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The purpose of this study is to determine the safety of and to select a treatment regimen of pomalidomide (CC-4047) either as single-agent or in combination with prednisone to study further in patients with myelofibrosis with myeloid metaplasia (MMM).
Participants received study treatment in the Double Blind Treatment Phase for up to 12 cycles (336 days; 12 cycles of 28 days each). Participants who completed the Double-Blind Treatment Phase were unblinded and, if receiving pomalidomide and determined to have a complete remission (CR), partial remission (PR) or clinical improvement (CI) using the International Working Group (IWG) Response Criteria in the study protocol, could have continued on their current dose of pomalidomide until disease progression. Participants receiving placebo were discontinued from the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisone | Experimental | Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, participants were discontinued from the study. |
|
| Pomalidomide | Experimental | Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase. After the completion of Cycle 12 and upon unblinding, participants determined to have a complete remission (CR), partial remission (PR) or clinical improvement (CI) using the International Working Group (IWG) Response Criteria in the study protocol, were eligible to participate in the extension phase and continue to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle, until disease progression, unacceptable toxicity or voluntary withdrawal. |
|
| Pomalidomide 2 mg + Prednisone | Experimental | Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, participants determined to have a complete remission (CR), partial remission (PR) or clinical improvement (CI) using the International Working Group (IWG) Response Criteria in the study protocol, were eligible to participate in the extension phase and continue to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle, until disease progression, unacceptable toxicity or voluntary withdrawal. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomalidomide | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Clinical Response Within the First 6 Cycles of Treatment | A clinical responder was defined as either:
Participants who discontinued the study early without achieving clinical response were counted as non-responders. | Up to 168 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Clinical Response Within the First 12 Cycles of Treatment | A clinical responder was defined as either:
Participants who discontinued the study early without achieving clinical response were counted as non-responders. |
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Inclusion Criteria:
Must sign an informed consent form
Must be >18 years of age
Must be diagnosed with myelofibrosis
Eligibility is based on local pathology review of bone marrow aspirate and biopsy
Screening total hemoglobin level < 10g/dL or transfusion-dependent anemia defined as per International Working Group (IWG) criteria.
Must have adequate organ function as demonstrated by the following ≤ 14 days prior to starting study drug:
Patients must be willing to receive transfusion of blood products
Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at screening.
Must be able to adhere to the study visit schedule and other protocol requirements.
No active malignancies with the exception of controlled prostate cancer, basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix or breast.
Must agree to follow pregnancy precautions as required per the protocol
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Peter Gale, MD, PhD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA School of Medicine Hematology/Oncology | Los Angeles | California | 90095 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Barosi G, et al. Decrease Of T Regulatory Cells In Patients With Myelofibrosis Receiving Ruxolitinib. Presented at American Society of Hematology 2013, December 7-10, 2013, New Orleans, LA. Abstract No. 4057. Blood, 2013;122(21) |
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| ID | Title | Description |
|---|---|---|
| FG000 | Prednisone | Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, participants were discontinued from the study. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Pomalidomide 0.5 mg + Prednisone | Experimental | Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, participants determined to have a complete remission (CR), partial remission (PR) or clinical improvement (CI) using the International Working Group (IWG) Response Criteria in the study protocol, were eligible to participate in the extension phase and continue to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle, until disease progression, unacceptable toxicity or voluntary withdrawal. |
|
| Prednisone | Drug | Participants will take oral prednisone in the evening for 3 cycles of 28 days each (up to 84 days). The dose will be as follows: 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day. |
|
| Placebo to pomalidomide | Drug | Matching pomalidomide placebo tablets |
|
| Placebo to prednisone | Drug | Matching prednisone placebo tablets |
|
| Up to 336 days |
| Time to the First Clinical Response | The time to the first clinical response achieved within 168 days after the first study drug dosing date was calculated for participants who achieved a clinical response as: Start date of the first clinical response - the first study drug date +1. A clinical responder was defined as either:
| Up to 168 days |
| Duration of First Clinical Response | For RBC-transfusion-dependent patients, duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the date of the first RBC-transfusion administrated at or more than 56 days after the response started. For patients who did not receive a subsequent transfusion after the response started, the end date of response was censored at the day of last hemoglobin assessment. For RBC-transfusion-independent patients, the duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the earlier of the date of a hemoglobin increase of < 2.0 g/dL and the date of a RBC transfusion at ≥ 56 days after the response started. For patients whose hemoglobin measurements were always ≥ 2.0 g/dL and never received a RBC transfusion after response started, the end date of the response was censored at the date of last hemoglobin measurement. Kaplan-Meier methodology was used. | Up to 40 months |
| Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale and Total Scores | The FACT-An comprises the four subscales of the 27-item FACT-General Scale (FACT-G), Physical Well-being, Social/Family Well-being, Emotion Well-being, Functional Well-Being, and the Additional Concerns Anemia subscale. Questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life.
