Vaccination in the Peripheral Stem Cell Transplant Settin... | NCT00116441

Studies
Vaccination in the Peripheral Stem Cell Transplant Setting for Multiple Myeloma

NCT00116441

Sponsor

Cell Genesys

Status

Completed

Last Update Posted

Dec 24, 2007Estimated

Enrollment

Phase

Phase 1Phase 2

Conditions

Multiple Myeloma

Interventions

Therapeutic Cellular Vaccine, GM-CSF Producing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
K-0007

Status Module

Record Verification Date

Dec 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Oct 2000

Primary Completion Date

Not provided

Completion Date

Oct 2004

First Submitted Date

Jun 29, 2005

First Submission Date that Met QC Criteria

Jun 29, 2005

First Posted Date

Jun 30, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 18, 2007

Last Update Posted Date

Dec 24, 2007Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Therapeutic Cellular Vaccine, GM-CSF Producing	Biological

Measure	Description	Time Frame
Multiple myeloma

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Johns Hopkins University		Baltimore	Maryland	21231	United States

Condition Browse Module

MeSH Terms

ID	Term
D009101	Multiple Myeloma
D009369	Neoplasms

Ancestor Terms

ID	Term
D054219	Neoplasms, Plasma Cell
D009370	Neoplasms by Histologic Type
D020141	Hemostatic Disorders
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided