Bortezomib, Cyclophosphamide, and Dexamethasone in Treating Patients With Primary Systemic Light Chain Amyloidosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01072773
First received: February 17, 2010
Last updated: March 5, 2014
Last verified: March 2014
Results First Received: November 7, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Primary Systemic Amyloidosis
Interventions: Drug: bortezomib
Drug: cyclophosphamide
Drug: dexamethasone

  Participant Flow
  Hide Participant Flow

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
No text entered.

Reporting Groups
  Description
Bortez/Cyc/Dex Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.

Participant Flow:   Overall Study
    Bortez/Cyc/Dex  
STARTED     2  
COMPLETED     2  
NOT COMPLETED     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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
Bortez/Cyc/Dex Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.

Baseline Measures
    Bortez/Cyc/Dex  
Number of Participants  
[units: participants]
  2  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     0  
>=65 years     2  
Age  
[units: years]
Median ( Full Range )
  69  
  ( 67 to 71 )  
Gender  
[units: participants]
 
Female     2  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     2  
Prior Treatment [1]
[units: Prior┬áTreatments]
Mean ( Full Range )
  6.5  
  ( 1 to 11 )  
[1] Number of previous regimens used for the treatment of amyloidosis. There is no limit to the number of prior therapies provided there is adequate residual organ function.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With a Confirmed Hematologic Response   [ Time Frame: Duration of treatment (up to 12 cycles/months) ]

2.  Secondary:   Number of Participants With Treatment Related Adverse Events.   [ Time Frame: Duration on treatment (up to 12 cycles/months) ]

3.  Secondary:   Number of Participants With an Organ Response.   [ Time Frame: Duration on treatment (up to 12 cycles/months) ]

4.  Secondary:   Overall Survival   [ Time Frame: Duration of Study (up to 5 years) ]

5.  Secondary:   Time to Disease Progression   [ Time Frame: Duration of Study (up to 5 years) ]

6.  Secondary:   Duration of Response   [ Time Frame: Duration of Study (up to 5 years) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
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.  


Results Point of Contact:  
Name/Title: Dr. Shaji Kumar
Organization: Mayo Clinic
e-mail: kumar.shaji@mayo.edu


No publications provided


Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01072773     History of Changes
Other Study ID Numbers: MC0985, NCI-2009-01564, 09-005736, MC0985, X05306
Study First Received: February 17, 2010
Results First Received: November 7, 2012
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration