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

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