Study of Tumor Antigen-Pulsed Autologous Dendritic Cell Vaccination Administrated Subcutaneously or Intranodally

Completed · Phase 2

Conditions studied: Multiple Myeloma

In brief

The purpose of this study is to determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses.

Key facts

Study ID

NCT00083538

Run by

University of Arkansas

People needed

40

Starts

2001-02-01

Expected to finish

2007-12-01

Last updated by the study team

2010-07-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have confirmed diagnosis of one of the following: Smoldering or indolent multiple myeloma, Multiple myeloma more than 1 year after autologous transplant and with stable disease, or Multiple myeloma with cytogenetic abnormalities
• Patients with secretory IgA or IgG must have purified idiotype protein available and/or tumor cells available, and patients with light chain or non-secretory myeloma must have tumor cells available
• Karnofsky performance score greater than or equal to 60
• ANC greater than or equal to 1,000/microliters, platelet count greater than or equal to 60,000/microliters, and CD4 count greater than or equal to 400/microliters.
• Expected survival of 3 months or more
• 18 years of age and older
• Have given a written consent and been informed about the investigational nature of the study.
• Negative serology for HIV, Hepatitis C, and negative for hepatitis B surface antigen

You may not qualify if…

• Patients with CD4 count < 400/microliters, and/or with severely damaged immune functions
• Chemotherapy or other immunosuppressive treatment with steroids, cytoxan, methotrexate within 8 weeks
• Fever or active infection
• Liver function: total bilirubin greater than or equal to 2 x ULN or AST/ALT greater than or equal to 3 x ULN
• Renal function: Patients on dialysis
• Simultaneous treatment with a second investigational drug or biologic agent

Where it is running

• University of Arkansas for Medical Sciences/MIRT — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.