NCT00083538

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 multiple-myeloma

Timeline
Completed

Started Feb 2001

Typical duration for phase_2 multiple-myeloma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2004

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 27, 2004

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

July 7, 2010

Status Verified

July 1, 2010

Enrollment Period

6.8 years

First QC Date

May 25, 2004

Last Update Submit

July 6, 2010

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaDTPACEDexamethasoneThalidomideCisplatinCytoxanDoxorubicinEtoposideDendritic Cell VaccinationLeukapheresis

Outcome Measures

Primary Outcomes (1)

  • To determine if vaccination with autologous idiotype- or tumor lysate-pulsed dendritic cells induces the generation of anti-idiotypic and anti-tumor immunologic responses.

    24 months

Interventions

DexamethasoneDRUG
ThalidomideDRUG
CisplatinumDRUG
AdriamycinDRUG
CyclophosphamideDRUG
EtoposideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences/MIRT

Little Rock, Arkansas, 72205, United States

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

DexamethasoneThalidomideCisplatinDoxorubicinCyclophosphamideEtoposide

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedPhthalimidesPhthalic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidonesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIsoindolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsAminoglycosidesGlycosidesCarbohydratesPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesGlucosides

Study Officials

  • Van Rhee Frits, M.D.

    UAMS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 25, 2004

First Posted

May 27, 2004

Study Start

February 1, 2001

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

July 7, 2010

Record last verified: 2010-07

Locations

US(1)