CC-5013 (Lenalidomide) and Rituximab in Waldenstrom's Macroglobulinemia

This study has been terminated.
(Toxicity)
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Celgene Corporation
Genentech, Inc.
Information provided by (Responsible Party):
Steven P. Treon, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00142168
First received: September 1, 2005
Last updated: November 11, 2015
Last verified: November 2015
Results First Received: December 19, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Waldenstrom's Macroglobulinemia
Interventions: Drug: CC-5103 (lenalidomide)
Drug: Rituximab

  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
Outpatient clinic at DFCI

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Symptomatic WM patients requiring therapy

Reporting Groups
  Description
Lenalidomide and Rituximab Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.

Participant Flow:   Overall Study
    Lenalidomide and Rituximab  
STARTED     16  
COMPLETED     16  
NOT COMPLETED     0  



  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.
No text entered.

Reporting Groups
  Description
Lenalidomide and Rituximab Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.

Baseline Measures
    Lenalidomide and Rituximab  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     10  
>=65 years     6  
Age  
[units: years]
Mean (Standard Deviation)
  59  (9)  
Gender  
[units: participants]
 
Female     4  
Male     12  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Time to Progression   [ Time Frame: 34.3 months ]

2.  Primary:   Overall Response   [ Time Frame: 34.3 months ]

3.  Secondary:   Major Response Rate   [ Time Frame: 34.3 months ]

4.  Secondary:   Minor Response Rate   [ Time Frame: 34.3 months ]


  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
Due to toxicity, study was terminated.


  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: Steven P. Treon MD PhD
Organization: DFCI
phone: 617 632 2681
e-mail: steven_treon@dfci.harvard.edu


Publications of Results:

Responsible Party: Steven P. Treon, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00142168     History of Changes
Other Study ID Numbers: 04-158
Study First Received: September 1, 2005
Results First Received: December 19, 2012
Last Updated: November 11, 2015
Health Authority: United States: Food and Drug Administration