Overview

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

Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Arkansas
Treatments:
BB 1101
Cisplatin
Cyclophosphamide
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Etoposide
Etoposide phosphate
Liposomal doxorubicin
Thalidomide
Vaccines
Criteria
Inclusion Criteria:

- 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

Exclusion Criteria:

- 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