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Study of MAGE-A3 and NY-ESO-1 Immunotherapy in Combo With DTPACE Chemo and Auto Transplantation in Multiple Myeloma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00090493
First Posted: August 31, 2004
Last Update Posted: June 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Arkansas
Results First Submitted: January 25, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Interventions: Biological: MAGE-A3
Biological: MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All patients of the Myeloma Institute who have “high-risk” multiple myeloma because of abnormalities in their cytogenetics, could participate in this study at UAMS only. Final IRB approval was 6/14/04. The 1st participant was enrolled 4/4/05.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Pre-study: hemogram, blood chemistry, Helper/Suppressor Panel, Immunoknow count, serum protein electrophoresis and immunofixation , serum freelites, 24-hr urine (protein and immunofixation), quantitation of immunoglobulins, B2M, IL6, bone marrow aspiration and biopsy, MRI, bone marrow collection for gene-array.

Reporting Groups
  Description
MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY

Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.

MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.

MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating.


Participant Flow:   Overall Study
    MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY
STARTED   4 
COMPLETED   2 
NOT COMPLETED   2 
Physician Decision                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY Treatment will consist of receiving peptide (small pieces of proteins) vaccinations as a shot just under the skin (subcutaneous). Purpose is to generate anti-myeloma T-cells with will kill only myeloma cells. Three injections of peptide will be given subcutaneously together with the adjuvant GM-CSF at 2-week intervals.

Baseline Measures
   MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY 
Overall Participants Analyzed 
[Units: Participants]
 4 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   2 
>=65 years   2 
Gender 
[Units: Participants]
 
Female   2 
Male   2 
Region of Enrollment 
[Units: Participants]
 
United States   4 


  Outcome Measures

1.  Primary:   The Number of Participants Experiencing a Response to the Peptide Vaccines.   [ Time Frame: 2 week intervals ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Frits van Rhee, MD, PhD
Organization: University of Arkansas for Medical Sciences - MIRT
phone: (501) 686-8230
e-mail: vanrheefrits@uams.edu



Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00090493     History of Changes
Other Study ID Numbers: UARK 2003-26
First Submitted: August 26, 2004
First Posted: August 31, 2004
Results First Submitted: January 25, 2013
Results First Posted: June 24, 2013
Last Update Posted: June 24, 2013