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Human Immune Globulin in Treating Patients With Primary Amyloidosis That is Causing Heart Dysfunction

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00547365
First Posted: October 22, 2007
Last Update Posted: September 19, 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):
Alan Solomon, University of Tennessee
Results First Submitted: February 4, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Multiple Myeloma
Plasma Cell Neoplasm
Intervention: Biological: Human immune globulin intravenous (IGIV)

  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
Overall study length - 2007-2011; Location - medical clinic

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients with primary light-chain (AL)-associated amyloidosis that caused heart dysfunction were on study.

Reporting Groups
  Description
Human Immune Globulin Intravenous (IGIV) The therapeutic potential of human immune globulin intravenous (IGIV)was evaluated in patients with cardiac-associated AL amyloidosis. Patients received, via intravenous infusion, 30-40 gm of IGIV (depending on body weight) weekly for 3 months and then every other week for the next 9 months.The total time to complete the study was ~1 yr.

Participant Flow:   Overall Study
    Human Immune Globulin Intravenous (IGIV)
STARTED   10 
COMPLETED   2 
NOT COMPLETED   8 
Physician Decision                1 
Lost to Follow-up                1 
Protocol Violation                2 
death (not related to study)                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.
Patients with cardiac-dominant AL amyloidosis, as determined from standard clinical tests (IVS, BNP),were entered on study.

Reporting Groups
  Description
Human Immune Globulin Intravenous (IGIV) No text entered.

Baseline Measures
   Human Immune Globulin Intravenous (IGIV) 
Overall Participants Analyzed 
[Units: Participants]
 10 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   4 
>=65 years   6 
Gender 
[Units: Participants]
 
Female   5 
Male   5 
Region of Enrollment 
[Units: Participants]
 
United States   10 


  Outcome Measures
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1.  Primary:   Tolerance for Human Immune Globulin Intravenous (IGIV), as Reflected by the Number and Severity of Toxicity Incidents Occurring in Ten Patients Receiving at Least One Infusion of IGIV.   [ Time Frame: Up to 1 year ]

2.  Primary:   Clinical Response of Patients With Cardiac-dominant AL Amyloidosis Given Human Immune Globulin Intravenous (IGIV)   [ Time Frame: Up to 1 year ]


  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
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Alan Solomon, MD
Organization: University of Tennessee Graduate School of Medicine
phone: 865-305-9167
e-mail: asolomon@utmck.edu



Responsible Party: Alan Solomon, University of Tennessee
ClinicalTrials.gov Identifier: NCT00547365     History of Changes
Other Study ID Numbers: CDR0000572104
BRCC-BHS-06127 ( Other Identifier: Baxter )
UTCI-2645 ( Other Identifier: Baxter )
First Submitted: October 19, 2007
First Posted: October 22, 2007
Results First Submitted: February 4, 2013
Results First Posted: September 19, 2013
Last Update Posted: September 19, 2013