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This study is a multicenter, single-arm, open-label study of oral lenalidomide monotherapy administered to red blood cell (RBC) transfusion-dependent subjects with low- or intermediate-1-risk Myelodysplastic Syndromes (MDS) associated with a del (5q31-33) cytogenetic abnormality. Screening procedures will take place within 28 days of the first day of lenalidomide treatment. Subjects will receive lenalidomide in 28-day cycles for up to 6 cycles, or until bone marrow disease progression or progression/relapse following erythroid hematologic improvement is documented. Study visits will occur every cycle (every 28 days) and laboratory monitoring to assess hematological parameters will occur every 14 days. Safety and efficacy assessments to be performed during the study are outlined in the Schedule of Study Assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lenalidomide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lenalidomide | Drug | 10 mg orally once daily for 21 days out of a 28-day cycle (syncopated); subsequently amended (Amendment 1, dated 27 August 2003) to employ a continuous dosage regimen in which 10 mg was taken once daily for 28 day cycles (continuous). Subjects who initially began a syncopated regimen and who did not experience a dose-limiting adverse event were allowed to switch to the continuous regimen. |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence | Number of participants who achieved RBC-transfusion independence, which was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive "rolling" 56 days during the treatment period (eg, Days 1 to 56, Days 2 to 57, Days 3 to 58, etc), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Participants With Adverse Experiences | Counts of study participants who had adverse events (AEs) during the study. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator. The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan F List, MD | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Cancer Center | Scottsdale | Arizona | 85258 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19018091 | Background | Sekeres MA, Maciejewski JP, Giagounidis AA, Wride K, Knight R, Raza A, List AF. Relationship of treatment-related cytopenias and response to lenalidomide in patients with lower-risk myelodysplastic syndromes. J Clin Oncol. 2008 Dec 20;26(36):5943-9. doi: 10.1200/JCO.2007.15.5770. Epub 2008 Nov 17. | |
| 29137233 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Lenalidomide | The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| Up to 2 Years |
| Participants With a >= 50% Decrease From Baseline in Red Blood Cell (RBC) Transfusion Requirements Over Any Consecutive 56 Days During Study | A participant was categorized as having a transfusion reduction response if there was a ≥ 50% decrease from pretreatment transfusion requirements (before the start of the study mediation) compared to any consecutive 56 days during the study (i.e. post treatment). | Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years) |
| Time to Transfusion Independence | Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive "rolling" 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Time to transfusion independence was defined as the day of the first dose of study drug to the first day of the first 56-day RBC transfusion-free period. | up to 2 years |
| Participants Who Relapsed or Maintained Their Transfusion Independence After Achieving Transfusion Independence During the Study | Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive "rolling" 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Participants who relapsed required a transfusion after the period of transfusion independence. Participants who maintained transfusion independence did not require a transfusion during the remainder of the study. | up to 2 years |
| Kaplan Meier Estimate for Duration of Transfusion Independence Response | Duration of response is measured from the first of the consecutive 56 days during which the participant was free of RBC transfusions to the date of the first RBC transfusion after this period. Duration of response was censored at the date of last visit for participants who maintained transfusion independence. | up to 2 years |
| Change in Hemoglobin Concentration From Baseline to Maximum Value During Response Period for Responders | The change from baseline in hemoglobin for participants who became RBC-transfusion independent. The maximum hemoglobin value obtained during the response period is used in the calculation of change from baseline. | Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years) |
