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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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.
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Response Rates by Blade Criteria
Number of participants with each disease response category utilizing the Blade criteria: * Complete Response (CR): Defined as negative serum and urine immunofixation and a bone marrow aspirate with \< 5% plasma cells. * Near Complete Response (nCR): Defined as negative serum and urine paraprotein, positive serum and/or urine immunofixation, and a bone marrow aspirate with \< 5% plasma cells. * Very Good Partial Response (VGPR): Defined as negative serum and urine paraprotein with positive serum and/or urine immunofixation; or a 90% decrease in serum paraprotein with urine paraprotein \< 100 mg/24 hours. * Partial Response (PR): Defined as a 50-89% decrease in serum paraprotein. * Minimal Response (MR): Defined as a 25-49% decrease in serum paraprotein. * Stable Disease (SD): Defined as not falling into any other response category. * Overall response rate (ORR): Total of CR, nCR, VGPR, and PR.
Time frame: Up to 1 year
Progression-free Survival
Median number of months that participants were alive without disease relapse or progression (progression-free survival).
Time frame: Up to 5 years
Overall Survival
Number of participants alive at 5 years (overall survival).
Time frame: Up to 5 years
Feasibility as Measured by Participant Withdrawal or Removal
Number of participants who withdrew or were removed from the study for reasons other than lack of efficacy prior to completion.
Time frame: Up to 1 year
Safety as Measured by Grade 3-5 Adverse Events
Number of participants who experienced at least one grade 3-5 adverse event by CTCAE 3.0 that was attributed to MILs or the myeloma vaccine.
Time frame: Up to 1 year
Anti-tumor Immune Response
* Evaluate tumor specific responses in blood and bone marrow * Examine T cell responses to DC-pulsed myeloma cell lines * Examine induction of novel antibody responses
Time frame: Days 60, 180, and 360
The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (RANKL/OPG Ratio)
Time frame: Days 60, 180, and 360
The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Serum C Telopeptide Levels)
Serum C Telopeptide
Time frame: Days 60, 180, 360
The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (bAlkaline Phosphatase Levels)
bAlkaline phosphatase
Time frame: Days 60, 180, 360
The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Osteocalcin Levels)
Osteocalcin
Time frame: Days 60, 180, 360
Effect of aMILs on Clonogenic Myeloma Precursors
• Examine side population of CD19 enriched PBLs throughout study.
Time frame: Days 60, 180, and 360
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