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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| 998003 | Other Identifier | Mayo Clinic Cancer Center | |
| 789-99 | Other Identifier | Mayo Clinic IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
RATIONALE: Biological therapies, such as interferon-gamma and aldesleukin, may stimulate the immune system in different ways and stop cancer cells from growing. Vaccines made from a person's white blood cells may help the body build an effective immune response to kill cancer cells. Giving biological therapy together with vaccine therapy may kill more cancer cells.
PURPOSE: This randomized phase II trial is studying how well giving aldesleukin or interferon gamma together with vaccine therapy works in treating patients with multiple myeloma.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are stratified according to gender (male vs female) and prior treatment (post-chemotherapy vs post-peripheral blood stem cell transplantation). Patients are randomized to 1 of 2 arms.
In both arms, patients undergo apheresis for collection of peripheral blood mononuclear cells for generation of dendritic cells (DC) on days 0, 14, and 28. APC8020 is generated by loading DC with immunoglobulin idiotype prepared from the patient's serum.
In both arms, treatment continues in the absence of disease progression.
Peripheral blood samples are collected at baseline and on day 5 of courses 1 and 4 for cytokine immunomodulatory studies, including immunophenotyping for lymphocyte phenotypic markers (CD69, CD40L, CD25, CD30, CD71, CDW137, CD134, and HLADR) by flow cytometry and immunofluorescence; T-cell spectratyping by PCR and RT-PCR; T-cell proliferation to idiotype protein; and CTL and T-helper response by flow cytometry.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months thereafter.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aldesleukin | Biological | |||
| idiotype-pulsed autologous dendritic cell vaccine APC8020 | Biological | |||
| recombinant interferon gamma | Biological | |||
| polymerase chain reaction | Genetic | |||
| reverse transcriptase-polymerase chain reaction | Genetic | |||
| flow cytometry | Other | |||
| laboratory biomarker analysis | Other |
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed response (i.e., clinical or immunological) |
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DISEASE CHARACTERISTICS:
Diagnosis of multiple myeloma
Plateau phase multiple myeloma (status post chemotherapy or status post-peripheral blood cell transplantation), meeting the following criteria:
Serum and urine monoclonal (M) protein values must be stable (< 20% variation) or must have disappeared
Serum M protein < 1 g/dL, and 1 of the following:
Urine M protein < 200 mg/24 hours by electrophoresis on 2 separate occasions for a period of ≥ 4 weeks
Serum M protein spike ≤ 2.0 g/dL
No progressive disease after prior autologous stem cell transplantation or chemotherapy
No non-secretory or light chain myeloma
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Q. Lacy, MD | Mayo Clinic | Study Chair |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C082598 | aldesleukin |
| D007371 | Interferon-gamma |
| D016133 | Polymerase Chain Reaction |
| D020133 | Reverse Transcriptase Polymerase Chain Reaction |
| D005434 | Flow Cytometry |
| ID | Term |
|---|---|
| D007372 | Interferons |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D016215 | Macrophage-Activating Factors |
| D008222 | Lymphokines |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D021141 | Nucleic Acid Amplification Techniques |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003592 | Cytophotometry |
| D005470 | Fluorometry |
| D008163 | Luminescent Measurements |
| D010783 | Photometry |
| D002623 | Chemistry Techniques, Analytical |
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