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MAGE-A3 Protein + AS15 as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01380145
First Posted: June 27, 2011
Last Update Posted: December 22, 2016
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.
Collaborators:
GlaxoSmithKline
Mount Sinai Hospital, New York
New York University School of Medicine
Fox Chase Cancer Center
Memorial Sloan Kettering Cancer Center
Information provided by (Responsible Party):
Ludwig Institute for Cancer Research
Results First Submitted: September 7, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Biological: recMAGE-A3 Protein + AS15 Adjuvant

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
All Enrolled Subjects Subjects received a total of 8 pre- and post-auto-SCT immunizations with recMAGE-A3 + AS15 administered intramuscularly at a dose of 300 µg recMAGE-A3, with no dose adjustments permitted. The first immunization was administered 6 to 15 week prior to auto-SCT, with subsequent immunizations administered on Days 10, 31, 52, 73, and 94 (± 3 days) and Days 180 and 270 (± 7 days) after auto-SCT.

Participant Flow:   Overall Study
    All Enrolled Subjects
STARTED   13 
COMPLETED   9 
NOT COMPLETED   4 
Progressive disease                4 



  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.
Includes all subjects enrolled in the study.

Reporting Groups
  Description
All Enrolled Subjects Includes all subjects enrolled in the study.

Baseline Measures
   All Enrolled Subjects 
Overall Participants Analyzed 
[Units: Participants]
 13 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.3  (10.33) 
Gender 
[Units: Participants]
Count of Participants
 
Female      4  30.8% 
Male      9  69.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      12  92.3% 
Unknown or Not Reported      1   7.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      2  15.4% 
White      10  76.9% 
More than one race      0   0.0% 
Unknown or Not Reported      1   7.7% 
Region of Enrollment 
[Units: Participants]
 
United States   13 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.2  (4.74) 
Response to Prior Induction Therapy [1] 
[Units: Participants]
 
Complete Response   1 
Very Good Partial Response   12 
[1]

Complete Response (CR): negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, <5% plasma cells in bone marrow

Stringent CR (sCR): CR + normal free light chain (FLC) ratio and absence of clonal cells in bone marrow

Very Good Partial Response (VGPR): Serum/urine M-component detectable by immunofixation but not electropheresis OR ≥90% reduction in serum M-component + urine M-component <100 mg/24 hrs

PR: ≥50% reduction of serum M-protein and reduction in 24-hr urinary M-protein by ≥90% or to <200 mg/24 hrs

Stable disease: not response or progression



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Assessment of Safety of recMAGE-A3 + AS15   [ Time Frame: Continuously for up to 14 months ]

2.  Secondary:   Induction or Augmentation of MAGE-A3-Specific Humoral Immunity   [ Time Frame: Baseline, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT ]

3.  Secondary:   Induction or Augmentation of MAGE-A3-Specific Cellular Immunity   [ Time Frame: Baseline, first immunization, and first and second leukopheresis prior to auto-SCT; Days 31, 73, 194, 284, and 374 after auto-SCT ]

4.  Secondary:   Assessment of Tumor Response   [ Time Frame: At 3 and 12 months after auto-SCT ]

5.  Secondary:   Assessment of Survival and Time to Subsequent Therapy   [ Time Frame: Continuously on study and for up to 5 years post-study ]


  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:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Andrew Park, PharmD, Clinical Project Manager
Organization: Ludwig Institute for Cancer Research
phone: (212) 450-1587
e-mail: apark@licr.org



Responsible Party: Ludwig Institute for Cancer Research
ClinicalTrials.gov Identifier: NCT01380145     History of Changes
Other Study ID Numbers: LGS 2009-005
10-051 ( Other Identifier: Fox Chase Cancer Center )
10-216 ( Other Identifier: Memorial Sloan-Kettering Cancer Center )
First Submitted: June 20, 2011
First Posted: June 27, 2011
Results First Submitted: September 7, 2016
Results First Posted: December 22, 2016
Last Update Posted: December 22, 2016



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