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Oral Lenalidomide and Intravesical BCG for Therapy of Bladder Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01373294
First received: June 13, 2011
Last updated: September 1, 2016
Last verified: September 2016
Results First Received: December 28, 2015  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Bladder Cancer
Interventions: Drug: Bacille Calmette-Guerrin (BCG)
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
Moffitt Cancer Center recruited participants between November 2011 and September 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer.

Reporting Groups
  Description
A: Combination Arm Bacille Calmette-Guerrin (BCG) and lenalidomide.
B: Control Arm Bacille Calmette-Guerrin (BCG).

Participant Flow:   Overall Study
    A: Combination Arm   B: Control Arm
STARTED   15   2 
COMPLETED   14   2 
NOT COMPLETED   1   0 
Adverse Event                1                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.
The Primary Outcome Measure addresses Arm A only, whose participants received the experimental drug. Too few participants were enrolled into Arm B to conduct the planned per arm comparison. Demographic details and Adverse Events have been reported for all participants in both arms.

Reporting Groups
  Description
A: Combination Arm Bacille Calmette-Guerrin (BCG) and lenalidomide.
B: Control Arm Bacille Calmette-Guerrin (BCG).
Total Total of all reporting groups

Baseline Measures
   A: Combination Arm   B: Control Arm   Total 
Overall Participants Analyzed 
[Units: Participants]
 15   2   17 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   3   0   3 
>=65 years   12   2   14 
Age 
[Units: Years]
Mean (Full Range)
 72 
 (52 to 85) 
 70 
 (66 to 74) 
 71.8 
 (52 to 85) 
Gender 
[Units: Participants]
     
Female   1   0   1 
Male   14   2   16 
Region of Enrollment 
[Units: Participants]
     
United States   15   2   17 


  Outcome Measures
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1.  Primary:   Arm A: Progression Free Survival (PFS)   [ Time Frame: 1 year ]

2.  Secondary:   Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)   [ Time Frame: Duration of study treatment and follow-up - average of 12 months ]

3.  Other Pre-specified:   Effect of Addition of Revlimid on Cytokines   [ Time Frame: Duration of study treatment and follow-up - average of 12 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Other Pre-specified:   Comparison of the Correlative Assay   [ Time Frame: 1 year post disease response ]
Results not yet reported.   Anticipated Reporting 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
This study closed to accrual early, due to slow accrual. Too few participants were enrolled into Arm B to conduct the planned per arm comparisons.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Mayer Fishman
Organization: H. Lee Moffitt Cancer Center and Research Institute
phone: 813-745-8311
e-mail: mayer.fishman@moffitt.org



Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT01373294     History of Changes
Other Study ID Numbers: MCC-16295
RV-BLD-PI-0330 ( Other Identifier: Celgene Corp. )
Study First Received: June 13, 2011
Results First Received: December 28, 2015
Last Updated: September 1, 2016
Health Authority: United States: Food and Drug Administration