Vaccine Therapy in Treating Patients With Multiple Myeloma Who Have Undergone Stem Cell Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00002787
First received: November 1, 1999
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

The purpose of this trial is to test the safety and immune response to four immunizations with this vaccine made from a protein produced by the patient's tumor. There is no guarantee or promise that this procedure will be successful


Condition Intervention Phase
Refractory Multiple Myeloma
Stage I Multiple Myeloma
Stage II Multiple Myeloma
Stage III Multiple Myeloma
Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine
Biological: sargramostim
Biological: aldesleukin
Other: laboratory biomarker analysis
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial of Post Transplant Immunization With Autologous Myeloma Idiotype-KLH/GM-CSF In Myeloma Patients Following Autologous or Allogeneic Marrow or Stem Cell Transplantation

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]
    Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.

  • Immune response [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.


Estimated Enrollment: 40
Study Start Date: March 1996
Primary Completion Date: December 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (vaccine therapy)
Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim SC in weeks 0, 2, 6, and 10 and sargramostim SC QD for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14.
Biological: autologous immunoglobulin idiotype-KLH conjugate vaccine
Given SC
Other Names:
  • autologous immunoglobulin idiotype-keyhole limpet hemocyanin conjugate vaccine
  • GTOP-99
  • Id-KLH
  • Id-KLH conjugate vaccine
  • recombinant Id-KLH
Biological: sargramostim
Given SC
Other Names:
  • GM-CSF
  • Leukine
  • Prokine
Biological: aldesleukin
Given SC
Other Names:
  • IL-2
  • Proleukin
  • recombinant human interleukin-2
  • recombinant interleukin-2
Other: laboratory biomarker analysis
Correlative studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the safety of multiple subcutaneous vaccinations with myeloma Id-KLH (idiotype-keyhole limpet hemocyanin) with GM-CSF (sargramostim) in post allogeneic transplant myeloma patients, or with GM-CSF +/- interleukin (IL)-2 (aldesleukin) in post autologous transplant myeloma patients.

II. To evaluate patients pre and post bone marrow transplantation (BMT) for evidence of endogenous idiotype specific immune response.

III. To characterize the time course, specificity and persistence of antibody and T cell immune response to myeloma idiotype and to KLH induced by myeloma Ig (Id) immunization.

IV. To clone, expand and characterize T cells specific for the tumor idiotype. V. Monitor myeloma involvement in bone marrow and serum paraprotein level following vaccination.

VI. Use stored patient samples to clone, expand, and characterize T cells specific for myeloma antigens other than idiotype and identify the antigens they recognize so that they can be used in future studies.

OUTLINE:

Patients receive autologous immunoglobulin idiotype-KLH conjugate vaccine combined with sargramostim subcutaneously (SC) in weeks 0, 2, 6, and 10 and sargramostim SC once daily (QD) for three days following each vaccine injection. Some patients also receive aldesleukin SC daily from weeks 2-14.

After completion of study treatment, patients are followed up every 3 months for 1 year and then every 6 months for 1 year.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ELIGIBILITY FOR VACCINE PREPARATION:
  • Patients must have a diagnosis of multiple myeloma and be eligible for a Fred Hutchinson Cancer Research Center (FHCRC) treatment protocol using high dose therapy with syngeneic, allogeneic or autologous marrow or stem cell transplantation
  • Pretransplant sera available with immunoglobulin A (IgA), immunoglobulin D (IgD), immunoglobulin E (IgE), immunoglobulin G (IgG), or immunoglobulin M (IgM) monoclonal paraprotein with a level of 1.5 grams/dl or greater identifiable on serum protein electrophoresis; eligibility for patients with pretransplant paraprotein levels of less than 1.5 gm/dl will be evaluated on an individual basis to determine whether purification of idiotype is feasible
  • ELIGIBILITY FOR POST-TRANSPLANT IDIOTYPE VACCINATION:
  • Successful isolation and production of an autologous idiotype vaccine from pre-BMT sera
  • Greater than 60 days post BMT
  • Achievement of a partial remission or greater (more than 75% reduction in serum paraprotein) for patients transplanted in relapse
  • Stable absolute neutrophil count (ANC) > 1000
  • Platelet count > 50,000 not requiring transfusions or growth factors
  • Red blood cell (RBC) supportable to hematocrit (Hct) > 25 with less than 2 units of packed red blood cell (PRBC)/week
  • Treatment with a stable dose of Interferon is allowed
  • Karnofsky status > 60 percent
  • Immunosuppression:

    • Off all corticosteroids
    • Either off all immunosuppressive medications or on a stable/tapering dose of cyclosporin or FK506 only

Exclusion Criteria:

  • Graft-vs-host disease requiring treatment with corticosteroids
  • Serum creatinine > 3.0
  • Uncontrolled infection
  • Disease progression
  • Presence of medical complication that in the opinion of the investigators would result in inability to tolerate the vaccination protocol
  • Patients with a history of serious adverse reactions to GM-CSF
  • Patients with a history of serious adverse reactions to IL-2 will not receive concurrent IL-2 administration but may receive the Id-KLH vaccine with GM-CSF
  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: NCT00002787

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Investigators
Principal Investigator: David Maloney Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: Maloney, David, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier: NCT00002787     History of Changes
Other Study ID Numbers: 1104.00, NCI-2012-00669
Study First Received: November 1, 1999
Last Updated: May 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
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
Aldesleukin
Interleukin-2
Immunoglobulins
Antibodies
Immunoglobulin Idiotypes
Keyhole-limpet hemocyanin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Immunologic Factors

ClinicalTrials.gov processed this record on September 18, 2014