A Study to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 Alone or in Combination With G-CSF in Patients With Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease
This study is currently recruiting participants.
Verified August 2012 by TaiGen Biotechnology Co., Ltd.
Information provided by (Responsible Party):
TaiGen Biotechnology Co., Ltd.
First received: October 13, 2011
Last updated: August 9, 2012
Last verified: August 2012
This Phase II study is to Evaluate the Safety, Pharmacokinetics, and Hematopoietic Stem Cell Mobilization of TG-0054 alone or in combination with G-CSF in Patients with Multiple Myeloma, Non-Hodgkin Lymphoma or Hodgkin Disease.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Primary Outcome Measures:
- Total number of HSCs collected within 4 leukapheresis sessions after TG-0054 (3.14 mg/kg) alone or in combination with G-CSF mobilization in patients with multiple myeloma, non-Hodgkins's lymphoma or Hodgkin's disease. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The average number of leukapheresis sessions required to collect greater or equal to 2 x10^6 CD34+ cells/kg or greater or equal to 5 x10^6 CD34+ cells/kg. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- The safety of TG-0054 in patients with multiple myeloma, non-Hodgkins's lymphoma or Hodgkin's disease [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
All adverse events will be coded according to the MedDRA dictionary, and be limited to events related or not related to study drug.
- The PK of TG-0054 [ Time Frame: pre-dose, -2,0,4,8,12,16,24,36,48,and 72 hr after dosing. ] [ Designated as safety issue: No ]
Pharmacokinetics parameters include Cmax, Area Under Curve, Tmax, Ae%, and T1/2.
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
Experimental: TG-0054 (3.14 mg/kg)
3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)
|Ages Eligible for Study:
||18 Years to 70 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Received radiation therapy to the pelvis
- Received greater or equal to 4 cycles of lenalidomide
- Evidence of bone marrow involvement of lymphoma in NHL patients
- Failed previous stem cell collection [failed to collect 2 x 106 CD34+ cells/kg within 4 leukapheresis 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 being treated with anti-coagulant
- 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
- Patients with proliferative retinopathy
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01458288
|Stony Brook University Hospital
|Stony Brook, New York, United States, 11794 |
|Contact: Michael W. Schuster, M.D. 631-444-3577 |
TaiGen Biotechnology Co., Ltd.
||Michael W. Schuster, M.D.
||Stony Brook University Hospital
No publications provided
||TaiGen Biotechnology Co., Ltd.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 13, 2011
||August 9, 2012
||United States: Food and Drug Administration
Taiwan: Department of Health
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 21, 2013
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Immune System Diseases
Blood Protein Disorders