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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00616720
First received: February 14, 2008
Last updated: May 13, 2011
Last verified: May 2011
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Confirmed response (i.e., clinical or immunological) [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: August 2001
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00616720

Sponsors and Collaborators
Mayo Clinic
Investigators
Study Chair: Martha Q. Lacy, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Martha Q. Lacy, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00616720     History of Changes
Other Study ID Numbers: CDR0000582566, P30CA015083, 998003, 789-99
Study First Received: February 14, 2008
Last Updated: May 13, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Additional relevant MeSH terms:
Neoplasms
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Immunoglobulin Idiotypes
Interferon-gamma
Interferons
Aldesleukin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Antineoplastic Agents
Anti-HIV Agents
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on September 14, 2014