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Phase II Study of Autologous Myeloma-Derived Immunoglobulin Idiotype Conjugated to Keyhole Limpet Hemocyanin Plus Sargramostim (GM-CSF) in Patients With Multiple Myeloma Undergoing Second Autologous Peripheral Blood Stem Cell Transplantation


Phase 2
18 Years
N/A
Not Enrolling
Both
Stage II Multiple Myeloma, Stage III Multiple Myeloma, Refractory Plasma Cell Neoplasm

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Trial Information

Phase II Study of Autologous Myeloma-Derived Immunoglobulin Idiotype Conjugated to Keyhole Limpet Hemocyanin Plus Sargramostim (GM-CSF) in Patients With Multiple Myeloma Undergoing Second Autologous Peripheral Blood Stem Cell Transplantation


OBJECTIVES: I. Determine whether autologous myeloma-derived immunoglobulin idiotype
conjugated to keyhole limpet hemocyanin plus sargramostim (GM-CSF) can induce cellular and
humoral immunity against the unique idiotype expressed on the surface of myeloma cells in
patients with multiple myeloma undergoing second autologous peripheral blood stem cell
transplantation.

II. Determine the clinical efficacy and safety of this regimen in these patients.

PROTOCOL OUTLINE: Within 6 months after the first autologous peripheral blood stem cell
transplantation (APBSCT), patients receive melphalan IV over 30 minutes on day -2 and the
second APBSCT on day 0. Sargramostim (GM-CSF) is administered subcutaneously (SC) beginning
on day 1 and continuing until blood counts recover. Patients are also assigned to 1 of 3
vaccination groups.

Group 1: Patients receive autologous myeloma-derived immunoglobulin idiotype conjugated to
keyhole limpet hemocyanin (Id-KLH) SC on day 1 and GM-CSF SC on days 1-4 of months 2, 3, and
5 after the second APBSCT for a total of 3 vaccinations.

Group 2: Patients receive Id-KLH SC on day 1 and GM-CSF SC on days 1-4 of months 2, 3, 4, 5,
6, and 8 after the second APBSCT for a total of 6 vaccinations.

Group 3: Patients receive Id-KLH SC on day 1 and GM-CSF SC on days 1-4 of weeks -8, -6, and
-2 before and months 2, 3, and 5 after the second APBSCT for a total of 6 vaccinations.

Patients are followed within 3 months and then every 6 months.

PROJECTED ACCRUAL:

A maximum of 60 patients (20 per treatment group) will be accrued for this study within 3
years.

Inclusion Criteria


PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Immunoglobulin G or immunoglobulin A (IgA) multiple myeloma
Low or intermediate risk disease based on the following criteria: Cytogenetics: no
translocations, 11q, or -13/13q- Beta-2 microglobulin less than 2.5 mg/L before the first
autologous peripheral blood stem cell transplantation (APBSCT) M-protein concentration in
harvested plasma greater than 50% of total immunoglobulin of corresponding isotype
(M-protein must be able to be purified by protein A- or anti-IgA-sepharose) Patients
achieving partial or complete response after the first APBSCT eligible --Prior/Concurrent
Therapy-- Biologic therapy: See Disease Characteristics No prior APBSCT with CD34 selected
stem cells Chemotherapy: Not specified Endocrine therapy: Steroids must be discontinued at
least 4 weeks prior to vaccination No concurrent steroids Radiotherapy: Not specified
Surgery: Not specified Other: Any prior therapy must be completed at least 8 weeks prior
to second APBSCT Recovered from the toxic effects of prior therapy No concurrent aspirin
or nonsteroidal antiinflammatory drugs --Patient Characteristics-- Age: 18 and over
Performance status: Karnofsky 70-100% Life expectancy: More than 8 weeks Hepatic:
Bilirubin less than 2.0 mg/dL and not rising for at least 2-4 weeks before transplantation
SGOT no greater than 4 times upper limit of normal and not rising for at least 2-4 weeks
before transplantation Renal: Creatinine less than 2 times normal and not rising for at
least 2-4 weeks before transplantation OR Creatinine clearance greater than 40 mL/min
Cardiovascular: LVEF greater than 50% by MUGA scan Pulmonary: DLCO greater than 50%
predicted Other: No other medical condition that would increase risk of transplantation
HIV negative Not pregnant or nursing Negative pregnancy test Fertile patients must use
effective contraception

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Larry W. Kwak

Investigator Role:

Study Chair

Investigator Affiliation:

National Cancer Institute (NCI)

Authority:

United States: Federal Government

Study ID:

CDR0000064244

NCT ID:

NCT00019097

Start Date:

July 1995

Completion Date:

March 2007

Related Keywords:

  • Stage II Multiple Myeloma
  • Stage III Multiple Myeloma
  • Refractory Plasma Cell Neoplasm
  • body system/site cancer
  • cancer
  • genetic condition
  • hematopoietic/lymphoid cancer
  • multiple myeloma
  • multiple myeloma and other plasma cell neoplasms
  • plasma cell neoplasm
  • refractory plasma cell neoplasm
  • stage II multiple myeloma
  • stage III multiple myeloma
  • stage, plasma cell neoplasm
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma

Name

Location

University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Medicine BranchBethesda, Maryland  20892
Arkansas Cancer Research CenterLittle Rock, Arkansas  72205