Safety and PK/PD of TG-0054 in Multiple Myeloma, Non-Hodgkin Lymphoma and Hodgkin Disease Patients
Condition: Multiple Myeloma; Non-Hodgkin Lymphoma; Hodgkin Disease
MeSH terms: Lymphoma; Multiple Myeloma; Neoplasms, Plasma Cell; Lymphoma, Non-Hodgkin; Hodgkin Disease
Intervention: TG-0054 (2.24 mg/kg); TG-0054 (3.14 mg/kg)
Intervention description: 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 TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

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