Interferon-gamma or Aldesleukin and Vaccine Therapy in Treating Patients With Multiple Myeloma
Primary Purpose
Multiple Myeloma and Plasma Cell Neoplasm
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
aldesleukin
idiotype-pulsed autologous dendritic cell vaccine APC8020
recombinant interferon gamma
polymerase chain reaction
reverse transcriptase-polymerase chain reaction
flow cytometry
laboratory biomarker analysis
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma and Plasma Cell Neoplasm focused on measuring stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
Eligibility Criteria
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:
- Quantifiable serum M protein
- Adequate serum sample stored in Transfusion Medicine under IRB protocol #698-98
- 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:
- ECOG performance status 0-2
- Life expectancy ≥ 6 months
- WBC ≥ 1,500/μL
- Platelet count ≥ 50,000/μL
- Total bilirubin ≤ 5 times upper limit of normal
- Creatinine ≤ 5.0 mg/dL
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Must have adequate venous access for apheresis
- No uncontrolled cardiac disease
- No uncontrolled infection
- No illness or condition which, in the opinion of the investigator, may affect safety of treatment or evaluation of any of the study's endpoints
PRIOR CONCURRENT THERAPY:
- Recovered from all prior therapy
- More than 4 weeks since prior standard-dose chemotherapy, radiotherapy, or immunotherapy
- More than 3 months since prior high-dose chemotherapy with stem cell transplantation
- No concurrent corticosteroids
Sites / Locations
Outcomes
Primary Outcome Measures
Confirmed response (i.e., clinical or immunological)
Secondary Outcome Measures
Full Information
NCT ID
NCT00616720
First Posted
February 14, 2008
Last Updated
May 13, 2011
Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00616720
Brief Title
Interferon-gamma or Aldesleukin and Vaccine Therapy in Treating Patients With Multiple Myeloma
Official Title
Randomized Phase II Trial of Dendritic Cell-Based Idiotype Vaccination With Adjuvant Cytokines for Plateau Phase and Post-Transplant Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mayo Clinic
Collaborators
National Cancer Institute (NCI)
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
OBJECTIVES:
Primary
To assess the clinical benefit in patients with plateau phase multiple myeloma treated with interferon-gamma vs aldesleukin in combination with idiotype-pulsed autologous dendritic cell vaccine APC8020.
To describe response rates in patients who are in plateau phase status post-chemotherapy or status post-peripheral blood cell transplantation treated with this regimen.
Secondary
To obtain data regarding the ability of this approach to produce an anti-idiotypic immunologic response.
To obtain information about the effects of interferon-gamma and aldesleukin on the number, function, and activation state of immune effector-cells including T-cells and B-cells.
To perform detailed analyses of lymphocyte phenotypes and T-cell repertoires before and after idiotype-pulsed autologous dendritic cell vaccine APC8020.
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.
Arm I: Patients receive interferon-gamma subcutaneously (SC) once daily on days 1-5, 15-20, and 29-34 and idiotype-pulsed autologous dendritic cell vaccine APC8020 IV over 30-minutes on days 2, 16, and 30.
Arm II: Patients receive aldesleukin SC once daily days 1-5, 15-20, and 29-34 and idiotype-pulsed autologous dendritic cell vaccine APC8020 as in arm I.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma and Plasma Cell Neoplasm
Keywords
stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
aldesleukin
Intervention Type
Biological
Intervention Name(s)
idiotype-pulsed autologous dendritic cell vaccine APC8020
Intervention Type
Biological
Intervention Name(s)
recombinant interferon gamma
Intervention Type
Genetic
Intervention Name(s)
polymerase chain reaction
Intervention Type
Genetic
Intervention Name(s)
reverse transcriptase-polymerase chain reaction
Intervention Type
Other
Intervention Name(s)
flow cytometry
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Primary Outcome Measure Information:
Title
Confirmed response (i.e., clinical or immunological)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Quantifiable serum M protein
Adequate serum sample stored in Transfusion Medicine under IRB protocol #698-98
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:
ECOG performance status 0-2
Life expectancy ≥ 6 months
WBC ≥ 1,500/μL
Platelet count ≥ 50,000/μL
Total bilirubin ≤ 5 times upper limit of normal
Creatinine ≤ 5.0 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Must have adequate venous access for apheresis
No uncontrolled cardiac disease
No uncontrolled infection
No illness or condition which, in the opinion of the investigator, may affect safety of treatment or evaluation of any of the study's endpoints
PRIOR CONCURRENT THERAPY:
Recovered from all prior therapy
More than 4 weeks since prior standard-dose chemotherapy, radiotherapy, or immunotherapy
More than 3 months since prior high-dose chemotherapy with stem cell transplantation
No concurrent corticosteroids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Q. Lacy, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
12. IPD Sharing Statement
Learn more about this trial
Interferon-gamma or Aldesleukin and Vaccine Therapy in Treating Patients With Multiple Myeloma
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