
**Title:** Maximum Plasma Concentration (Cmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
**Type:** SECONDARY
**Unit of Measure:** ng/mL
##### Group
**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG000
**Title:** TG-0054 (2.24 mg/kg)
##### Group
**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG001
**Title:** TG-0054 (3.14 mg/kg)
#### Outcome Measure 3
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 3 hours and 6 hours after infusion
**Title:** Fold Increase of Circulating CD34+ Cell Counts in Peripheral Blood.
**Type:** SECONDARY
**Unit of Measure:** fold
##### Group
**Description:** 7 patients with MM were enrolled.
**ID:** OG000
**Title:** Multiple Myeloma (MM)
##### Group
**Description:** 10 patients and 2 patients with NHL and HD were enrolled, respectively.
**ID:** OG001
**Title:** Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)
##### Group
**Description:** All patents = MM + NHL + HD
**ID:** OG002
**Title:** All Patients
#### Outcome Measure 4
**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 36 hrs after infusion
**Title:** Time at Which Maximum Plasma Concentration is Observed (Tmax) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
**Type:** SECONDARY
**Unit of Measure:** hr
##### Group
**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG000
**Title:** TG-0054 (2.24 mg/kg)
##### Group
**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG001
**Title:** TG-0054 (3.14 mg/kg)
#### Outcome Measure 5
**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 36 hrs after infusion
**Title:** Terminal Elimination Half-life (t1/2) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
**Type:** SECONDARY
**Unit of Measure:** hr
##### Group
**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG000
**Title:** TG-0054 (2.24 mg/kg)
##### Group
**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG001
**Title:** TG-0054 (3.14 mg/kg)
#### Outcome Measure 6
**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 36 hrs after infusion
**Title:** Terminal Elimination Rate Constant (λz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
**Type:** SECONDARY
**Unit of Measure:** 1/hr
##### Group
**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG000
**Title:** TG-0054 (2.24 mg/kg)
##### Group
**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG001
**Title:** TG-0054 (3.14 mg/kg)
#### Outcome Measure 7
**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 36 hrs after infusion
**Title:** 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.
**Type:** SECONDARY
**Unit of Measure:** hr*ng/mL
##### Group
**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG000
**Title:** TG-0054 (2.24 mg/kg)
##### Group
**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG001
**Title:** TG-0054 (3.14 mg/kg)
#### Outcome Measure 8
**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 36 hrs after infusion
**Title:** 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.
**Type:** SECONDARY
**Unit of Measure:** hr*ng/mL
##### Group
**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG000
**Title:** TG-0054 (2.24 mg/kg)
##### Group
**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG001
**Title:** TG-0054 (3.14 mg/kg)
#### Outcome Measure 9
**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 36 hrs after infusion
**Title:** Clearance (CL) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
**Type:** SECONDARY
**Unit of Measure:** mL/ hr/kg
##### Group
**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG000
**Title:** TG-0054 (2.24 mg/kg)
##### Group
**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG001
**Title:** TG-0054 (3.14 mg/kg)
#### Outcome Measure 10
**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 36 hrs after infusion
**Title:** Volume of Distribution at the Terminal State (Vz) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
**Type:** SECONDARY
**Unit of Measure:** mL/kg
##### Group
**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG000
**Title:** TG-0054 (2.24 mg/kg)
##### Group
**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG001
**Title:** TG-0054 (3.14 mg/kg)
#### Outcome Measure 11
**Description:** Plasma concentrations of TG-0054 were determinate by validated LC-MS/MS method.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** 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.
**Reporting Status:** POSTED
**Time Frame:** 36 hrs after infusion
**Title:** Volume of Distribution at Steady State (Vss) of TG-0054 in 12 Consented Patients With MM, NHL or HD.
**Type:** SECONDARY
**Unit of Measure:** mL/kg
##### Group
**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG000
**Title:** TG-0054 (2.24 mg/kg)
##### Group
**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** OG001
**Title:** TG-0054 (3.14 mg/kg)
#### Outcome Measure 12
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline, 3 hours and 6 hours after infusion
**Title:** Circulating CD34+ Cell Counts in Peripheral Blood.
**Type:** SECONDARY
**Unit of Measure:** cells/μL
##### Group
**Description:** 7 patients with MM were enrolled.
**ID:** OG000
**Title:** Multiple Myeloma (MM)
##### Group
**Description:** 10 patients and 2 patients with NHL and HD were enrolled, respectively.
**ID:** OG001
**Title:** Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)
##### Group
**Description:** All patents = MM + NHL + HD
**ID:** OG002
**Title:** All Patients
### Participant Flow Module
#### Group
**Description:** TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** FG000
**Title:** TG-0054 (2.24 mg/kg)
#### Group
**Description:** TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
**ID:** FG001
**Title:** TG-0054 (3.14 mg/kg)
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Peak CD34+ cell count in PB < 10 cell/uL
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 9
##### Withdraw
**Type:** Not received at least one dose
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 13
##### Milestone
**Type:** Received at Least One Dose
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 7
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 12
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 4
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 3
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 3
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 10
**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.
**Has Results:** True