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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: December 14, 2016
Last verified: December 2016
Results First Received: June 13, 2013  
Study Type: Interventional
Study Design: 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.
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Reporting Groups
  Description
RAD001

RAD001, oral, 10 mg, daily

RAD001 : Taken orally once a day


Baseline Measures
   RAD001 
Overall Participants Analyzed 
[Units: Participants]
 33 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      21  63.6% 
>=65 years      12  36.4% 
Gender 
[Units: Participants]
Count of Participants
 
Female      9  27.3% 
Male      24  72.7% 
Region of Enrollment 
[Units: Participants]
 
United States   33 


  Outcome Measures
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1.  Primary:   Overall Response Rate of RAD001 in Patients With Previously Untreated WM   [ Time Frame: End of Treatment ]

2.  Primary:   Time to Progression With Single Agent RAD001 Therapy in Previously Untreated WM.   [ Time Frame: End of Treatment ]

3.  Primary:   Time to Next Therapy With Single Agent RAD001 Therapy in Previously Untreated WM   [ Time Frame: End of follow-up ]


  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


Publications of Results:
Treon SP, Tripsas CK, Ioakimidis L, Warren D, Patterson C, Heffner L, Eradat H, Gregory SA, Thomas S, Advani R, Baz R, Badros, Ashraf Z, Matous J, Anderson KC, Ghobrial IM Prospective, Multicenter Study of the MTOR Inhibitor Everolimus (RAD001) As Primary Therapy in Waldenstrom's Macroglobulinemia ASH Annual Meeting Abstracts 2011 118: 2951
Treon SP, Tripsas CK, Meid K, Patterson CJ, Heffner H, Gregory SA, Thomas SK, Advani RH, Baz R, Badros AZ, Matous J, Murphy TJ, Ghobrial IM. Prospective, Multicenter Study Of The MTOR Inhibitor Everolimus (RAD001) As Primary Therapy In Waldenstrom's Macroglobulinemia Blood 2013 122:1822.


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: December 14, 2016