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Trial record 1 of 1 for:    21562045 [PUBMED-IDS]
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Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis

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ClinicalTrials.gov Identifier: NCT00298766
Recruitment Status : Completed
First Posted : March 3, 2006
Results First Posted : August 13, 2010
Last Update Posted : June 25, 2012
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Amyloidosis
Intervention: Drug: VELCADE

  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
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

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
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 
Overall Participants Analyzed 
[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

1.  Primary:   Maximum Tolerated Dose   [ Time Frame: 5 weeks in once weekly (QW) dose cohorts and 3 weeks in twice weekly (BIW) dose cohorts ]

2.  Primary:   Subjects With Treatment Emergent Adverse Events   [ Time Frame: from first study-related procedure to 30 days after last dose of study medication ]

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 ]

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 ]

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 ]

6.  Secondary:   Best Confirmed Hematologic Responders   [ Time Frame: from first dose of study medication to end of study visit ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00298766     History of Changes
Other Study ID Numbers: 26866138-CAN-2007
First Submitted: March 1, 2006
First Posted: March 3, 2006
Results First Submitted: July 16, 2010
Results First Posted: August 13, 2010
Last Update Posted: June 25, 2012