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Bortezomib and Lenalidomide in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00553644
First Posted: November 5, 2007
Last Update Posted: August 10, 2017
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.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: January 6, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Recurrent Mantle Cell Lymphoma
Interventions: Drug: Bortezomib
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide

  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
Between November 2007 and July 2011, 54 participants were recruited to this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One participant was deemed ineligible and removed for all analyses; therefore, 53 participants were analyzed.

Reporting Groups
  Description
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)

Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.

bortezomib: Given IV

lenalidomide: Given PO


Participant Flow:   Overall Study
    Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)
STARTED   53 
COMPLETED   25 
NOT COMPLETED   28 
Adverse Event                17 
Withdrawal by Subject                4 
Physician Decision                1 
Alternative therapy                6 



  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
Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)

Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.

bortezomib: Given IV

lenalidomide: Given PO


Baseline Measures
   Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy) 
Overall Participants Analyzed 
[Units: Participants]
 53 
Age 
[Units: Years]
Median (Full Range)
 67 
 (39 to 83) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      9  17.0% 
Male      44  83.0% 
Region of Enrollment 
[Units: Participants]
 
United States   53 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With an Overall Response Defined as Complete Response and Partial Response   [ Time Frame: Duration of treatment (assessed up to 6 years) ]

2.  Secondary:   Incidence of Adverse Events   [ Time Frame: Duration of Treatment (up to 6 years) ]

3.  Secondary:   Time to Progression   [ Time Frame: Assessed up to 6 years ]

4.  Secondary:   Overall Survival   [ Time Frame: Assessed up to 6 years ]


  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
No text entered.


  More Information
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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: Vicki Morrison, M.D.
Organization: Veterans Affairs Medical Center/University of Minnesota
e-mail: morri002@umn.edu



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00553644     History of Changes
Other Study ID Numbers: NCI-2009-00483
NCI-2009-00483 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000573827
CALGB 50501 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-50501 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: November 2, 2007
First Posted: November 5, 2007
Results First Submitted: January 6, 2014
Results First Posted: February 20, 2014
Last Update Posted: August 10, 2017