| Participant Counts of Cytogenetic Response | Participants deemed evaluable by the central cytogenetic review had their cytogenetic response categorized as major or minor. A major cytogenetic response was defined as ≥ 20 metaphases recorded at baseline, and at least 1 post baseline evaluation with ≥ 20 metaphases analyzed with no abnormal metaphases observed. A minor cytogenetic response was defined as ≥ 20 metaphases analyzed at baseline, and at least 1 post baseline evaluation with ≥ 20 metaphases analyzed with a ≥ 50% reduction in the proportion of hematopoietic cells with cytogenetic abnormalities compared with baseline. | up to 2 years |
| Participant Counts of Platelet Response | Major platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3 in all values within 56 days of start of treatment, an absolute increase of ≥30,000/mm^3 sustained for ≥56 consecutive days. In platelet transfusion-dependent participants, a major response was stabilization of platelet counts and platelet transfusion independence. Minor platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3, a ≥ 50% increase in platelet count with a net increase >10,000/mm^3 for a consecutive 56-day period in the absence of platelet transfusions. | up to 2 years |
| Participant Counts of Absolute Neutrophil Count (ANC) Response | Major neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3 in all values obtained within 56 days of start of treatment, a ≥ 100% increase or an absolute increase of ≥ 500/mm^3, whichever was greater (at least to be ≥ 500/mm^3), sustained for 56 consecutive days. Minor neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3, an increase in ANC concentration of ≥ 100% sustained for 56 consecutive days. | up to 2 years |
| Participants With Complete or Partial Bone Marrow Improvement | Bone marrow aspirates were assessed by a central reviewer. A complete bone marrow improvement required a baseline French-American-British (FAB) classification (see Baseline Characteristics) of refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) and a during study assessment of no MDS. A partial bone marrow improvement reflected an improved FAB classification compared to baseline (e.g. RARS to RA) but evidence of MDS continued to exist. | up to 2 years |
| Participants With Bone Marrow Progression | Bone marrow aspirate was assessed by a central reviewer. Progression is represented in two categories according to changes from baseline in French-American-British (FAB) classification (see Baseline Characteristics):
| up to 2 years |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| Arizona Cancer Center | Tucson | Arizona | 85724-5024 | United States |
| Desert Hematology & Oncology Medical Group | Rancho Mirage | California | 92270 | United States |
| Stanford University Medical Center | Stanford | California | 94305-5750 | United States |
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| Cancer & Blood Disease Center | Lecanto | Florida | 34461 | United States |
| University of Miami Sylvester Comp Cancer Center | Miami | Florida | 33136 | United States |
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612-9497 | United States |
| Northwest Georgia Oncology - Wellstar Cancer Research | Marietta | Georgia | 30060 | United States |
| Rush-Presbyterian- St. Luke's Medical Center | Chicago | Illinois | 60612 | United States |
| University of Chicago Medical Center | Chicago | Illinois | 60637-1470 | United States |
| Midwest Cancer Research Group | Skokie | Illinois | 60077 | United States |
| Johns Hopkins Oncology Center | Baltimore | Maryland | 21287-8963 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115-6084 | United States |
| Wayne State University School of Medicine | Detroit | Michigan | 48201-2097 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-7680 | United States |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
| New York Hospital-Cornell | New York | New York | 10021-0034 | United States |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021-6007 | United States |
| Mt. Sinai Medical Center | New York | New York | 10029 | United States |
| University of Rochester- James P. Wilmot Cancer Center | Rochester | New York | 14642 | United States |
| Wake Forest University School of Medicine | Winston-Salem | North Carolina | 27157-1082 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Oregon Health & Science University | Portland | Oregon | 97201 | United States |
| Kaiser Permanente Northwest Region | Portland | Oregon | 97227 | United States |
| Western Pennsylvania Cancer Institute | Pittsburgh | Pennsylvania | 15224 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Swedish Cancer Institute | Seattle | Washington | 98104 | United States |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109-4417 | United States |
| St. Johannes Hospital | Duisburg | Germany |
| Prebet T, Cluzeau T, Park S, Sekeres MA, Germing U, Ades L, Platzbecker U, Gotze K, Vey N, Oliva E, Sugrue MM, Bally C, Kelaidi C, Al Ali N, Fenaux P, Gore SD, Komrokji R. Outcome of patients treated for myelodysplastic syndromes with 5q deletion after failure of lenalidomide therapy. Oncotarget. 2017 Jun 14;8(47):81926-81935. doi: 10.18632/oncotarget.18477. eCollection 2017 Oct 10. |