| Baseline and Cycle 6 (168 days). |
| Change From Baseline in Hemoglobin Concentration for Responders | Change from Baseline in hemoglobin for participants with a clinical response within the first 6 cycles of treatment. | Baseline, Cycle 6 (168 days) |
| Change From Baseline in Hemoglobin Concentration for Non-Responders | Change from Baseline in hemoglobin for participants without a clinical response within the first 6 cycles of treatment. | Baseline, Cycle 6 (168 days) |
| Change From Baseline in Likert Abdominal Pain Scale | Participants rated abdominal discomfort or pain over the previous week on a scale from zero to ten, where zero is no discomfort or pain and ten is the worst pain imaginable. | Baseline and Cycle 6 (168 days) |
| Percentage of Participants With Clinical Response by Baseline JAK2 Assessment | Percentage of participants who achieved a clinical response, presented by participants with positive and negative janus kinase 2 (JAK2) V617F mutation results at Baseline. | Up to 336 days |
| Number of Participants With Adverse Events (AEs) | A serious AE (SAE) was defined as any AE which resulted in death or was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or constituted an important medical event (events that may have jeopardized the patient or required intervention to prevent one of the outcomes listed above). The severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) or according to the following scale: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Death. The Investigator determined the relationship between study drug and the occurrence of an AE as "Not Related" or "Related" (since the study was double-blinded, a patient receiving only prednisone could have an AE that was judged as related to pomalidomide, and vice-versa). | From date of the first dose of the study drug until discontinuation or the data cut-off date (up to approximately 45 months). |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021-6007 | United States |
| New York Presbyterian HospitalWeill Medical College of Cornell University | New York | New York | 10021 | United States |
| MD Anderson Cancer Center Leukemia Department | Houston | Texas | 77030 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-4417 | United States |
| Medical University of Vienna, Department of Internal Medicine, Hematology | Vienna | A-1090 | Austria |
| Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
| IRCCS Policlinico S. Matteo | Pavia | 27100 | Italy |
| Hematology DepartmentHospital Clinic | Barcelona | 08036 | Spain |
| Royal Hallamshire Hospital Sheffield Teaching Hospitals NHS Trust | Sheffield | S10 2JF | United Kingdom |
| FG001 | Pomalidomide 2 mg | Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| FG002 | Pomalidomide 2 mg + Prednisone | Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| FG003 | Pomalidomide 0.5 mg + Prednisone | Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Prednisone | Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, participants were discontinued from the study. |
| BG001 | Pomalidomide 2 mg | Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| BG002 | Pomalidomide 2 mg + Prednisone | Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| BG003 | Pomalidomide 0.5 mg + Prednisone | Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Janus kinase 2 (JAK2) Mutation | JAK2^V617F mutation result based on quantitative polymerase chain reaction (PCR) analysis in neutrophil preparation. | Number | participants |
| |||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG performance status scale and criteria used to assess disease progression, how the disease affects the daily living abilities of the patient, and determine appropriate treatment: 0=Fully active, able to carry on all pre-disease activities;
| Number | participants |
| |||||||||||||||
| Myelofibrosis with myeloid metaplasia Subtype | Number | participants |
| ||||||||||||||||
| Time Since Myelofibrosis Diagnosis | Median | Full Range | years |
| |||||||||||||||
| Red Blood Cell (RBC) Transfusion Dependence | A patient who receives at least a total of two units of RBC transfusion within 28 days on or prior to the first study drug dosing date is an RBC-transfusion-dependent patient. Otherwise a patient is an RBC-transfusion-independent patient. | Number | participants |
| |||||||||||||||
| RBC Transfusion Burden | Median | Full Range | units/28 days |
|
| 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 | Percentage of Participants With a Clinical Response Within the First 6 Cycles of Treatment | A clinical responder was defined as either:
Participants who discontinued the study early without achieving clinical response were counted as non-responders. | Modified intent-to-treat (MITT), defined as the patients who had a confirmed diagnosis of Myelofibrosis with myeloid metaplasia (MMM), received at least one dose of study drug, and participated in the study for at least 56 days. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 168 days |
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| Secondary | Percentage of Participants With a Clinical Response Within the First 12 Cycles of Treatment | A clinical responder was defined as either:
Participants who discontinued the study early without achieving clinical response were counted as non-responders. | Intent-to-treat (ITT), defined as as all patients who were randomized, independent of whether they received study treatment or not. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 336 days |
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| Secondary | Time to the First Clinical Response | The time to the first clinical response achieved within 168 days after the first study drug dosing date was calculated for participants who achieved a clinical response as: Start date of the first clinical response - the first study drug date +1. A clinical responder was defined as either:
| Intent-to-treat population with a clinical response | Posted | Median | Full Range | weeks | Up to 168 days |
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| Secondary | Duration of First Clinical Response | For RBC-transfusion-dependent patients, duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the date of the first RBC-transfusion administrated at or more than 56 days after the response started. For patients who did not receive a subsequent transfusion after the response started, the end date of response was censored at the day of last hemoglobin assessment. For RBC-transfusion-independent patients, the duration of response was calculated as the last day of response - first day of response +1, where the last day of response was the earlier of the date of a hemoglobin increase of < 2.0 g/dL and the date of a RBC transfusion at ≥ 56 days after the response started. For patients whose hemoglobin measurements were always ≥ 2.0 g/dL and never received a RBC transfusion after response started, the end date of the response was censored at the date of last hemoglobin measurement. Kaplan-Meier methodology was used. | Intent-to-treat population with a clinical response. | Posted | Median | 95% Confidence Interval | months | Up to 40 months |
