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Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma

NCT ID: NCT00116441

Last Updated: 2007-12-24

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-10-31

Study Completion Date

2004-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Multiple Myeloma

Keywords

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Multiple Myeloma Cancer PSCT Peripheral Stem Cell Transplant Chemotherapy GVAX

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Therapeutic Cellular Vaccine, GM-CSF Producing

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* No existing secondary malignancies and no history of secondary malignancies in the past 5 years
* No active autoimmune disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cell Genesys

INDUSTRY

Sponsor Role lead

Locations

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Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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K-0007

Identifier Type: -

Identifier Source: secondary_id

K-0007

Identifier Type: -

Identifier Source: org_study_id