| 17021321 | Result | List A, Dewald G, Bennett J, Giagounidis A, Raza A, Feldman E, Powell B, Greenberg P, Thomas D, Stone R, Reeder C, Wride K, Patin J, Schmidt M, Zeldis J, Knight R; Myelodysplastic Syndrome-003 Study Investigators. Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion. N Engl J Med. 2006 Oct 5;355(14):1456-65. doi: 10.1056/NEJMoa061292. |
| Result | A.F. List, et.al. Results of the MDS-002 and -003 international phase II studies evaluating lenalidomide (CC-5013; Revlimid) in the treatment of transfusion-dependent (TD) patients with myelodysplastic syndrome (MDS). European Hematology Association 10th Conference June 2-5, 2005 Abstract #0772 |
| 28651604 | Derived | Fenaux P, Giagounidis A, Selleslag D, Beyne-Rauzy O, Mittelman M, Muus P, Nimer SD, Hellstrom-Lindberg E, Powell BL, Guerci-Bresler A, Sekeres MA, Deeg HJ, Del Canizo C, Greenberg PL, Shammo JM, Skikne B, Yu X, List AF. Clinical characteristics and outcomes according to age in lenalidomide-treated patients with RBC transfusion-dependent lower-risk MDS and del(5q). J Hematol Oncol. 2017 Jun 26;10(1):131. doi: 10.1186/s13045-017-0491-2. |
| Modified Intent to Treat Population |
|
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Lenalidomide | The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Age, Customized | Number | participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Duration of Myelodysplastic Syndrome (MDS) | Time from diagnosis of MDS until study start. | Mean | Standard Deviation | years |
| |||||||||||||||||||||
| Participants with 5q(-) (31-33) Chromosomal Abnormality | Number | participants |
| |||||||||||||||||||||||
| International Prognostic Scoring System (IPSS) Score | The international prognostic scoring system (IPSS) is a standard for risk assessment in primary myelodysplastic syndromes (MDS) that categorizes prognoses taking into account cytogenetics, cytopenias, blasts and blood counts. The IPSS prognostic subgroups consist of low-, intermediate-1-, intermediate-2-, and high-risk groups. The scale is 0-3.5 at 0.5 increments. Scores of 0=Low; 0.5-1.0=Int-1; 1.5-2.0=Int-2; 2.5-3.5=High risk which corresponds to poorer prognosis. The assessment was performed by the Central Reviewer. | Number | participants |
| ||||||||||||||||||||||
| French-American-British (FAB) Classification | FAB is a classification system for five (5) subtypes of myelodysplastic syndrome that are distinguished by the percentage of myeloblasts, presence or absence of ringed sideroblasts or a monocytosis. Classification was made by the Central Reviewer. | Number | participants |
| ||||||||||||||||||||||
| Cytogenetic Complexity | Number | participants |
| |||||||||||||||||||||||
| Eastern Cooperative Oncology Group (ECOG) Performance Status | ECOG indicates a person's ability to perform life's functions on a scale of 0-5: 0= fully active and no restrictions
3-4= increasingly restricted 5= dead | Number | 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 | Participants Who Achieved Red Blood Cell (RBC) -Transfusion Independence | Number of participants who achieved RBC-transfusion independence, which was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive "rolling" 56 days during the treatment period (eg, Days 1 to 56, Days 2 to 57, Days 3 to 58, etc), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. | Modified Intent to Treat (MITT)
| Posted | Number | participants | Up to 2 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Participants With Adverse Experiences | Counts of study participants who had adverse events (AEs) during the study. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. Adverse events were evaluated by the investigator. The National Cancer Institute (NCI)'s Common Toxicity Criteria for AEs (NCI CTC) was used to grade AE severity. Severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. | Safety population included all participants who received at least one dose of study drug. | Posted | Number | participants | Up to 2 Years |
|
| |||||||||||||||||||||||||||
| Secondary | Participants With a >= 50% Decrease From Baseline in Red Blood Cell (RBC) Transfusion Requirements Over Any Consecutive 56 Days During Study | A participant was categorized as having a transfusion reduction response if there was a ≥ 50% decrease from pretreatment transfusion requirements (before the start of the study mediation) compared to any consecutive 56 days during the study (i.e. post treatment). | Modified Intent to Treat (MITT)
| Posted | Number | participant | Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years) |
|
| |||||||||||||||||||||||||||
| Secondary | Time to Transfusion Independence | Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive "rolling" 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Time to transfusion independence was defined as the day of the first dose of study drug to the first day of the first 56-day RBC transfusion-free period. | Modified intent to treat population who achieved transfusion independence | Posted | Mean | Standard Deviation | weeks | up to 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Participants Who Relapsed or Maintained Their Transfusion Independence After Achieving Transfusion Independence During the Study | Transfusion independence was defined as the absence of an intravenous infusion of any RBC transfusion during any consecutive "rolling" 56 days during the treatment period (e.g., Days 1 to 56, Days 2 to 57, Days 3 to 58, etc.), and accompanied by at least a 1 g/dL increase from screening/baseline in hemoglobin. Participants who relapsed required a transfusion after the period of transfusion independence. Participants who maintained transfusion independence did not require a transfusion during the remainder of the study. | Modified intent to treat population who achieved transfusion independence | Posted | Number | participants | up to 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Kaplan Meier Estimate for Duration of Transfusion Independence Response | Duration of response is measured from the first of the consecutive 56 days during which the participant was free of RBC transfusions to the date of the first RBC transfusion after this period. Duration of response was censored at the date of last visit for participants who maintained transfusion independence. | Modified intent to treat population who achieved transfusion independence | Posted | Median | 95% Confidence Interval | weeks | up to 2 years |
|
| ||||||||||||||||||||||||||
| Secondary | Change in Hemoglobin Concentration From Baseline to Maximum Value During Response Period for Responders | The change from baseline in hemoglobin for participants who became RBC-transfusion independent. The maximum hemoglobin value obtained during the response period is used in the calculation of change from baseline. | Modified intent to treat population who achieved transfusion independence | Posted | Mean | Standard Deviation | g/dL | Baseline (Day -54 to Day 0), During study (Day 1 up to 2 years) |
|
| ||||||||||||||||||||||||||
| Secondary | Participant Counts of Cytogenetic Response | Participants deemed evaluable by the central cytogenetic review had their cytogenetic response categorized as major or minor. A major cytogenetic response was defined as ≥ 20 metaphases recorded at baseline, and at least 1 post baseline evaluation with ≥ 20 metaphases analyzed with no abnormal metaphases observed. A minor cytogenetic response was defined as ≥ 20 metaphases analyzed at baseline, and at least 1 post baseline evaluation with ≥ 20 metaphases analyzed with a ≥ 50% reduction in the proportion of hematopoietic cells with cytogenetic abnormalities compared with baseline. | Evaluable participants from the modified intent to treat population. Evaluable participants had ≥ 20 metaphases analyzed at baseline during the 56-day period immediately preceding the first day of study drug intake and ≥ 20 metaphases analyzed at least once at postbaseline visits. | Posted | Number | participants | up to 2 years |
| ||||||||||||||||||||||||||||
| Secondary | Participant Counts of Platelet Response | Major platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3 in all values within 56 days of start of treatment, an absolute increase of ≥30,000/mm^3 sustained for ≥56 consecutive days. In platelet transfusion-dependent participants, a major response was stabilization of platelet counts and platelet transfusion independence. Minor platelet response: participants with a minimum pretreatment platelet of <100,000/mm^3, a ≥ 50% increase in platelet count with a net increase >10,000/mm^3 for a consecutive 56-day period in the absence of platelet transfusions. | Evaluable participants from the modified intent to treat population. Participants must have a baseline platelet count <100 * 10^9/L to be included in the analysis. | Posted | Number | participants | up to 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Participant Counts of Absolute Neutrophil Count (ANC) Response | Major neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3 in all values obtained within 56 days of start of treatment, a ≥ 100% increase or an absolute increase of ≥ 500/mm^3, whichever was greater (at least to be ≥ 500/mm^3), sustained for 56 consecutive days. Minor neutrophil response: participants with a minimum pretreatment ANC concentration of < 1500/mm^3, an increase in ANC concentration of ≥ 100% sustained for 56 consecutive days. | Evaluable participants from the modified intent to treat population. Evaluable participants are required to have a baseline absolute neutrophil count (ANC) <1 * 10^9/L. | Posted | Number | participant | up to 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Participants With Complete or Partial Bone Marrow Improvement | Bone marrow aspirates were assessed by a central reviewer. A complete bone marrow improvement required a baseline French-American-British (FAB) classification (see Baseline Characteristics) of refractory anemia (RA), refractory anemia with ringed sideroblasts (RARS), refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) and a during study assessment of no MDS. A partial bone marrow improvement reflected an improved FAB classification compared to baseline (e.g. RARS to RA) but evidence of MDS continued to exist. | Modified intent to treat population of participants with adequate bone marrow aspirate at baseline. | Posted | Number | participants | up to 2 years |
