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

Completed · Phase 1

Conditions studied: Refractory Multiple Myeloma, Stage I Multiple Myeloma, Stage II Multiple Myeloma, Stage III Multiple Myeloma

In brief

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

Key facts

Study ID

NCT00002787

Run by

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

People needed

22

Starts

1996-03-01

Last updated by the study team

2019-05-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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