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Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00114101
Recruitment Status : Active, not recruiting
First Posted : June 14, 2005
Results First Posted : July 1, 2013
Last Update Posted : August 14, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions DS Stage I Plasma Cell Myeloma
DS Stage II Plasma Cell Myeloma
DS Stage III Plasma Cell Myeloma
Refractory Plasma Cell Myeloma
Smoldering Plasma Cell Myeloma
Interventions Procedure: Autologous Hematopoietic Stem Cell Transplantation
Other: Laboratory Biomarker Analysis
Drug: Lenalidomide
Drug: Melphalan
Procedure: Peripheral Blood Stem Cell Transplantation
Other: Placebo
Enrollment 460

Recruitment Details From December 2004 and July 2009, a total of 568 participants were recruited to this study.
Pre-assignment Details After registration, participants underwent a peripheral blood stem cell transplant. Of the 568 participants, 460 were randomized to either arm, stratified by beta2 microglobulin, prior thalidomide use and prior lenalidomide use. (108 participants dropped out prior to randomization, most common reasons include: progression, ineligible, refusal)
Arm/Group Title Lenalidomide Maintenance Placebo Maintenance
Hide Arm/Group Description Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

(closed as of 12/17/09)

Period Title: Overall Study
Started 231 229
Completed 231 229
Not Completed 0 0
Arm/Group Title Lenalidomide Maintenance Placebo Maintenance Total
Hide Arm/Group Description Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

(closed as of 12/17/09)

Total of all reporting groups
Overall Number of Baseline Participants 231 229 460
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 231 participants 229 participants 460 participants
59
(29 to 71)
58
(40 to 71)
59
(29 to 71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 231 participants 229 participants 460 participants
Female
110
  47.6%
100
  43.7%
210
  45.7%
Male
121
  52.4%
129
  56.3%
250
  54.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 231 participants 229 participants 460 participants
231 229 460
Beta 2 microglobulin at registration  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 231 participants 229 participants 460 participants
> 2.5 mg/liter 50 55 105
<= 2.5 mg/liter 170 163 333
Missing data 11 11 22
Prior use of thalidomide during induction  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 231 participants 229 participants 460 participants
Yes 102 103 205
No 129 126 255
Prior use of lenalidomide during induction therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 231 participants 229 participants 460 participants
Yes 79 81 160
No 152 148 300
1.Primary Outcome
Title Time to Progression
Hide Description

Time to progression (TTP) was defined as the date of transplant to date of progression or death due to any cause, whichever occurs first. TTP was estimated using the Kaplan Meier method.

Progression was defined per the International Myeloma Working Group definition as one more of the following:

  • 25% increase in serum M-component (absolute increase >= 0.5g/dl)
  • 25% increase in urine M-component (absolute increase >= 200mg/24hour
  • 25% increase in the difference between involved and uninvolved Free Light Chain levels (absolute increase >= 10mg/dl)
  • 25 % increase in bone marrow plasma cell percentage (absolute increase of >=10%)
  • Definite development of new bone lesion or soft tissue plasmacytomas
  • Development of hypercalcemia
Time Frame Duration of study (up to 10years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide Maintenance Placebo Maintenance
Hide Arm/Group Description:
Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

(closed as of 12/17/09)

Overall Number of Participants Analyzed 231 229
Median (95% Confidence Interval)
Unit of Measure: months
39 [1] 
(36 to NA)
21
(18 to 28)
[1]
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Maintenance, Placebo Maintenance
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments This study was designed to have 80% power, with the use of the log-rank test at a one-sided significance level of 0.05, to detect a hazard ratio of 1.4, assuming proportional hazards and an exponential time to event distribution. Under the assumed framework, 309 events were expected. The expected drop out rate before randomization was 15%.
Statistical Test of Hypothesis P-Value <0.001
Comments Participants were randomized with the use of a permuted-block design stratified by beta 2 microglobulin, prior use of thalidomide and prior use of lenalidomide. TTP was monitored with the use of a group sequential design for superiority and futility.
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.36
Confidence Interval (2-Sided) 95%
0.26 to 0.53
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
Hide Description