|
| |||||||||||||||||||||||||||
| Secondary | Participants With Bone Marrow Progression | Bone marrow aspirate was assessed by a central reviewer. Progression is represented in two categories according to changes from baseline in French-American-British (FAB) classification (see Baseline Characteristics):
| Modified intent to treat population of participants with adequate bone marrow aspirate at baseline. | Posted | Number | participants | up to 2 years |
|
|
Up to 2 years
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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 | Lenalidomide | The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen. | 89 | 148 | 148 | 148 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia Not Otherwise Specified (NOS) | Infections and infestations | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Anaemia NOS | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Acute Leukaemia NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cardiac Failure Congestive | Cardiac disorders | Systematic Assessment |
| ||
| Sepsis NOS | Infections and infestations | Systematic Assessment |
| ||
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Deep Vein Thrombosis | Vascular disorders | Systematic Assessment |
| ||
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Vomiting NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal Pain NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Diarrhoea NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Acute Myeloid Leukaemia NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Gastroenteritis NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Leukopenia NOS | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pancytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Bacteraemia | Infections and infestations | Systematic Assessment |
| ||
| Cardiac Failure NOS | Cardiac disorders | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Cerebrovascular Accident | Nervous system disorders | Systematic Assessment |
| ||
| Depressed Level of Consciousness | Nervous system disorders | Systematic Assessment |
| ||
| Dyspnoea NOS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Fall | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Femoral Neck Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Femur Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Infection NOS | Infections and infestations | Systematic Assessment |
| ||
| Medical Device Complication | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Multi-Organ Failure | General disorders | Systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Systematic Assessment |
| ||
| Pleural Effusion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pneumonitis NOS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pulmonary Hypertension NOS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rash NOS | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Rectal Haemorrhage | Gastrointestinal disorders | Systematic Assessment |
| ||
| Renal Failure NOS | Renal and urinary disorders | Systematic Assessment |
| ||
| Syncope | Nervous system disorders | Systematic Assessment |
| ||
| Transient Ischaemic Attack | Nervous system disorders | Systematic Assessment |
| ||
| Urinary Tract Infection NOS | Infections and infestations | Systematic Assessment |
| ||
| Acute Febrile Neutrophilic Dermatosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Aphasia | Nervous system disorders | Systematic Assessment |
| ||
| Arthrlagia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Asthma NOS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Azotaemia | Renal and urinary disorders | Systematic Assessment |
| ||
| B-Cell Lymphoma NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Blood Creatinine Increased | Investigations | Systematic Assessment |
| ||
| Bronchitis Acute NOS | Infections and infestations | Systematic Assessment |
| ||
| Carcinoid Tumour of the Small Bowel | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Cardio-Respiratory Arrest | Cardiac disorders | Systematic Assessment |
| ||
| Cardiomyopathy NOS | Cardiac disorders | Systematic Assessment |
| ||
| Central Line Infection | Infections and infestations | Systematic Assessment |
| ||
| Cerebral Haemorrhage | Nervous system disorders | Systematic Assessment |
