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NCT01045460 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2021-04-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Response Rates by Blade Criteria

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Overall Survival

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outcome · POSTED

Feasibility as Measured by Participant Withdrawal or Removal

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outcome · POSTED

Safety as Measured by Grade 3-5 Adverse Events

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outcome · POSTED

Anti-tumor Immune Response

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outcome · POSTED

The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (RANKL/OPG Ratio)

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outcome · POSTED

The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Serum C Telopeptide Levels)

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outcome · POSTED

The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (bAlkaline Phosphatase Levels)

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outcome · POSTED

The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Osteocalcin Levels)

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outcome · POSTED

Effect of aMILs on Clonogenic Myeloma Precursors

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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
healthy Volunteers
false
maximum Age
70 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4.
    intervention Names
    1. Biological: Activated marrow infiltrating lymphocytes
    2. Drug: Cyclophosphamide
    3. Biological: Filgrastim
    4. Procedure: Leukapheresis
    5. Drug: Melphalan
    6. Biological: Autologous stem cell transplant
    label
    ASCT + MILs
    type
    EXPERIMENTAL
  2. description
    Cyclophosphamide and filgrastim will be given to mobilize peripheral blood stem cells. Leukapheresis will be performed to collect peripheral blood from which activated marrow infiltrating lymphocytes will be produced. A melphalan conditioning regimen will be used prior to autologous stem cell transplant, and the MILs product will be administered on Days 3 and 4. The allogeneic myeloma vaccine will be administered on Days 21, 60, 180, and 300.
    intervention Names
    1. Biological: Activated marrow infiltrating lymphocytes
    2. Biological: Allogeneic Myeloma Vaccine
    3. Drug: Cyclophosphamide
    4. Biological: Filgrastim
    5. Procedure: Leukapheresis
    6. Drug: Melphalan
    7. Biological: Autologous stem cell transplant
    label
    ASCT + MILs + vaccine
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. ASCT + MILs
    2. ASCT + MILs + vaccine
    description
    Administered on Days 3 and 4.
    name
    Activated marrow infiltrating lymphocytes
    other Names
    1. MILs
    2. aMILs
    type
    BIOLOGICAL
  2. arm Group Labels
    1. ASCT + MILs + vaccine
    description
    Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300.
    name
    Allogeneic Myeloma Vaccine
    type
    BIOLOGICAL
  3. arm Group Labels
    1. ASCT + MILs
    2. ASCT + MILs + vaccine
    description
    Administered at 2.5 g/m\^2.
    name
    Cyclophosphamide
    other Names
    1. Cytoxan
    type
    DRUG
  4. arm Group Labels
    1. ASCT + MILs
    2. ASCT + MILs + vaccine
    description
    Administered post cyclophosphamide daily until leukapheresis.
    name
    Filgrastim
    other Names
    1. G-CSF
    type
    BIOLOGICAL
  5. arm Group Labels
    1. ASCT + MILs
    2. ASCT + MILs + vaccine
    description
    Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts.
    name
    Leukapheresis
    other Names
    1. Apheresis
    type
    PROCEDURE
  6. arm Group Labels
    1. ASCT + MILs
    2. ASCT + MILs + vaccine
    description
    100 mg/m\^2/day given on Days -2 and -1.
    name
    Melphalan
    other Names
    1. Alkeran
    type
    DRUG
  7. arm Group Labels
    1. ASCT + MILs
    2. ASCT + MILs + vaccine
    description
    Infused on Day 0.
    name
    Autologous stem cell transplant
    other Names
    1. ASCT
    type
    BIOLOGICAL
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
36
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Response Rates by Blade Criteria
    time Frame
    Up to 1 year
secondary Outcomes
  1. description
    Median number of months that participants were alive without disease relapse or progression (progression-free survival).
    measure
    Progression-free Survival
    time Frame
    Up to 5 years
  2. description
    Number of participants alive at 5 years (overall survival).
    measure
    Overall Survival
    time Frame
    Up to 5 years
  3. description
    Number of participants who withdrew or were removed from the study for reasons other than lack of efficacy prior to completion.
    measure
    Feasibility as Measured by Participant Withdrawal or Removal
    time Frame
    Up to 1 year
  4. description
    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.
    measure
    Safety as Measured by Grade 3-5 Adverse Events
    time Frame
    Up to 1 year
  5. description
    * 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
    measure
    Anti-tumor Immune Response
    time Frame
    Days 60, 180, and 360
  6. measure
    The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (RANKL/OPG Ratio)
    time Frame
    Days 60, 180, and 360
  7. description
    Serum C Telopeptide
    measure
    The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Serum C Telopeptide Levels)
    time Frame
    Days 60, 180, 360
  8. description
    bAlkaline phosphatase
    measure
    The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (bAlkaline Phosphatase Levels)
    time Frame
    Days 60, 180, 360
  9. description
    Osteocalcin
    measure
    The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Osteocalcin Levels)
    time Frame
    Days 60, 180, 360
  10. description
    • Examine side population of CD19 enriched PBLs throughout study.
    measure
    Effect of aMILs on Clonogenic Myeloma Precursors
    time Frame
    Days 60, 180, and 360
Full study description
brief 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.
Source references
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice