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Combination Bortezomib and Rituximab in Patients With Waldenstrom's Macroglobulinemia

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.
ClinicalTrials.gov Identifier: NCT00422799
Recruitment Status : Completed
First Posted : January 17, 2007
Results First Posted : January 26, 2018
Last Update Posted : January 26, 2018
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Irene Ghobrial, MD, Dana-Farber Cancer Institute

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Waldenstrom's Macroglobulinemia
Interventions: Drug: Bortezomib
Drug: Rituximab

  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
Bortezomib and Rituximab

bortezomib and rituximab

Bortezomib: Once weekly for 3 weeks

Rituximab: Intravenously once a week for the first and fourth weeks of a cycle


Participant Flow:   Overall Study
    Bortezomib and Rituximab
STARTED   63 
COMPLETED   50 
NOT COMPLETED   13 
Withdrawal by Subject                6 
Adverse Event                7 



  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
Bortezomib and Rituximab

bortezomib and rituximab

Bortezomib: Once weekly for 3 weeks

Rituximab: Intravenously once a week for the first and fourth weeks of a cycle


Baseline Measures
   Bortezomib and Rituximab 
Overall Participants Analyzed 
[Units: Participants]
 63 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      36  57.1% 
>=65 years      27  42.9% 
Age 
[Units: Years]
Median (Full Range)
 63 
 (43 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      22  34.9% 
Male      41  65.1% 
Region of Enrollment 
[Units: Participants]
 
United States   63 


  Outcome Measures

1.  Primary:   Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Relapsed or Refractory WM.   [ Time Frame: 2 Years ]

2.  Primary:   Overall Response Rate of Bortezomib and Rituximab (VR) in Patients With Previously Untreated WM   [ Time Frame: 2 years ]

3.  Secondary:   Time to Progression in Patients With WM   [ Time Frame: 5 Years ]

4.  Secondary:   Duration of Response in Patients With WM   [ Time Frame: 5 Years ]


  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 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Irene M. Ghobrial
Organization: Dana-Farber Cancer Institute
phone: (617) 632-4218
e-mail: Irene_Ghobrial@DFCI.HARVARD.EDU


Publications of Results:

Responsible Party: Irene Ghobrial, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00422799     History of Changes
Other Study ID Numbers: 06-008
First Submitted: January 12, 2007
First Posted: January 17, 2007
Results First Submitted: December 27, 2017
Results First Posted: January 26, 2018
Last Update Posted: January 26, 2018