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Oral Lenalidomide and Intravesical BCG for Therapy of Bladder Cancer

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ClinicalTrials.gov Identifier: NCT01373294
Recruitment Status : Completed
First Posted : June 14, 2011
Results First Posted : May 12, 2016
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bladder Cancer
Interventions Drug: Bacille Calmette-Guerrin (BCG)
Drug: Lenalidomide
Enrollment 17
Recruitment Details Moffitt Cancer Center recruited participants between November 2011 and September 2014.
Pre-assignment Details Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer.
Arm/Group Title A: Combination Arm B: Control Arm
Hide Arm/Group Description Bacille Calmette-Guerrin (BCG) and lenalidomide. Bacille Calmette-Guerrin (BCG).
Period Title: Overall Study
Started 15 2
Completed 14 2
Not Completed 1 0
Reason Not Completed
Adverse Event             1             0
Arm/Group Title A: Combination Arm B: Control Arm Total
Hide Arm/Group Description Bacille Calmette-Guerrin (BCG) and lenalidomide. Bacille Calmette-Guerrin (BCG). Total of all reporting groups
Overall Number of Baseline Participants 15 2 17
Hide Baseline Analysis Population Description
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.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 2 participants 17 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  20.0%
0
   0.0%
3
  17.6%
>=65 years
12
  80.0%
2
 100.0%
14
  82.4%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants 2 participants 17 participants
72
(52 to 85)
70
(66 to 74)
71.8
(52 to 85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 2 participants 17 participants
Female
1
   6.7%
0
   0.0%
1
   5.9%
Male
14
  93.3%
2
 100.0%
16
  94.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 2 participants 17 participants
15 2 17
1.Primary Outcome
Title Arm A: Progression Free Survival (PFS)
Hide Description The 1-year progression free/ recurrence free/ bladder-intact survival was tabulated for the experimental arm for a median follow-up period of 369 days. The progression free/ recurrence free/ bladder-intact survival is defined as the time from start of study treatment to first documentation of objective tumor progression, recurrence, bladder resection or irradiation or to death due to any cause, whichever comes first. PFS data was not collected for participants in the Arm B: Control because too few participants were enrolled in Arm B to conduct the planned per Arm comparison
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Experimental Arm A Group Only.
Arm/Group Title A: Combination Arm
Hide Arm/Group Description:
Bacille Calmette-Guerrin (BCG) and lenalidomide.
Overall Number of Participants Analyzed 15
Measure Type: Number
Unit of Measure: participants
8
2.Secondary Outcome
Title Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hide Description Number of participants with treatment emergent AEs or SAEs per category. SAEs will be specifically labeled as such. Participants were assessed at monthly intervals (corresponding to Revlimid™ refill points for adverse events), classified by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and these were tabulated.
Time Frame Duration of study treatment and follow-up - average of 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants.
Arm/Group Title A: Combination Arm B: Control Arm
Hide Arm/Group Description:
Bacille Calmette-Guerrin (BCG) and lenalidomide.
Bacille Calmette-Guerrin (BCG).
Overall Number of Participants Analyzed 15 2
Measure Type: Number
Unit of Measure: participants
Hematuria 6 1
Urinary frequency 3 0
Urinary urgency 3 1
Urinary tract pain 2 0
Bladder spasm 1 0
Fatigue 7 0
Edema face 1 0
Edema limbs 1 0
Fever 1 0
Pain 1 0
Nausea 2 0
Erythroderma 1 0
Pruritus 1 0
Rash acneiform 1 0
Rash maculo-papular 1 0
Urinary tract infection 2 0
Pharyngitis 1 0
Platelet count decreased 1 0
SAE: Grade 3 Myocardial infarction 1 0
Headache 1 0
Peripheral sensory neuropathy 1 0
3.Other Pre-specified Outcome
Title Effect of Addition of Revlimid on Cytokines
Hide Description The immunologic impact of the addition of Revlimid™ to BCG for secondary prevention of non-muscle-invasive transitional cell bladder cancer, in terms of a panel of correlative assays. The effect of addition of Revlimid on cytokines associated with generation of immune response and on cytotoxic T lymphocytes and memory phenotype lymphocytes.
Time Frame Duration of study treatment and follow-up - average of 12 months
Outcome Measure Data Not Reported
4.Other Pre-specified Outcome
Title Comparison of the Correlative Assay
Hide Description For comparing the correlative assay results of ever-relapsers vs non-relapsers, the combined data with the monotherapy and combination therapy groups would be applied. The participants would be categorized based on 1-year relapse.
Time Frame 1 year post disease response
Outcome Measure Data Not Reported
Time Frame 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A: Combination Arm B: Control Arm
Hide Arm/Group Description Bacille Calmette-Guerrin (BCG) and lenalidomide. Bacille Calmette-Guerrin (BCG).
All-Cause Mortality
A: Combination Arm B: Control Arm
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
A: Combination Arm B: Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/15 (13.33%)      0/2 (0.00%)    
Cardiac disorders     
Myocardial infarction  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Nervous system disorders     
Dizziness  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Vascular disorders     
Hypertension  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A: Combination Arm B: Control Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/15 (100.00%)      1/2 (50.00%)    
Blood and lymphatic system disorders     
Blood and lymphatic system disorders - Other, blood clots in urine  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Cardiac disorders     
Atrial flutter  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  3/15 (20.00%)  5 0/2 (0.00%)  0
Diarrhea  1  3/15 (20.00%)  3 0/2 (0.00%)  0
Nausea  1  2/15 (13.33%)  2 0/2 (0.00%)  0
Gastrointestinal disorders - Other, soreness over suprapubic area  1  1/15 (6.67%)  1 0/2 (0.00%)  0
General disorders     
Fatigue  1  7/15 (46.67%)  9 0/2 (0.00%)  0
Edema face  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Edema limbs  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Fever  1  1/15 (6.67%)  2 0/2 (0.00%)  0
Pain  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Infections and infestations     
Urinary tract infection  1  3/15 (20.00%)  4 0/2 (0.00%)  0
Pharyngitis  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Investigations     
Weight loss  1  2/15 (13.33%)  2 0/2 (0.00%)  0
Platelet count decreased  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Generalized muscle weakness  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Nervous system disorders     
Headache  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Peripheral sensory neuropathy  1  1/15 (6.67%)  2 0/2 (0.00%)  0
Psychiatric disorders     
Anxiety  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Depression  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Renal and urinary disorders     
Hematuria  1  7/15 (46.67%)  9 0/2 (0.00%)  0
Urinary frequency  1  3/15 (20.00%)  5 0/2 (0.00%)  0
Urinary urgency  1  3/15 (20.00%)  3 0/2 (0.00%)  0
Urinary tract pain  1  2/15 (13.33%)  3 0/2 (0.00%)  0
Bladder spasm  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Urinary incontinence  1  0/15 (0.00%)  0 1/2 (50.00%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Dyspnea  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Epistaxis  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Skin and subcutaneous tissue disorders     
Erythroderma  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Pruritus  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Rash acneiform  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Rash maculo-papular  1  1/15 (6.67%)  1 0/2 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
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.
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
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. )
First Submitted: June 13, 2011
First Posted: June 14, 2011
Results First Submitted: December 28, 2015
Results First Posted: May 12, 2016
Last Update Posted: March 15, 2019