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Idarubicin + Cytarabine and Lenalidomide in Patients With Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML)

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ClinicalTrials.gov Identifier: NCT00831766
Recruitment Status : Active, not recruiting
First Posted : January 29, 2009
Results First Posted : March 28, 2016
Last Update Posted : August 6, 2019
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Myelodysplastic Syndrome
Acute Myeloid Leukemia
Interventions Drug: Idarubicin
Drug: Cytarabine
Drug: Lenalidomide (Revlimid®)
Enrollment 51
Recruitment Details Participants were enrolled at Moffitt Cancer Center and Cleveland Clinic between June 2009 and March 2014.
Pre-assignment Details  
Arm/Group Title Phase I: Dose Escalation Phase II: Treatment at MTD
Hide Arm/Group Description

Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.

Idarubicin: 12 mg/m^2.

Cytarabine: 200 mg/m^2.

Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.

Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms.

Idarubicin: 12 mg/m^2.

Cytarabine: 200 mg/m^2.

Lenalidomide: Maximum Tolerated Dose (MTD).

Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms.

Period Title: Overall Study
Started 23 28
Completed 23 28
Not Completed 0 0
Arm/Group Title Phase I: Dose Escalation Phase II: Treatment at MTD Total
Hide Arm/Group Description

Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.

Idarubicin: 12 mg/m^2.

Cytarabine: 200 mg/m^2.

Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.

Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms.

Idarubicin: 12 mg/m^2.

Cytarabine: 200 mg/m^2.

Lenalidomide: Maximum Tolerated Dose (MTD).

Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.

Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms.

