RATIONALE: Vaccines may make the body build an immune response to and kill tumor cells. Colony-stimulating factors such as GM-CSF increase the number of immune cells found in bone marrow or peripheral blood. PURPOSE: Phase I trial to study the effectiveness of vaccine therapy plus GM-CSF in treating patients with multiple myeloma undergoing bone marrow or peripheral stem cell transplantation.

Condition	Treatment or Intervention	Phase
stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma	Drug: keyhole limpet hemocyanin  Drug: sargramostim	Phase I

Further Study Details: 

OBJECTIVES: I. Determine the safety of multiple subcutaneous vaccination with myeloma Id-KLH with adjuvant sargramostim (GM-CSF) in posttransplant myeloma patients. II. Evaluate patients' pre- and post-bone marrow transplants for evidence of endogenous idiotype specific immune response. III. 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. Clone, expand, and characterize T cell clones specific for the tumor idiotype. V. Monitor myeloma involvement in bone marrow and serum paraprotein level following vaccination.

PROTOCOL OUTLINE: Patients more than 60 days posttransplant are vaccinated with autologous idiotype vaccine at 0, 2, 6, and 10 weeks. Allogeneic recipients are vaccinated after they are off corticosteroids and on a stable or tapering dose of cyclosporine or tacrolimus (FK506). A series of 4 subcutaneous injections of autologous Id-KLH is given with 3 additional daily injections of GM-CSF subcutaneously at the same site.

PROJECTED ACCRUAL: 35-40 patients will be entered.

Ages Eligible for Study:  18 Years   -   65 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically proven multiple myeloma of late stage B cells
• Eligible for a FHCRC protocol using high dose therapy with syngeneic, allogeneic, or autologous marrow or stem cell transplantation
• Achievement of partial or greater remission for patients transplanted in relapse

--Prior/Concurrent Therapy--

• No concurrent posttransplant immunomodulation with IL-2

--Patient Characteristics--

• Age: 18 to 65
• Performance status: Karnokfsky 60-100%
• Life expectancy: Not specified
• Hematopoietic: Absolute neutrophil count greater than 1000/mm3; Platelet count greater than 50,000/mm3 without transfusions or growth factors; RBC supportable to hematocrit greater than 25 with less than 2 units of packed RBC/week
• Hepatic: Not specified
• Renal: Creatinine no greater than 3.0 mg/dL
• Other: Must have pretransplant sera available with IgG, IgA, or IgM monoclonal paraprotein with a level of 1.5 g/dL or greater identifiable on serum protein electrophoresis; Successful isolation and production of an autologous idiotype vaccine from pre-BMT sera; Must be off corticosteroids prior to vaccination; No infections; No disease progression after transplant; No graft versus host disease (GVHD) at vaccination; No medical conditions that would result in inability to tolerate the vaccination; No prior history of serious adverse reactions to GM-CSF

Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109,  United States

Study chairs or principal investigators

David G. Maloney,  Study Chair,  Fred Hutchinson Cancer Research Center   

Study ID Numbers:  CDR0000064851; FHCRC-1104.00; NCI-H96-0924
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002787
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08