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| ID | Type | Description | Link |
|---|---|---|---|
| RV-BLD-PI-0330 | Other Identifier | Celgene Corp. |
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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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The purposes of this study are to:
Investigators planned to screen approximately 100 people with bladder cancer who are 18 years of age or older throughout the United States for this study.
This is a multi-center study combining two marketed drugs, one of which has not been used previously in people with transitional cell cancer. Lenalidomide (Revlimid®) is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the U.S. Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. Lenalidomide is currently being tested in a variety of cancer conditions. It is not approved by the FDA for use in people with bladder cancer, so in this case it is considered experimental.
The other drug used in this study is Bacille Calmette-Guerrin (BCG). BCG is approved by the FDA for use in people with bladder cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Combination Arm | Experimental | Bacille Calmette-Guerrin (BCG) and lenalidomide. Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer. This group received BCG + lenalidomide) |
|
| B: Control Arm | Active Comparator | Bacille Calmette-Guerrin (BCG) only. Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer. This group was not eligible to receive the combination of BCG + lenalidomide. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacille Calmette-Guerrin (BCG) | Drug | Participants will receive BCG instillations once per week for the first 6 weeks. At 3 months and 6 months, participants will receive BCG instillations once per week for three weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Arm A: Progression Free Survival (PFS) | 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | 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 Revlimidâ„¢ refill points for adverse events), classified by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and these were tabulated. |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Addition of Revlimid on Cytokines | The immunologic impact of the addition of Revlimidâ„¢ 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. | Duration of study treatment and follow-up - average of 12 months |
Inclusion Criteria - Either control group or combination treatment:
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| Name | Affiliation | Role |
|---|---|---|
| Mayer Fishman, M.D., Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
Participants were assigned to receive BCG or BCG and lenalidomide based on their cancer.
Moffitt Cancer Center recruited participants between November 2011 and September 2014.
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| ID | Title | Description |
|---|---|---|
| FG000 | A: Combination Arm | Bacille Calmette-Guerrin (BCG) and lenalidomide. |
| FG001 | B: Control Arm | Bacille Calmette-Guerrin (BCG). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | A: Combination Arm | Bacille Calmette-Guerrin (BCG) and lenalidomide. |
| BG001 | B: Control Arm | Bacille Calmette-Guerrin (BCG). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Arm A: Progression Free Survival (PFS) | 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 | Experimental Arm A Group Only. | Posted | Number | participants | 1 year |
|
36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A: Combination Arm | Bacille Calmette-Guerrin (BCG) and lenalidomide. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hematuria | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mayer Fishman | H. Lee Moffitt Cancer Center and Research Institute | 813-745-8311 | mayer.fishman@moffitt.org |
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| ID | Term |
|---|---|
| D001749 | Urinary Bladder Neoplasms |
| ID | Term |
|---|---|
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001500 | BCG Vaccine |
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| D032581 | Tuberculosis Vaccines |
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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|
| Lenalidomide | Drug | Participants may also receive capsules of lenalidomide 10 mg to swallow once per day for 7 months. The study doctor will tell participants if they will be taking lenalidomide. |
|
|
| Duration of study treatment and follow-up - average of 12 months |
| Comparison of the Correlative Assay | 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. | 1 year post disease response |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Treatment Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | 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 Revlimidâ„¢ refill points for adverse events), classified by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, and these were tabulated. | All participants. | Posted | Number | participants | Duration of study treatment and follow-up - average of 12 months |
|
|
|
| Other Pre-specified | Effect of Addition of Revlimid on Cytokines | The immunologic impact of the addition of Revlimidâ„¢ 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. | Not Posted | Duration of study treatment and follow-up - average of 12 months | Participants |
| Other Pre-specified | Comparison of the Correlative Assay | 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. | Not Posted | 1 year post disease response | Participants |
| 2 |
| 15 |
| 15 |
| 15 |
| EG001 | B: Control Arm | Bacille Calmette-Guerrin (BCG). | 0 | 2 | 1 | 2 |
| Hypertension | Vascular disorders | CTCAE v4.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Urinary urgency | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
|
| Bladder spasm | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | CTCAE v4.0 | Systematic Assessment |
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| Fatigue | General disorders | CTCAE v4.0 | Systematic Assessment |
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| Edema face | General disorders | CTCAE v4.0 | Systematic Assessment |
|
| Edema limbs | General disorders | CTCAE v4.0 | Systematic Assessment |
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| Fever | General disorders | CTCAE v4.0 | Systematic Assessment |
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| Pain | General disorders | CTCAE v4.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Gastrointestinal disorders - Other, soreness over suprapubic area | Gastrointestinal disorders | CTCAE v4.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | CTCAE v4.0 | Systematic Assessment |
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| Erythroderma | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Rash acneiform | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
| Weight loss | Investigations | CTCAE v4.0 | Systematic Assessment |
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| Platelet count decreased | Investigations | CTCAE v4.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE v4.0 | Systematic Assessment |
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| Atrial flutter | Cardiac disorders | CTCAE v4.0 | Systematic Assessment |
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| Headache | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | CTCAE v4.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | CTCAE v4.0 | Systematic Assessment |
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| Blood and lymphatic system disorders - Other, blood clots in urine | Blood and lymphatic system disorders | CTCAE v4.0 | Systematic Assessment |
|
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE v4.0 | Systematic Assessment |
|
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D045424 |
| Complex Mixtures |
| D010797 | Phthalimides |
| D010795 | Phthalic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010881 | Piperidones |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D054833 | Isoindoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| Urinary urgency |
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| Urinary tract pain |
|
| Bladder spasm |
|
| Fatigue |
|
| Edema face |
|
| Edema limbs |
|
| Fever |
|
| Pain |
|
| Nausea |
|
| Erythroderma |
|
| Pruritus |
|
| Rash acneiform |
|
| Rash maculo-papular |
|
| Urinary tract infection |
|
| Pharyngitis |
|
| Platelet count decreased |
|
| SAE: Grade 3 Myocardial infarction |
|
| Headache |
|
| Peripheral sensory neuropathy |
|