Total of all reporting groups
Overall Number of Baseline Participants 23 28 51
Hide Baseline Analysis Population Description
All participants enrolled, according to study phase. Outcome measure groups may vary depending on the analysis required.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 28 participants 51 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
8
  34.8%
5
  17.9%
13
  25.5%
>=65 years
15
  65.2%
23
  82.1%
38
  74.5%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 23 participants 28 participants 51 participants
65
(35 to 79)
70
(60 to 82)
67.7
(35 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 28 participants 51 participants
Female
5
  21.7%
13
  46.4%
18
  35.3%
Male
18
  78.3%
15
  53.6%
33
  64.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 28 participants 51 participants
23 28 51
1.Primary Outcome
Title Phase I: Recommended Phase II Dose
Hide Description For the Phase I component, no formal statistical analysis was planned. The primary endpoint is to determine the maximum tolerated dose (MTD) and recommended Phase II dose of lenalidomide given in combination with standard idarubicin + cytarabine induction therapy.
Time Frame 18 months
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Hide Analysis Population Description
Phase I participants.
Arm/Group Title Phase I Participants
Hide Arm/Group Description:
Dose escalation group.
Overall Number of Participants Analyzed 23
Measure Type: Number
Unit of Measure: mg/day
20
2.Primary Outcome
Title Phase II: Complete Response Rate of Participants Treated at Maximum Tolerated Dose (MTD)
Hide Description Percentage of participants achieving CR/CRi. Complete Response (CR) plus Complete Response with Incomplete Count Recovery (CRi) rates. Response rates (CR + CRi) of lenalidomide following idarubicin and cytarabine induction therapy in older patients with previously untreated AML. A CR designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1,000/μL and platelets of 100,000/μL. CRi: After chemotherapy, patients fulfill all of the criteria for CR except for residual neutropenia (1,000/μL) or thrombocytopenia (100,000/μL).
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated at MTD
Arm/Group Title All Participants Treated at MTD
Hide Arm/Group Description:
All participants, regardless of Phase who were treated at the maximum tolerated dose (MTD).
Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: percentage of participants
54
3.Secondary Outcome
Title Rate of Lenalidomide Related Toxicity During Maintenance Therapy
Hide Description Rate of toxicities of lenalidomide as maintenance therapy according to the National Cancer Institute Common Toxicity Criteria (CTC) V3. Adverse Events: Possibly Related; Probably Related, or Definitely Related to study treatment. Events are categorized as Grade 1 or 2, or as Grade 3 or 4.
Time Frame 24 months
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Hide Analysis Population Description
All Maintenance Phase participants.
Arm/Group Title Maintenance Phase Participants
Hide Arm/Group Description:
All participants treated in the Maintenance Phase.
Overall Number of Participants Analyzed 6
Measure Type: Count of Participants
Unit of Measure: Participants
Leukocytes (total WBC) - low - Grade 1 or 2
1
  16.7%
Leukocytes (total WBC) - low - Grade 3 or 4
0
   0.0%
ANC/AGC - Grade 1 or 2
0
   0.0%
ANC/AGC - Grade 3 or 4
1
  16.7%
Platelets - low - Grade 1 or 2
3
  50.0%
Platelets - low - Grade 3 or 4
0
   0.0%
Fatigue - Grade 1 or 2
1
  16.7%
Fatigue - Grade 3 or 4
0
   0.0%
Dry skin - Grade 1 or 2
1
  16.7%
Dry skin - Grade 3 or 4
0
   0.0%
Pruritus/itching - Grade 1 or 2
1
  16.7%
Pruritus/itching - Grade 3 or 4
0
   0.0%
Rash/desquamation - Grade 1 or 2
2
  33.3%
Rash/desquamation - Grade 3 or 4
0
   0.0%
Constipation - Grade 1 or 2
1
  16.7%
Constipation - Grade 3 or 4
0
   0.0%
Diarrhea - Grade 1 or 2
2
  33.3%
Diarrhea - Grade 3 or 4
0
   0.0%
Nausea - Grade 1 or 2
1
  16.7%
Nausea - Grade 3 or 4
0
   0.0%
Ulcer, GI - Anus - Grade 1 or 2
1
  16.7%
Ulcer, GI - Anus - Grade 3 or 4
0
   0.0%
Hemorrhage, GI - Rectum - Grade 1 or 2
1
  16.7%
Hemorrhage, GI - Rectum - Grade 3 or 4
0
   0.0%
Infection - Skin (cellulitis) Grade 1 or 2
1
  16.7%
Infection - Skin (cellulitis) Grade 3 or 4
0
   0.0%
AST, SGOT - Grade 1 of 2
2
  33.3%
AST, SGOT - Grade 3 or 4
0
   0.0%
Pain - Head/headache - Grade 1 or 2
1
  16.7%
Pain - Head/headache - Grade 3 or 4
0
   0.0%
4.Secondary Outcome
Title Median Progression-Free Survival (PFS)
Hide Description Progression-free survival (PFS), defined as the time from study entry to disease progression, relapse, or death due to any cause, whichever is earlier, will be summarized with the Kaplan-Meier curve.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated at MTD.
Arm/Group Title All Participants Treated at MTD
Hide Arm/Group Description:
All participants, regardless of Phase who were treated at the maximum tolerated dose (MTD).
Overall Number of Participants Analyzed 39
Median (95% Confidence Interval)
Unit of Measure: months
7.55
(5.53 to 10.53)
5.Secondary Outcome
Title Median Overall Survival (OS)
Hide Description Overall Survival (OS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, to be analyzed similarly. Descriptive analysis was planned for this measure.
Time Frame Up to 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
All participants treated at MTD
Arm/Group Title All Participants Treated at MTD
Hide Arm/Group Description:
All participants, regardless of Phase who were treated at the maximum tolerated dose (MTD).
Overall Number of Participants Analyzed 39
Median (95% Confidence Interval)
Unit of Measure: months
11.22
(7.61 to 13.74)
6.Other Pre-specified Outcome
Title Rate of Cytogenetic Remission Following Induction Therapy
Hide Description Rate of cytogenetic remission following induction therapy. Descriptive analysis was planned for this measure.
Time Frame 24 Months
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title Median Relapse-Free Survival (RFS)
Hide Description Relapse-Free Survival (RFS), defined for those patients who have achieved CR or CRi as the time from study entry to disease progression, relapse or death due to any cause, whichever is earlier, will be analyzed similarly. Descriptive analysis was planned for this measure.
Time Frame 24 Months
Outcome Measure Data Not Reported
Time Frame 4 years, 8 months
Adverse Event Reporting Description All Serious Adverse Events (SAEs) are reported, regardless of causality. All Other (not including Serious) Adverse Events (AEs) meeting 5% frequency threshold are reported, regardless of causality.
 
