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Interferon-gamma or Aldesleukin and Vaccine Therapy in Treating Patients With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00616720
Recruitment Status : Completed
First Posted : February 15, 2008
Last Update Posted : May 16, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Mayo Clinic

Study Description
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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.


Condition or disease Intervention/treatment Phase
Multiple Myeloma and Plasma Cell Neoplasm Biological: aldesleukin Biological: idiotype-pulsed autologous dendritic cell vaccine APC8020 Biological: recombinant interferon gamma Genetic: polymerase chain reaction Genetic: reverse transcriptase-polymerase chain reaction Other: flow cytometry Other: laboratory biomarker analysis Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Dendritic Cell-Based Idiotype Vaccination With Adjuvant Cytokines for Plateau Phase and Post-Transplant Multiple Myeloma
Study Start Date : August 2001
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Confirmed response (i.e., clinical or immunological)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616720


Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
Investigators
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Study Chair: Martha Q. Lacy, MD Mayo Clinic
More Information
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Responsible Party: Martha Q. Lacy, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00616720    
Other Study ID Numbers: CDR0000582566
P30CA015083 ( U.S. NIH Grant/Contract )
998003 ( Other Identifier: Mayo Clinic Cancer Center )
789-99 ( Other Identifier: Mayo Clinic IRB )
First Posted: February 15, 2008    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011
Keywords provided by Mayo Clinic:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
 Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Interferons
Aldesleukin
Interferon-gamma
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Anti-HIV Agents
Anti-Retroviral Agents