| ||
| Cervical Dysplasia | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Chest Pain | General disorders | Systematic Assessment |
| ||
| Cholecystitis NOS | Hepatobiliary disorders | Systematic Assessment |
| ||
| Chronic Obstructive Airways Disease Exacerbated | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Clostridial Infection NOS | Infections and infestations | Systematic Assessment |
| ||
| Coagulopathy | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Colitis Ischaemic | Gastrointestinal disorders | Systematic Assessment |
| ||
| Colonic Polyp | Gastrointestinal disorders | Systematic Assessment |
| ||
| Comminuted Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Convulsions NOS | Nervous system disorders | Systematic Assessment |
| ||
| Dementia NOS | Nervous system disorders | Systematic Assessment |
| ||
| Dermatitis Medicamentosa | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Diastolic Dysfunction | Cardiac disorders | Systematic Assessment |
| ||
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Enterobacter Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Gastritis NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Groin Infection | Infections and infestations | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Herpes Zoster | Infections and infestations | Systematic Assessment |
| ||
| Hiatus Hernia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hip Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Hyperbilirubinaemia | Hepatobiliary disorders | Systematic Assessment |
| ||
| Hypernatraemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypersensitivity NOS | Immune system disorders | Systematic Assessment |
| ||
| Hypertensive Encephalopathy | Nervous system disorders | Systematic Assessment |
| ||
| Hypoglycaemia NOS | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypotension NOS | Vascular disorders | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Intermittent Pyrexia | General disorders | Systematic Assessment |
| ||
| Intestinal Perforation NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Irritable Bowel Syndrome | Gastrointestinal disorders | Systematic Assessment |
| ||
| Klebsiella Sepsis | Infections and infestations | Systematic Assessment |
| ||
| Lobar Pneumonia NOS | Infections and infestations | Systematic Assessment |
| ||
| Localised Osteoarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Lung Cancer Metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Lung Infiltration NOS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Migraine NOS | Nervous system disorders | Systematic Assessment |
| ||
| Multiple Myeloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Oesophageal Perforation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Osteolysis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Ovarian Cancer NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Overdose NOS | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Periarthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Peripheral Ischaemia | Vascular disorders | Systematic Assessment |
| ||
| Perirectal Abscess | Gastrointestinal disorders | Systematic Assessment |
| ||
| Post Procedural Site Wound Infection | Infections and infestations | Systematic Assessment |
| ||
| Pulmonary Oedema NOS | Cardiac disorders | Systematic Assessment |
| ||
| Refractory Anaemia with Excess Blasts in Transformation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Renal Failure Acute | Renal and urinary disorders | Systematic Assessment |
| ||
| Respiratory Distress | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Rigors | General disorders | Systematic Assessment |
| ||
| Senile Dementia NOS | Nervous system disorders | Systematic Assessment |
| ||
| Sinusitis Acute NOS | Infections and infestations | Systematic Assessment |
| ||
| Sinusitis NOS | Infections and infestations | Systematic Assessment |
| ||
| Spinal Compression Fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Subarachnoid Haemorrhage NOS | Nervous system disorders | Systematic Assessment |
| ||
| Subdural Haematoma | Nervous system disorders | Systematic Assessment |
| ||
| Sudden Death | General disorders | Systematic Assessment |
| ||
| Tachyarrhythmia | Cardiac disorders | Systematic Assessment |
| ||
| Thrombophlebitis Superficial | Vascular disorders | Systematic Assessment |
| ||
| Thymoma NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Troponin I Increased | Investigations | Systematic Assessment |
| ||
| Vaginosis Fungal NOS | Infections and infestations | Systematic Assessment |
| ||
| Vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Diarrhoea Not Otherwise Specified (NOS) | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Rash NOS | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Oedema Peripheral | General disorders | Systematic Assessment |
| ||