Arm/Group Title Phase I: Dose Escalation Phase II: Treatment at MTD
Hide Arm/Group Description Participants enrolled during Phase I. Participants enrolled during Phase II.
All-Cause Mortality
Phase I: Dose Escalation Phase II: Treatment at MTD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Phase I: Dose Escalation Phase II: Treatment at MTD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/23 (21.74%)      13/28 (46.43%)    
Blood and lymphatic system disorders     
Neutrophils/granulocytes - low  1  0/23 (0.00%)  0 1/28 (3.57%)  1
Platelets - low  1  0/23 (0.00%)  0 2/28 (7.14%)  2
Cardiac disorders     
Cardiac Arrhythmia - Other, atrial fibrilation with rapid ventricular response  1  0/23 (0.00%)  0 1/28 (3.57%)  1
Supraventricular and nodal arrhythmai - atrial fibirillation  1  0/23 (0.00%)  0 1/28 (3.57%)  1
Cardiac ischemia/infarction  1  1/23 (4.35%)  1 0/28 (0.00%)  0
Left ventricular systolic dysfunction  1  1/23 (4.35%)  1 0/28 (0.00%)  0
Gastrointestinal disorders     
Anorexia  1  0/23 (0.00%)  0 1/28 (3.57%)  1
Dehydration  1  0/23 (0.00%)  0 1/28 (3.57%)  1
Diarrhea  1  0/23 (0.00%)  0 2/28 (7.14%)  3
Mucositis/stomatitis - Oral cavity  1  1/23 (4.35%)  1 0/28 (0.00%)  0
General disorders     
Fever (in the absence of neutropenia)  1  1/23 (4.35%)  1 1/28 (3.57%)  1
Death - Disease progression NOS  1  1/23 (4.35%)  1 0/28 (0.00%)  0
Death - Multi-organ failure  1  1/23 (4.35%)  1 0/28 (0.00%)  0
Pain - Extremity, limb  1  1/23 (4.35%)  1 0/28 (0.00%)  0
Infections and infestations     
Febrile neutropenia  1  1/23 (4.35%)  1 9/28 (32.14%)  9
Infection with Grade 3 or 4 neutrophils - abdomen, NOS  1  0/23 (0.00%)  0 1/28 (3.57%)  1
Infection with Grade 3 or 4 neutrophils - Blood  1  0/23 (0.00%)  0 5/28 (17.86%)  5
Infection with Grade 3 or 4 neutrophils - Lung (pneumonia)  1  0/23 (0.00%)  0 1/28 (3.57%)  1
Infection with normal ANC or Grade 1 or 2 neutrophnils - Gallbladder (cholecystitis)  1  0/23 (0.00%)  0 1/28 (3.57%)  1
Infection with Grade 3 or 4 Neutrophils - Urinary Tract  1  0/23 (0.00%)  0 1/28 (3.57%)  1
Metabolism and nutrition disorders     
AST, SGOT - high  1  1/23 (4.35%)  1 0/28 (0.00%)  0
Nervous system disorders     
Confusion  1  0/23 (0.00%)  0 1/28 (3.57%)  1
Renal and urinary disorders     
Renal/Genitourinary - Other, acute kidney injury  1  0/23 (0.00%)  0 1/28 (3.57%)  1
Respiratory, thoracic and mediastinal disorders     
Hypoxia  1  1/23 (4.35%)  1 0/28 (0.00%)  0
Vascular disorders     
Thrombosis/embolism (vascular access-related)  1  0/23 (0.00%)  0 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Phase I: Dose Escalation Phase II: Treatment at MTD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/23 (95.65%)      26/28 (92.86%)    
