| Primary | 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.
| Only participants who had ASCT were evaluated for response. Three participants on the ASCT + MILs arm and two participants on the ASCT + MILs + vaccine arm were removed from study prior to ASCT and were therefore not evaluable for this outcome. | Posted | | Count of Participants | | Participants | | Up to 1 year | | | | ID | Title | Description |
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| OG000 | ASCT + MILs | 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. | | OG001 | ASCT + MILs + Vaccine | 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. |
| | | Title | Denominators | Categories |
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| CR | | | | nCR | | |
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| Secondary | Progression-free Survival | Median number of months that participants were alive without disease relapse or progression (progression-free survival). | Only participants who had ASCT were evaluated for response. Three participants on the ASCT + MILs arm and two participants on the ASCT + MILs + vaccine arm were removed from study prior to ASCT and were therefore not evaluable for this outcome. | Posted | | Median | 95% Confidence Interval | months | | Up to 5 years | | | | ID | Title | Description |
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| OG000 | ASCT + MILs | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 and -1. Autologous stem cell transplant: Infused on Day 0. | | OG001 | ASCT + MILs + Vaccine | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 |
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| Secondary | Overall Survival | Number of participants alive at 5 years (overall survival). | Only participants who had ASCT were evaluated for response. Three participants on the ASCT + MILs arm and two participants on the ASCT + MILs + vaccine arm were removed from study prior to ASCT and were therefore not evaluable for this outcome. | Posted | | Count of Participants | | Participants | | Up to 5 years | | | | ID | Title | Description |
|---|
| OG000 | ASCT + MILs | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 and -1. Autologous stem cell transplant: Infused on Day 0. | | OG001 | ASCT + MILs + Vaccine | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | ASCT + MILs | 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. | | OG001 | ASCT + MILs + Vaccine | 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. |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | Up to 1 year | | | | ID | Title | Description |
|---|
| OG000 | ASCT + MILs | 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. | | OG001 | ASCT + MILs + Vaccine | 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. |
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| Secondary | 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
| This measure was not assessed. Data was not collected. | Posted | | | | | | Days 60, 180, and 360 | | | | ID | Title | Description |
|---|
| OG000 | ASCT + MILs | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 and -1. Autologous stem cell transplant: Infused on Day 0. | | OG001 | ASCT + MILs + Vaccine | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 |
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| Secondary | The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (RANKL/OPG Ratio) | | This measure was not assessed. Data was not collected. | Posted | | | | | | Days 60, 180, and 360 | | | | ID | Title | Description |
|---|
| OG000 | ASCT + MILs | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 and -1. Autologous stem cell transplant: Infused on Day 0. | | OG001 | ASCT + MILs + Vaccine | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 |
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| Secondary | The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Serum C Telopeptide Levels) | | This measure was not assessed. Data was not collected. | Posted | | | | | | Days 60, 180, 360 | | | | ID | Title | Description |
|---|
| OG000 | ASCT + MILs | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 and -1. Autologous stem cell transplant: Infused on Day 0. | | OG001 | ASCT + MILs + Vaccine | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 |
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| Secondary | The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (bAlkaline Phosphatase Levels) | | This measure was not assessed. Data was not collected. | Posted | | | | | | Days 60, 180, 360 | | | | ID | Title | Description |
|---|
| OG000 | ASCT + MILs | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 and -1. Autologous stem cell transplant: Infused on Day 0. | | OG001 | ASCT + MILs + Vaccine | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 |
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| Secondary | The Effect of aMILs on Osteoclastogenesis as Measured by Bone Turnover (Osteocalcin Levels) | | This measure was not assessed. Data was not collected. | Posted | | | | | | Days 60, 180, 360 | | | | ID | Title | Description |
|---|
| OG000 | ASCT + MILs | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 and -1. Autologous stem cell transplant: Infused on Day 0. | | OG001 | ASCT + MILs + Vaccine | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 |
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| Secondary | Effect of aMILs on Clonogenic Myeloma Precursors | • Examine side population of CD19 enriched PBLs throughout study. | This measure was not assessed. Data was not collected. | Posted | | | | | | Days 60, 180, and 360 | | | | ID | Title | Description |
|---|
| OG000 | ASCT + MILs | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 and -1. Autologous stem cell transplant: Infused on Day 0. | | OG001 | ASCT + MILs + Vaccine | 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. Activated marrow infiltrating lymphocytes: Administered on Days 3 and 4. Allogeneic Myeloma Vaccine: Allogeneic granulocyte macrophage colony-stimulating factor (GM-CSF)-based myeloma cellular vaccine. Administered on Days 21, 60, 180, and 300. Cyclophosphamide: Administered at 2.5 g/m^2. Filgrastim: Administered post cyclophosphamide daily until leukapheresis. Leukapheresis: Performed approximately 12 days post cyclophosphamide. Exact date depends on peripheral blood CD34+ cell counts. Melphalan: 100 mg/m^2/day given on Days -2 |
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