NCT00116441

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of vaccination with autologous myeloma cells and an allogeneic granulocyte-macrophage colony stimulating factor (GM-CSF) producing cell line.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at P25-P50 for phase_1 multiple-myeloma

Timeline
Completed

Started Oct 2000

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

October 1, 2000

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 30, 2005

Completed
Last Updated

December 24, 2007

Status Verified

December 1, 2007

First QC Date

June 29, 2005

Last Update Submit

December 18, 2007

Conditions

Multiple Myeloma

Keywords

Multiple MyelomaCancerPSCTPeripheral Stem Cell TransplantChemotherapyGVAX

Outcome Measures

Primary Outcomes (1)

  • Multiple myeloma

Interventions

Therapeutic Cellular Vaccine, GM-CSF ProducingBIOLOGICAL

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • De novo multiple myeloma
  • ECOG 0-2
  • No serious co-morbid illnesses and adequate organ function
  • \> 4 weeks from systemic steroids

You may not qualify if:

  • No existing secondary malignancies and no history of secondary malignancies in the past 5 years
  • No active autoimmune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21231, United States

Location

MeSH Terms

Conditions

Multiple MyelomaNeoplasms

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 29, 2005

First Posted

June 30, 2005

Study Start

October 1, 2000

Study Completion

October 1, 2004

Last Updated

December 24, 2007

Record last verified: 2007-12

Locations

US(1)