Blood and lymphatic system disorders     
Platelets - low  1  16/23 (69.57%)  22 17/28 (60.71%)  40
Hemoglobin - low  1  9/23 (39.13%)  16 18/28 (64.29%)  31
Neutrophils/granulocytes - low  1  10/23 (43.48%)  12 14/28 (50.00%)  30
Leukocytes (total WBC) - low  1  2/23 (8.70%)  4 6/28 (21.43%)  16
Edema: limb  1  8/23 (34.78%)  11 18/28 (64.29%)  29
Edema: head and neck  1  0/23 (0.00%)  0 4/28 (14.29%)  4
Lymphatics - Other, fluid retention  1  1/23 (4.35%)  1 2/28 (7.14%)  2
Cardiac disorders     
Hypotension  1  3/23 (13.04%)  4 8/28 (28.57%)  9
Hypertension  1  2/23 (8.70%)  2 7/28 (25.00%)  8
Pericardial effusion (non-malignant)  1  2/23 (8.70%)  2 0/28 (0.00%)  0
Ventricular arrhythmia - Ventricular tachycardia  1  0/23 (0.00%)  0 6/28 (21.43%)  8
Supraventricular and nodal arrhythmia - Sinus bradycardia  1  3/23 (13.04%)  3 2/28 (7.14%)  2
Supraventricular and nodal arrhythmia - Sinus tachycardia  1  1/23 (4.35%)  1 2/28 (7.14%)  2
Supraventricular and nodal arrhythmia - Atrial fibrillation  1  2/23 (8.70%)  2 0/28 (0.00%)  0
Eye disorders     
Dry eye syndrome  1  2/23 (8.70%)  2 1/28 (3.57%)  1
Vision-blurred vision  1  0/23 (0.00%)  0 3/28 (10.71%)  3
Gastrointestinal disorders     
Diarrhea  1  19/23 (82.61%)  31 25/28 (89.29%)  41
Nausea  1  12/23 (52.17%)  16 16/28 (57.14%)  33
Constipation  1  7/23 (30.43%)  7 17/28 (60.71%)  19
Anorexia  1  6/23 (26.09%)  7 16/28 (57.14%)  23
Mucositis/stomatitis (clinical exam) - Oral cavity  1  9/23 (39.13%)  11 13/28 (46.43%)  18
Vomiting  1  7/23 (30.43%)  8 15/28 (53.57%)  17
Distension/bloating, abdominal  1  1/23 (4.35%)  1 11/28 (39.29%)  17
Dry mouth/salivary gland (xerostomia)  1  1/23 (4.35%)  1 7/28 (25.00%)  7
Gastrointestinal - Other, GERD  1  0/23 (0.00%)  0 3/28 (10.71%)  3
Taste alteration (dysgeusia)  1  1/23 (4.35%)  1 5/28 (17.86%)  5
Heartburn/dyspepsia  1  2/23 (8.70%)  4 5/28 (17.86%)  11
Hemorrhoids  1  0/23 (0.00%)  0 5/28 (17.86%)  6
Colitis  1  2/23 (8.70%)  2 1/28 (3.57%)  1
Enteritis (inflammation of the small bowel)  1  2/23 (8.70%)  2 1/28 (3.57%)  1
Flatulence  1  0/23 (0.00%)  0 2/28 (7.14%)  2
Hemorrhage, G I- Oral cavity  1  2/23 (8.70%)  2 0/28 (0.00%)  0
General disorders     
Pain - Abdomen NOS  1  10/23 (43.48%)  13 7/28 (25.00%)  9
Pain - Head/headache  1  1/23 (4.35%)  1 11/28 (39.29%)  12
Pain - Chest wall  1  3/23 (13.04%)  3 7/28 (25.00%)  8
Pain - back  1  2/23 (8.70%)  2 6/28 (21.43%)  6
Pain - Throat/pharynx/larynx  1  2/23 (8.70%)  3 6/28 (21.43%)  7
Pain - Chest/thorax NOS  1  1/23 (4.35%)  1 5/28 (17.86%)  5
Pain - Extremity-limb  1  1/23 (4.35%)  2 2/28 (7.14%)  3
Pain - Oral cavity  1  0/23 (0.00%)  0 3/28 (10.71%)  3
Fatigue  1  5/23 (21.74%)  6 14/28 (50.00%)  16
Rigors/chills  1  3/23 (13.04%)  4 13/28 (46.43%)  20
