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Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00298766
First received: March 1, 2006
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
Results First Received: July 16, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Amyloidosis
Intervention: Drug: VELCADE

  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
No text entered.

Reporting Groups
  Description
Single Agent VELCADE Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle

Participant Flow:   Overall Study
    Single Agent VELCADE  
STARTED     70  
COMPLETED     24  
NOT COMPLETED     46  
Adverse Event                 18  
Death                 2  
Withdrawal by Subject                 9  
Treatment ongoing                 4  
Progression of amyloid markers                 4  
Deterioration in KPS and organ function                 1  
Subjects overall condition deterioration                 4  
Other                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Single Agent VELCADE Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle

Baseline Measures
    Single Agent VELCADE  
Number of Participants  
[units: participants]
 		  70  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     43  
>=65 years     27  
Age  
[units: years]
Mean ± Standard Deviation 		  61  ± 10.10  
Gender  
[units: participants]
 		 
Female     31  
Male     39  
Region of Enrollment  
[units: participants]
 		 
United States     35  
Canada     8  
France     3  
Germany     11  
Italy     9  
Spain     4  



  Outcome Measures
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1.  Primary:   Maximum Tolerated Dose   [ Time Frame: 5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts ]
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2.  Primary:   Subjects With Treatment Emergent Adverse Events   [ Time Frame: from first study-related procedure to 30 days after last dose of study medication ]
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3.  Primary:   Subjects With Serious Treatment Emergent Adverse Events   [ Time Frame: from first study-related procedure to 30 days after last dose of study medication ]
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4.  Primary:   Subjects Grade 3/4/5 Treatment Emergent Adverse Events   [ Time Frame: from first study-related procedure to 30 days after last dose of study medication ]
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Measure Type Primary
Measure Title Subjects Grade 3/4/5 Treatment Emergent Adverse Events
Measure Description

Grade 3/4/5 treatment emergent adverse events observed during outcome measure time frame.

Grade is determined according to Common Terminology Criteria for Adverse Event (CTCAE) Version 3.0.
Time Frame from first study-related procedure to 30 days after last dose of study medication  
Safety Issue Yes  

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.
Safety population

Reporting Groups
  Description
Single Agent VELCADE Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle

Measured Values
    Single Agent VELCADE  
Number of Participants Analyzed  
[units: participants]
 		  70  
Subjects Grade 3/4/5 Treatment Emergent Adverse Events  
[units: participants]
 		  43  

No statistical analysis provided for Subjects Grade 3/4/5 Treatment Emergent Adverse Events



5.  Primary:   Subjects With Treatment Emergent Adverse Events Leading to Treatment Termination   [ Time Frame: from first study-related procedure to 30 days after last dose of study medication ]
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6.  Secondary:   Best Confirmed Hematologic Responders   [ Time Frame: from first dose of study medication to end of study visit ]
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  Serious Adverse Events
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  Other Adverse Events
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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 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.


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. Helgi van de Velde
Organization: Johnson & Johnson Pharmaceutical Research & Development
e-mail: HVDVELDE@ITS.JNJ.COM


No publications provided by Millennium Pharmaceuticals, Inc.

Publications automatically indexed to this study:


Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00298766     History of Changes
Other Study ID Numbers: 26866138-CAN-2007
Study First Received: March 1, 2006
Results First Received: July 16, 2010
Last Updated: June 19, 2012
Health Authority: United States: Food and Drug Administration