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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


Phase 1
N/A
N/A
Open (Enrolling)
Both
Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicities graded using the National Cancer Institute (NCI) Common Toxicity Criteria

Outcome Description:

Descriptive statistics will be used to summarize changes from baseline in clinical laboratory parameters for each cohort.

Outcome Time Frame:

Up to 2 years

Safety Issue:

Yes

Principal Investigator

David Maloney

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Food and Drug Administration

Study ID:

1104.00

NCT ID:

NCT00002787

Start Date:

March 1996

Completion Date:

Related Keywords:

  • Refractory Multiple Myeloma
  • Stage I Multiple Myeloma
  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle, Washington  98109