Insomnia  1  3/23 (13.04%)  3 10/28 (35.71%)  11
Fever (in the absence of neutropenia)  1  5/23 (21.74%)  6 14/28 (50.00%)  16
Sweating (diaphoresis)  1  1/23 (4.35%)  1 5/28 (17.86%)  6
Weight loss  1  3/23 (13.04%)  3 2/28 (7.14%)  2
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)  1  0/23 (0.00%)  0 2/28 (7.14%)  2
Infections and infestations     
Febrile neutropenia  1  14/23 (60.87%)  22 22/28 (78.57%)  39
Infection with Grade 3 or 4 neutrophils - Lung (pneumonia)  1  9/23 (39.13%)  12 5/28 (17.86%)  5
Infection with Grade 3 or 4 neutrophils - Blood  1  0/23 (0.00%)  0 9/28 (32.14%)  10
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)  1  1/23 (4.35%)  1 3/28 (10.71%)  3
Infection with Grade 3 or 4 neutrophils - Abdomen NOS  1  1/23 (4.35%)  1 2/28 (7.14%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood  1  2/23 (8.70%)  2 1/28 (3.57%)  2
Infection with Grade 3 or 4 neutrophils - Bladder (urinary)  1  0/23 (0.00%)  0 2/28 (7.14%)  2
Infection with unknown ANC - Anal/perianal  1  0/23 (0.00%)  0 2/28 (7.14%)  2
Infection with unknown ANC - Lung (pneumonia)  1  1/23 (4.35%)  1 2/28 (7.14%)  2
Infection with unknown ANC - Skin (cellulitis)  1  0/23 (0.00%)  0 3/28 (10.71%)  3
Metabolism and nutrition disorders     
ALT, SGPT - high  1  5/23 (21.74%)  6 7/28 (25.00%)  12
Bilirubin (hyperbilirubinemia)  1  4/23 (17.39%)  4 7/28 (25.00%)  11
Potassium, serum-low (hypokalemia)  1  4/23 (17.39%)  11 5/28 (17.86%)  5
Calcium, serum-low (hypocalcemia)  1  4/23 (17.39%)  5 6/28 (21.43%)  8
Sodium, serum-low (hyponatremia)  1  5/23 (21.74%)  7 3/28 (10.71%)  3
Albumin, serum-low (hypoalbuminemia)  1  6/23 (26.09%)  6 4/28 (14.29%)  8
AST, SGOT - high  1  3/23 (13.04%)  4 6/28 (21.43%)  7
Magnesium, serum-low (hypomagnesemia)  1  6/23 (26.09%)  8 2/28 (7.14%)  4
Potassium, serum-high (hyperkalemia)  1  6/23 (26.09%)  12 1/28 (3.57%)  1
Alkaline phosphatase - increased  1  3/23 (13.04%)  5 2/28 (7.14%)  4
Glucose, serum-high (hyperglycemia)  1  2/23 (8.70%)  2 3/28 (10.71%)  3
Creatinine - high  1  3/23 (13.04%)  4 0/28 (0.00%)  0
Phosphate, serum-low (hypophosphatemia)  1  0/23 (0.00%)  0 2/28 (7.14%)  2
Tumor lysis syndrome  1  2/23 (8.70%)  2 0/28 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle weakness, generalized or specific area (not due to neuropathy) - Whole body/generalized  1  4/23 (17.39%)  6 6/28 (21.43%)  6
Nervous system disorders     
Dizziness  1  4/23 (17.39%)  5 12/28 (42.86%)  17
Confusion  1  1/23 (4.35%)  2 4/28 (14.29%)  4
Syncope (fainting)  1  2/23 (8.70%)  2 2/28 (7.14%)  2
Extrapyramidal/involuntary movement/restlessness  1  0/23 (0.00%)  0 2/28 (7.14%)  2
Memory impairment  1  0/23 (0.00%)  0 2/28 (7.14%)  2
Psychiatric disorders     
Mood alteration - Anxiety  1  4/23 (17.39%)  4 8/28 (28.57%)  8
