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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2007-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dendritic Cells(DC)-Based Id Vaccination in Stage-I Myeloma

NCT00988312

Multiple Myeloma Plasmocytoma

COMPLETED PHASE1

CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

NCT01995708

Multiple Myeloma

COMPLETED PHASE1

Dendritic Cell Based Therapy of Malignant Melanoma

NCT00197912

Advanced Melanoma

COMPLETED PHASE1/PHASE2

Dendritic Cells Plus Autologous Tumor RNA in Uveal Melanoma

NCT01983748

Uveal Melanoma

COMPLETED PHASE3

Single-step Antigen Loading and TLR Activation of Dendritic Cells in Melanoma Patients

NCT01530698

Melanoma

COMPLETED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an experimental treatment that will consist of receiving special white blood cell administrations either underneath the skin or in the lymph nodes. In this protocol, treatment will be given according to the "risk group". If there are certain abnormalities in the chromosomes, the disease is considered to be high risk. High-risk patients will first receive one cycle of chemotherapy with a regimen called DT PACE, after which the white blood cells will be collected. Leukapheresis is a procedure in which blood is removed, white blood cells are saved, and the remaining blood is given back to you. These dendritic cells will then be mixed with your individual myeloma protein and/or cells, and keyhole limpet hemocyanin (KLH) that is necessary for the enhancement of immune response against myeloma antigens. It is hoped that this will cause these cells to interact with and activate T cells, which will then destroy myeloma cells in your body. Half of these white cells will be injected into your lymph nodes (intranodally) and half will be given subcutaneously. High risk patients will receive a chemotherapy regimen called DT PACE.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Myeloma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexamethasone

Intervention Type DRUG

Thalidomide

Intervention Type DRUG

Cisplatinum

Intervention Type DRUG

Adriamycin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Etoposide

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No