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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alan Solomon, University of Tennessee
ClinicalTrials.gov Identifier:
NCT00547365
First received: October 19, 2007
Last updated: September 16, 2013
Last verified: September 2013
Results First Received: February 4, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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)  
Number of Participants  
[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


No publications provided


Responsible Party: Alan Solomon, University of Tennessee
ClinicalTrials.gov Identifier: NCT00547365     History of Changes
Other Study ID Numbers: CDR0000572104, BRCC-BHS-06127, UTCI-2645
Study First Received: October 19, 2007
Results First Received: February 4, 2013
Last Updated: September 16, 2013
Health Authority: United States: Institutional Review Board