Psychosis (hallucinations/delusions)  1  0/23 (0.00%)  0 6/28 (21.43%)  6
Mental status - Change  1  0/23 (0.00%)  0 4/28 (14.29%)  4
Renal and urinary disorders     
Renal/Genitourinary - Other, acute kidney injury  1  2/23 (8.70%)  2 0/28 (0.00%)  0
Renal failure  1  2/23 (8.70%)  2 0/28 (0.00%)  0
Urinary frequency/urgency  1  0/23 (0.00%)  0 3/28 (10.71%)  3
Urinary retention (including neurogenic bladder)  1  0/23 (0.00%)  0 2/28 (7.14%)  2
Renal/Genitourinary - Other, hematuria  1  3/23 (13.04%)  3 0/28 (0.00%)  0
Renal/Genitourinary - Other, renal insufficiency  1  2/23 (8.70%)  2 1/28 (3.57%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  8/23 (34.78%)  8 15/28 (53.57%)  19
Dyspnea (shortness of breath)  1  3/23 (13.04%)  3 13/28 (46.43%)  16
Pleural effusion (non-malignant)  1  4/23 (17.39%)  4 8/28 (28.57%)  8
Pulmonary/Upper Respiratory - Other, respiratory failure  1  1/23 (4.35%)  1 2/28 (7.14%)  2
Hypoxia  1  1/23 (4.35%)  1 5/28 (17.86%)  5
Bronchospasm, wheezing  1  0/23 (0.00%)  0 5/28 (17.86%)  5
Nasal cavity/paranasal sinus reactions  1  0/23 (0.00%)  0 4/28 (14.29%)  4
Pneumonitis/pulmonary infiltrates  1  2/23 (8.70%)  2 2/28 (7.14%)  2
Hemorrhage, pulmonary/upper respiratory - Nose  1  5/23 (21.74%)  6 9/28 (32.14%)  11
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS  1  0/23 (0.00%)  0 2/28 (7.14%)  2
Allergic rhinitis  1  1/23 (4.35%)  1 4/28 (14.29%)  4
Skin and subcutaneous tissue disorders     
Rash/desquamation  1  14/23 (60.87%)  25 19/28 (67.86%)  35
Pruritus/itching  1  6/23 (26.09%)  6 14/28 (50.00%)  18
Ulceration  1  0/23 (0.00%)  0 6/28 (21.43%)  9
Rash: erythema multiforme  1  0/23 (0.00%)  0 5/28 (17.86%)  5
Dry skin  1  0/23 (0.00%)  0 4/28 (14.29%)  4
Rash: acne/acneiform  1  2/23 (8.70%)  2 2/28 (7.14%)  2
Hair loss/alopecia (scalp or body)  1  0/23 (0.00%)  0 2/28 (7.14%)  2
Infection with Grade 3 or 4 neutrophils - Skin (cellulitis)  1  2/23 (8.70%)  2 4/28 (14.29%)  4
Infection with unknown ANC - Skin (cellulitis)  1  0/23 (0.00%)  0 2/28 (7.14%)  2
Infection with Grade 3 or 4 neutrophils - Anal/perianal  1  0/23 (0.00%)  0 2/28 (7.14%)  2
Petechiae/purpura (hrmorrhage/bldding into skin or mucosa)  1  3/23 (13.04%)  3 3/28 (10.71%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jeffrey Lancet
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-1387
EMail: jeffrey.lancet@moffitt.org
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00831766     History of Changes
Other Study ID Numbers: MCC-15625
RV-AML/MDS-PI-0269 ( Other Identifier: Celgene )
First Submitted: January 28, 2009
First Posted: January 29, 2009
Results First Submitted: February 25, 2016
Results First Posted: March 28, 2016
Last Update Posted: August 6, 2019