Trial Outcomes & Findings for Oral Lenalidomide and Intravesical BCG for Therapy of Bladder Cancer (NCT NCT01373294)
NCT ID: NCT01373294
Last Updated: 2019-08-06
Results Overview
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
COMPLETED
PHASE2
17 participants
1 year
2019-08-06
Participant Flow
Moffitt Cancer Center recruited participants between November 2011 and September 2014.
Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer.
Participant milestones
| Measure |
A: Combination Arm
Bacille Calmette-Guerrin (BCG) and lenalidomide.
|
B: Control Arm
Bacille Calmette-Guerrin (BCG).
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
2
|
|
Overall Study
COMPLETED
|
14
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
A: Combination Arm
Bacille Calmette-Guerrin (BCG) and lenalidomide.
|
B: Control Arm
Bacille Calmette-Guerrin (BCG).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
Baseline Characteristics
Oral Lenalidomide and Intravesical BCG for Therapy of Bladder Cancer
Baseline characteristics by cohort
| Measure |
A: Combination Arm
n=15 Participants
Bacille Calmette-Guerrin (BCG) and lenalidomide.
|
B: Control Arm
n=2 Participants
Bacille Calmette-Guerrin (BCG).
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Continuous
|
72 years
n=5 Participants
|
70 years
n=7 Participants
|
71.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
2 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Experimental Arm A Group Only.
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
Outcome measures
| Measure |
A: Combination Arm
n=15 Participants
Bacille Calmette-Guerrin (BCG) and lenalidomide.
|
B: Control Arm
Bacille Calmette-Guerrin (BCG).
|
|---|---|---|
|
Arm A: Progression Free Survival (PFS)
|
8 participants
|
—
|
SECONDARY outcome
Timeframe: Duration of study treatment and follow-up - average of 12 monthsPopulation: All participants.
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.
Outcome measures
| Measure |
A: Combination Arm
n=15 Participants
Bacille Calmette-Guerrin (BCG) and lenalidomide.
|
B: Control Arm
n=2 Participants
Bacille Calmette-Guerrin (BCG).
|
|---|---|---|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Urinary frequency
|
3 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Urinary tract pain
|
2 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Bladder spasm
|
1 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Pharyngitis
|
1 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Hematuria
|
6 participants
|
1 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Urinary urgency
|
3 participants
|
1 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Fatigue
|
7 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Edema face
|
1 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Edema limbs
|
1 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Fever
|
1 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Pain
|
1 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Nausea
|
2 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Erythroderma
|
1 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Pruritus
|
1 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Rash acneiform
|
1 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Rash maculo-papular
|
1 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Urinary tract infection
|
2 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Platelet count decreased
|
1 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
SAE: Grade 3 Myocardial infarction
|
1 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Headache
|
1 participants
|
0 participants
|
|
Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Peripheral sensory neuropathy
|
1 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of study treatment and follow-up - average of 12 monthsThe 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.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 year post disease responseFor 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.
Outcome measures
Outcome data not reported
Adverse Events
A: Combination Arm
B: Control Arm
Serious adverse events
| Measure |
A: Combination Arm
n=15 participants at risk
Bacille Calmette-Guerrin (BCG) and lenalidomide.
|
B: Control Arm
n=2 participants at risk
Bacille Calmette-Guerrin (BCG).
|
|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Vascular disorders
Hypertension
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Nervous system disorders
Dizziness
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
Other adverse events
| Measure |
A: Combination Arm
n=15 participants at risk
Bacille Calmette-Guerrin (BCG) and lenalidomide.
|
B: Control Arm
n=2 participants at risk
Bacille Calmette-Guerrin (BCG).
|
|---|---|---|
|
Renal and urinary disorders
Hematuria
|
46.7%
7/15 • Number of events 9 • 36 months
|
0.00%
0/2 • 36 months
|
|
Renal and urinary disorders
Urinary frequency
|
20.0%
3/15 • Number of events 5 • 36 months
|
0.00%
0/2 • 36 months
|
|
Renal and urinary disorders
Urinary urgency
|
20.0%
3/15 • Number of events 3 • 36 months
|
0.00%
0/2 • 36 months
|
|
Renal and urinary disorders
Urinary tract pain
|
13.3%
2/15 • Number of events 3 • 36 months
|
0.00%
0/2 • 36 months
|
|
Renal and urinary disorders
Bladder spasm
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/15 • 36 months
|
50.0%
1/2 • Number of events 1 • 36 months
|
|
General disorders
Fatigue
|
46.7%
7/15 • Number of events 9 • 36 months
|
0.00%
0/2 • 36 months
|
|
General disorders
Edema face
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
General disorders
Edema limbs
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 2 • 36 months
|
0.00%
0/2 • 36 months
|
|
General disorders
Pain
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
3/15 • Number of events 5 • 36 months
|
0.00%
0/2 • 36 months
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
3/15 • Number of events 3 • 36 months
|
0.00%
0/2 • 36 months
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 2 • 36 months
|
0.00%
0/2 • 36 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, soreness over suprapubic area
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Infections and infestations
Urinary tract infection
|
20.0%
3/15 • Number of events 4 • 36 months
|
0.00%
0/2 • 36 months
|
|
Infections and infestations
Pharyngitis
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Skin and subcutaneous tissue disorders
Erythroderma
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Investigations
Weight loss
|
13.3%
2/15 • Number of events 2 • 36 months
|
0.00%
0/2 • 36 months
|
|
Investigations
Platelet count decreased
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Cardiac disorders
Atrial flutter
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.7%
1/15 • Number of events 2 • 36 months
|
0.00%
0/2 • 36 months
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Psychiatric disorders
Depression
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, blood clots in urine
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
6.7%
1/15 • Number of events 1 • 36 months
|
0.00%
0/2 • 36 months
|
Additional Information
Dr. Mayer Fishman
H. Lee Moffitt Cancer Center and Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place