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

NCT01018979 | Completed Phase 2 Results DMC

• 1 other identifier: TG-0054-02
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 6

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

Multiple Myeloma; Non-Hodgkin Lymphoma; Hodgkin Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (11)

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

  36 hrs after infusion

• 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

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

  36 hrs after infusion

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

  36 hrs after infusion

Study Arms (2)

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)

Drug: TG-0054 (2.24 mg/kg)

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)

Drug: TG-0054 (3.14 mg/kg)

Interventions

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)

TG-0054 (2.24 mg/kg)

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)

TG-0054 (3.14 mg/kg)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GPCR Therapeutics, Inc.: lead

Study Sites (6)

Chang-Gung Memorial Hospital Chiayi

Chiayi City, Taiwan

Location

Buddist Tzu Chi General Hospital

Hualien City, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Location

Chang-Gung Memorial Hospital Linkou

Linkou District, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Multiple Myeloma; Lymphoma, Non-Hodgkin; Hodgkin Disease

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases

Results Point of Contact

• Title: Chen-En Tsai, M.D., Ph.D.
• Organization: TaiGen Biotechnology Co., Ltd.

cetsai@taigenbiotech.com

+886-2-8177-7072

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: February 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 11, 2021
• Results First Posted: January 15, 2015

Record last verified: 2021-04

Locations

TW (6)