Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Novartis
Information provided by (Responsible Party):
Steven P. Treon, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00976248
First received: September 11, 2009
Last updated: June 11, 2014
Last verified: June 2014
Results First Received: June 13, 2013  
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
Intervention: Drug: RAD001

  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
RAD001

RAD001, oral, 10 mg, daily

RAD001 : Taken orally once a day


Participant Flow:   Overall Study
    RAD001  
STARTED     33  
COMPLETED     33  
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
RAD001

RAD001, oral, 10 mg, daily

RAD001 : Taken orally once a day


Baseline Measures
    RAD001  
Number of Participants  
[units: participants]
  33  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     21  
>=65 years     12  
Gender  
[units: participants]
 
Female     9  
Male     24  
Region of Enrollment  
[units: participants]
 
United States     33  



  Outcome Measures

1.  Primary:   Overall Response Rate of RAD001 in Patients With Previously Untreated WM   [ Time Frame: 2 years ]

2.  Primary:   Safety and Tolerability of RAD001 in Symptomatic Patients With Previously Untreated WM.   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Primary:   Time to Progression and Time to Next Therapy With Single Agent RAD001 Therapy in Previously Untreated WM.   [ Time Frame: 2 years ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  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
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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.


Results Point of Contact:  
Name/Title: Steven P. Treon, MD, PhD
Organization: Dana-Farber Cancer Institute
phone: 617-632-2681
e-mail: steven_treon@dfci.harvard.edu


No publications provided


Responsible Party: Steven P. Treon, MD, PhD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00976248     History of Changes
Other Study ID Numbers: 09-214
Study First Received: September 11, 2009
Results First Received: June 13, 2013
Last Updated: June 11, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration