Th1/Tc1 Immunotherapy Following Stem Cell Transplantation in Multiple Myeloma

Exclusion Criteria

• •For Cohort A only, high-dose chemotherapy and AHCT must be planned; with amendment K, post-transplant maintenance therapy will not be permitted.
• •Karnofsky performance status (KPS) of 70% or greater. Lower KPS down to 50% may be acceptable if the restriction of activity is solely due to intractable pain from myeloma lesions.
• •Ejection fraction (EF) by multi-gated acquisition scan (MUGA) or two-dimensional (2-D) echocardiogram within institution normal limits. In case of low EF, the subject may remain eligible after a stress echocardiogram is performed if the EF is more than 35% and if the increase in EF with stress is estimated at 10% or more.
• •Serum creatinine less than or equal to 2.5 mg/dl,
• •Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal to 3 times the upper limit of normal.
• •Bilirubin less than or equal to1.5 (except if due to Gilbert's disease).
• •Corrected carbon monoxide diffusing capacity (DLCO) greater than or equal to 50% on Pulmonary Function Tests
• •No history of abnormal bleeding tendency or predisposition to repeated infections.
• •Patients must be able to give informed consent
• •Prior allogeneic stem cell transplantation
• •Hypertension not adequately controlled by 3 or less medications.
• •History of cerebro-vascular accident within 6 months of enrollment.
• •History of documented pulmonary embolus within 6 months of enrollment.
• •Clinically significant cardiac pathology: myocardial infarction within 6 months prior to enrollment, Class III or IV heart failure according to New York Heart Association (NYHA), uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
• •Patients with a history of coronary artery bypass grafting or angioplasty will receive a cardiology evaluation and be considered on a case-by-case basis.
• •Human immunodeficiency virus (HIV) seropositive
• •Patients known or found to be pregnant or who is unwilling to stop breast-feeding.
• •Patients of childbearing age who are unwilling to practice contraception or other means of avoiding pregnancy.
• •Patients may be excluded at the discretion of the principal investigator (PI) if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.