Trial of Activated Marrow Infiltrating Lymphocytes Alone or in Conjunction With an Allogeneic Granulocyte Macrophage Colony-stimulating Factor (GM-CSF)-Based Myeloma Cellular Vaccine in the Autologous Transplant Setting in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Activated marrow infiltrating lymphocytes; Allogeneic Myeloma Vaccine; Cyclophosphamide; Filgrastim; Leukapheresis; Melphalan; Autologous stem cell transplant
Intervention description: Administered on Days 3 and 4.; Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.; Administered at 2.5 g/m^2.; Administered post cyclophosphamide daily until leukapheresis.; Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.; 100 mg/m^2/day given on Days -2 and -1.; Infused on Day 0.
Intervention MeSH terms: Cyclophosphamide; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: multiple myeloma

Summary:

      Patient Population: Patients with active myeloma (Stage II/III) that have completed induction
      therapy and are eligible for an autologous stem cell transplant.

      Number of Patients: Will treat a total of 32 evaluable patients in a 1:1 randomization of
      aMILs vs aMILs plus vaccine. An evaluable patient is defined as one which has received the
      activated MILs and is at least 6 months post-transplant.

      Study Objectives:

      Disease response as determined by the Blade' criteria will be the primary endpoint of the
      trial at one year.

      Additional study endpoints include progression free survival, parameters of T cell
      reconstitution, anti-tumor immune responses as well as the effect on osteoclastogenesis and
      clonogenic myeloma precursor cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Durie-Salmon Stage II or III multiple myeloma

          -  Newly diagnosed either prior to receiving treatment or having completed induction
             therapy

          -  Relapsed myeloma not previously transplanted within the past 5 years

          -  Measurable serum and/or urine M-protein from prior to induction therapy documented and
             available. A positive serum free lite assay is acceptable

          -  Age greater than 18 years old

          -  ECOG performance status of 0 - 2

          -  Meet all institutional requirements for autologous stem cell transplantation

          -  The patient must be able to comprehend and have signed the informed consent

        Exclusion Criteria:

          -  Diagnosis of any of the following plasma cell disorders: POEMS syndrome (plasma cell
             dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein
             [M-protein] and skin changes) Non-secretory myeloma (no measurable protein on Serum
             Free Lite Assay)

          -  Plasma cell leukemia

          -  Amyloidosis

          -  Use of corticosteroids (glucocorticoids) within 21 days of pre-transplant vaccine or
             bone marrow collection

          -  Use of any myeloma-specific therapy other than lenalidomide within 21 days of
             pre-transplant vaccine

          -  In a complete remission at the time of bone marrow collection

          -  Infection requiring treatment with antibiotics, antifungal, or antiviral agents within
             seven days of vaccination or bone marrow collection

          -  Participation in any clinical trial, within four weeks prior to vaccination or bone
             marrow collection on this trial, which involved an investigational drug or device

          -  History of malignancy other than multiple myeloma within five years of vaccination or
             bone marrow collection, except adequately treated basal or squamous cell skin cancer

          -  Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic
             lupus erythematosis) requiring systemic treatment. Hypothyroidism without evidence of
             Grave's Disease or Hashimoto's thyroiditis is permitted

          -  Evidence of spinal cord compression at time of transplant