Id-KLH Vaccine + T Cells in Subjects With Myeloma Undergoing Transplant

Inclusion Criteria

SCREEN #1 (Visit 1) Step 1:

• Diagnosis of symptomatic multiple myeloma.
• Less than 10 months after initiation of systemic therapy.
• One or two lines of induction therapy with commonly used regimens.
• Age greater than or equal to 18 years to less than or equal to 70 years at the time of enrollment.
• IgG paraprotein (not of IgG3 subtype) with a paraprotein peak (M-spike) of ≥0.2 g/dL. Alternatively subjects who have previously stored purified Id-specific protein on other clinical or laboratory protocols.
• Echocardiogram or MUGA with an ejection fraction of 45% or more and no uncompensated congestive heart failure or uncontrolled arrhythmias.
• Adequate pulmonary function as defined by FEV1, FVC and actual or corrected DLCO of 50% or greater of the predicted value for age, sex and size.
• Adequate renal function as defined by creatinine of 2.0 mg/dl or less or a creatinine clearance of 40cc/min or more.
• Adequate hepatic function as defined by a total bilirubin of 2.0 mg/dl or less and AST and ALT less than 2 times upper limit of normal.
• Ability to sign written informed consent.
• Karnofsky performance status of at least 80% or more.
• Negative serum Beta HCG test in women of child bearing potential and agree to use a medically acceptable form of birth control while on the study drugs.

Exclusion:

• Subjects with melphalan-based induction
• Active uncontrolled infection
• HIV+ or active hepatitis B or C as defined by positive viral load or serology.
• Pre-existing autoimmune diseases, with exception of Hashimoto's thyroiditis.
• Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during Tcell collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of inhaled steroids is permitted as well.
• Prior autologous or allogeneic transplant.

For this study, there will be no exceptions to eligibility granted.

4.2 PRE-VACCINE #1 ASSESSMENT (Visit 3) Step 2

Subjects must meet the following criteria to proceed with vaccination:

• Less than 9 months from randomization.
• Adequate renal function as defined by creatinine of 2.0 mg/dl or less or a creatinine clearance of 40cc/min or more.
• Adequate hepatic function as defined by a total bilirubin of 2.0 mg/dl or less and AST and ALT less than 2 times upper limit of normal.
• Karnofsky performance status of at least 80% or more.
• At least 2 weeks from last chemotherapy.
• Negative serum Beta HCG test in women of child bearing potential.