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| Secondary | Change From Baseline in Functional Assessment of Cancer Therapy-Anemia (FACT-An) Subscale and Total Scores | The FACT-An comprises the four subscales of the 27-item FACT-General Scale (FACT-G), Physical Well-being, Social/Family Well-being, Emotion Well-being, Functional Well-Being, and the Additional Concerns Anemia subscale. Questions are rated on a scale from 0 to 4, where higher scores indicate more impact on quality of life.
| Intent-to-treat patients with available data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Cycle 6 (168 days). |
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| Secondary | Change From Baseline in Hemoglobin Concentration for Responders | Change from Baseline in hemoglobin for participants with a clinical response within the first 6 cycles of treatment. | Intent-to-treat participants with a clinical response and available hemoglobin values at each time point. | Posted | Median | Full Range | g/dL | Baseline, Cycle 6 (168 days) |
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| Secondary | Change From Baseline in Hemoglobin Concentration for Non-Responders | Change from Baseline in hemoglobin for participants without a clinical response within the first 6 cycles of treatment. | Intent-to-treat participants with no clinical response and available hemoglobin values at each time point. | Posted | Median | Full Range | g/dL | Baseline, Cycle 6 (168 days) |
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| Secondary | Change From Baseline in Likert Abdominal Pain Scale | Participants rated abdominal discomfort or pain over the previous week on a scale from zero to ten, where zero is no discomfort or pain and ten is the worst pain imaginable. | Intent-to-treat patients with available data. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Cycle 6 (168 days) |
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| Secondary | Percentage of Participants With Clinical Response by Baseline JAK2 Assessment | Percentage of participants who achieved a clinical response, presented by participants with positive and negative janus kinase 2 (JAK2) V617F mutation results at Baseline. | Intent-to-treat population with non-missing JAK2 Baseline assessment results. The number of participants analyzed indicates the number of participants with a positive or negative JAK2 result for each treatment group respectively. | Posted | Number | percentage of participants | Up to 336 days |
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| Secondary | Number of Participants With Adverse Events (AEs) | A serious AE (SAE) was defined as any AE which resulted in death or was life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or constituted an important medical event (events that may have jeopardized the patient or required intervention to prevent one of the outcomes listed above). The severity of AEs were graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) or according to the following scale: Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Life-threatening; Grade 5 = Death. The Investigator determined the relationship between study drug and the occurrence of an AE as "Not Related" or "Related" (since the study was double-blinded, a patient receiving only prednisone could have an AE that was judged as related to pomalidomide, and vice-versa). | Safety population (all treated patients). | Posted | Number | participants | From date of the first dose of the study drug until discontinuation or the data cut-off date (up to approximately 45 months). |
|
From the first dose of the study drug through to 30 days after the last dose; up to the data cut-off date of 18 December 2013; up to 81 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 | Prednisone | Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, participants were discontinued from the study. | 6 | 22 | 20 | 22 | ||
| EG001 | Pomalidomide 2 mg | Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. | 10 | 22 | 20 | 22 | ||
| EG002 | Pomalidomide 2 mg + Prednisone | Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. | 11 | 19 | 17 | 19 | ||
| EG003 | Pomalidomide 0.5 mg + Prednisone | Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. | 9 | 22 | 21 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial Flutter | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cardiac Failure | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Atrial Fibrillation | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cardiac Failure Acute | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Left Ventricular Dysfunction | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Right Ventricular Failure | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Septic Shock | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Lobar Pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Lung Infection Pseudomonal | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Perirectal Abscess | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Urinary Tract Infection Enterococcal | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cachexia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Failure To Thrive | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Fluid Retention | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Lower Gastrointestinal Haemorrhage | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Varices Oesophageal | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cerebral Haemorrhage | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cognitive Disorder | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hepatic Encephalopathy | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Eosinophilia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Febrile Neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haemolytic Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Leukocytosis | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Disease Progression | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Thoracic Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Traumatic Brain Injury | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| International Normalised Ratio Increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Renal Failure Acute | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Renal Failure Chronic | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Lung Infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Deep Vein Thrombosis | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Acquired Von Willebrand Disease | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Chills | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Feeling Jittery | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pleuritic Pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oral Pain | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Abdominal Distension | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Gingival Bleeding | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Tongue Ulceration | Gastrointestinal disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Burning Sensation | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Memory Impairment | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Aphonia | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Balance Disorder | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dementia Alzheimer's Type | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Bone Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Muscular Weakness | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Musculoskeletal Chest Pain | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Enterococcal Sepsis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Eye Infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Respiratory Tract Infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (9.0) | Systematic Assessment |
| |
| Increased Tendency To Bruise | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Night Sweats | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Rash Pruritic | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Skin Odour Abnormal | Skin and subcutaneous tissue disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Mental Status Changes | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Personality Change | Psychiatric disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Eye Irritation | Eye disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Lacrimation Increased | Eye disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Periorbital Oedema | Eye disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Heart Rate Increased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Cardiac Murmur | Investigations | MedDRA (9.0) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Arrhythmia | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Sinus Bradycardia | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Ear Congestion | Ear and labyrinth disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Seasonal Allergy | Immune system disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA (9.0) | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Urinary Incontinence | Renal and urinary disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Benign Prostatic Hyperplasia | Reproductive system and breast disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (9.0) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (9.0) | Systematic Assessment |
|
The investigator shall have the right to publish and/or present study data provided that the investigator shall (i) furnish the sponsor a copy of any proposed publication or presentation generally thirty (60) days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials Disclosure | Celgene Corporation | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| D007947 | Leukemia, Megakaryoblastic, Acute |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D015470 | Leukemia, Myeloid, Acute |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C467566 | pomalidomide |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| Black |
|
| Hispanic |
|
| Positive |
|
| Missing |
|
| Grade 1 |
|
| Grade 2 |
|
| Missing |
|
| Postpolycythemic Myeloid Metaplasia (PPMM) |
|
| Postthromocythemic Myeloid Metaplasia (PTMM) |
|
| No |
|
| 95 |
| Superiority or Other (legacy) |
| Fisher Exact | 0.758 | 95 | Superiority or Other (legacy) |
Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.
| OG002 | Pomalidomide 2 mg + Prednisone | Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG003 | Pomalidomide 0.5 mg + Prednisone | Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
|
|
| OG002 | Pomalidomide 2 mg + Prednisone | Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG003 | Pomalidomide 0.5 mg + Prednisone | Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
|
|
| Pomalidomide 2 mg |
Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG002 | Pomalidomide 2 mg + Prednisone | Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG003 | Pomalidomide 0.5 mg + Prednisone | Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
|
|
Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.
After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal.
| OG002 | Pomalidomide 2 mg + Prednisone | Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG003 | Pomalidomide 0.5 mg + Prednisone | Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
|
|
| Pomalidomide 2 mg + Prednisone |
Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG003 | Pomalidomide 0.5 mg + Prednisone | Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
|
|
| Pomalidomide 2 mg + Prednisone |
Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG003 | Pomalidomide 0.5 mg + Prednisone | Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
|
|
| Pomalidomide 2 mg + Prednisone |
Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG003 | Pomalidomide 0.5 mg + Prednisone | Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
|
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| OG002 | Pomalidomide 2 mg + Prednisone, Positive JAK2 | Participants with a positive JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG003 | Pomalidomide 0.5 mg + Prednisone, Positive JAK2 | Participants with a positive JAK2 result at Baseline received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG004 | Prednisone, Negative JAK2 | Participants with a negative JAK2 result at Baseline received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, participants were discontinued from the study. |
| OG005 | Pomalidomide 2 mg, Negative JAK2 | Participants with a negative JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG006 | Pomalidomide 2 mg + Prednisone, Negative JAK2 | Participants with a negative JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG007 | Pomalidomide 0.5 mg + Prednisone, Negative JAK2 | Participants with a negative JAK2 result at Baseline received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
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| OG001 |
| Pomalidomide 2 mg |
Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG002 | Pomalidomide 2 mg + Prednisone | Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
| OG003 | Pomalidomide 0.5 mg + Prednisone | Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase. After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal. |
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