| Back Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea NOS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pyrexia | General disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Upper Respiratory Tract Infection NOS | Infections and infestations | Systematic Assessment |
| ||
| Anaemia NOS | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Muscle Cramp | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Pain in Limb | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Abdominal Pain NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Asthenia | General disorders | Systematic Assessment |
| ||
| Hypokalaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Dry Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Urinary Tract Infection NOS | Infections and infestations | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Leukopenia NOS | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Sinusitis NOS | Infections and infestations | Systematic Assessment |
| ||
| Contusion | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Oedema NOS | General disorders | Systematic Assessment |
| ||
| Vomiting NOS | Gastrointestinal disorders | Systematic Assessment |
| ||
| Bronchitis NOS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Night Sweats | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Abdominal Pain Upper | Gastrointestinal disorders | Systematic Assessment |
| ||
| Acquired Hypothyroidism | Endocrine disorders | Systematic Assessment |
| ||
| Depression | Psychiatric disorders | Systematic Assessment |
| ||
| Pain NOS | General disorders | Systematic Assessment |
| ||
| Peripheral Swelling | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Fall | General disorders | Systematic Assessment |
| ||
| Hypertension NOS | Vascular disorders | Systematic Assessment |
| ||
| Sweating Increased | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Alanine Aminotransferase Increased | Investigations | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Dry Mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysuria | Renal and urinary disorders | Systematic Assessment |
| ||
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Loose Stools | Gastrointestinal disorders | Systematic Assessment |
| ||
| Rhinitis NOS | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Weight Decreased | Investigations | Systematic Assessment |
| ||
| Chest Pain | General disorders | Systematic Assessment |
| ||
| Hypoaesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Hypomagnesaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Influenza | Infections and infestations | Systematic Assessment |
| ||
| Toothache | Gastrointestinal disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Ecchymosis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Pain in Foot | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Palpitations | Cardiac disorders | Systematic Assessment |
| ||
| Paraesthesia | Nervous system disorders | Systematic Assessment |
| ||
| Peripheral Neuropathy NOS | Nervous system disorders | Systematic Assessment |
| ||
| Conjunctivitis | Eye disorders | Systematic Assessment |
| ||
| Rigors | General disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Appetite Decreased NOS | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Flatulence | Gastrointestinal disorders | Systematic Assessment |
| ||
| Herpes Simplex | Infections and infestations | Systematic Assessment |
| ||
| Hypocalcaemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Neck Pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Peripheral Sensory Neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Skin Lesions NOS | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Vision Blurred | Eye disorders | Systematic Assessment |
|
Unless approved by Celgene, single center data will not be published before multicenter data, unless more than 1 year has elapsed since completion of the Study. Thereafter, Investigator may publish single center data provided that Investigator shall: i) provide a copy of the publication to Celgene at least 60 days in advance of submission for publication; ii) delete Celgene Confidential Information and; iii) delay submission up to 90 additional days to permit intellectual property filings.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials Disclosure | Celgene Corporation | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077269 | Lenalidomide |
| ID | Term |
|---|---|
| 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 |
Not provided
Not provided
| Asian/Pacific Islander |
|
| Title | Measurements |
|---|
|
| Intermediate-2 (1.5 to 2.0) |
|
| High (>=2.5) |
|
| Missing (unable to assign) |
|
| Refractory anemia with excess blasts (RAEB) |
|
| Chronic myelomonocytic leukemia (CMML) |
|
| Acute leukemia |
|
| Unable to classify |
|
| Complex |
|
| Unknown |
|
| 2 |
|
| 3 - 5 |
|
|
|
|
|
|
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Participants |
|
|
|
|
|