Id-KLH Vaccine + T Cells in Subjects With Myeloma Undergoing Transplant
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: CD3/CD28
Intervention description: CD3/CD28 activated autologous lymphocytes intravenously
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adult; symptomatic multiple myeloma; myeloma; diagnosis within 12 months of initiation of systemic therapy

Summary:

      This study will enroll myeloma subjects undergoing autotransplantation. The primary objective
      of this study is to evaluate whether infusions of Id-KLH primed CD3/CD28 activated autologous
      lymphocytes mediate a more intense Id-specific immunity than non Id-KLH primed CD3/CD28
      activated autologous lymphocytes. There will be 2 arms in the study, one receiving a DLI with
      non Id-KLH vaccine and one receiving aDLI with Id-KLH vaccine.
    

Eligibility criteria:

        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.