Response was defined according to International Myeloma Working Group criteria (2006)

  • Complete Response: Complete disappearance of M-protein from serum & urine on immunofixation, normalization of Free Light Chain (FLC) ratio & <5% plasma cells in bone marrow (BM)
  • Partial Response: >= 50% reduction in serum M-Component and/or Urine M-Component >= 90% reduction or <200 mg per 24 hours; or >= 50% decrease in difference between involved and uninvolved FLC levels
  • Marginal Response: 25-49% reduction in serum M-component & urine M-component by 50-89% which still exceeds 200mg/24hour
  • Progressive Disease: Defined in primary outcome measure
  • Stable Disease: Not meeting any of the criteria above
Time Frame Day 100
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide Maintenance Placebo Maintenance
Hide Arm/Group Description:
Beginning between day 100-110, patients receive oral lenalidomide once daily.

Beginning between day 100-110, patients receive oral placebo once daily.

(closed as of 12/17/09)

Overall Number of Participants Analyzed 231 229
Measure Type: Number
Unit of Measure: participants
Complete response 67 79
Partial response 115 109
Marginal response 11 5
Stable disease 38 32
Progressive disease 0 3
Unknown 0 1
3.Other Pre-specified Outcome
Title Overall Survival
Hide Description Overall Survival was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.
Time Frame Duration of study (up to 10 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide Maintenance Placebo Maintenance
Hide Arm/Group Description:
Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

(closed as of 12/17/09)

Overall Number of Participants Analyzed 231 229
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
The median overall survival has not been reached.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Maintenance, Placebo Maintenance
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.52
Confidence Interval (2-Sided) 95%
0.26 to 1.02
Estimation Comments [Not Specified]
4.Post-Hoc Outcome
Title Number of Participants With Progression, Death or Diagnosis of Second Primary Malignancy
Hide Description Patients who develop progression (defined in primary outcome measure), died or develop a new primary malignancy (cancer) will summarized in this outcome.
Time Frame Duration of study (up to 10 years)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide Maintenance Placebo Maintenance
Hide Arm/Group Description:
Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

(closed as of 12/17/09)

Overall Number of Participants Analyzed 231 229
Measure Type: Number
Unit of Measure: participants
92 133
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lenalidomide Maintenance, Placebo Maintenance
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.53
Confidence Interval (2-Sided) 95%
0.41 to 0.69
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide Maintenance Placebo Maintenance
Hide Arm/Group Description Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.

(closed as of 12/17/09)

All-Cause Mortality
Lenalidomide Maintenance Placebo Maintenance
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide Maintenance Placebo Maintenance
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   52/231 (22.51%)      33/229 (14.41%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  6/231 (2.60%)  6 2/229 (0.87%)  2
Hemoglobin  1  8/231 (3.46%)  8 5/229 (2.18%)  5
Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Cardiac disorders     
Cardiac Arrhythmia - Other  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Cardiac ischemia/infarction  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Conduction abnormality/atrioventricular heart block  1  1/231 (0.43%)  1 2/229 (0.87%)  2
Left ventricular systolic dysfunction  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Restrictive cardiomyopathy  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Supraventricular and nodal arrhythmia  1  1/231 (0.43%)  1 2/229 (0.87%)  2
Endocrine disorders     
Thyroid function high (hyperthyroidism thyrotoxicosis)  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Thyroid function, low (hypothyroidism)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Eye disorders     
Cataract  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Ocular/Visual - Other  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Diarrhea  1  19/231 (8.23%)  22 9/229 (3.93%)  9
Distension/bloating, abdominal  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Esophagitis  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Gastrointestinal - Other  1  1/231 (0.43%)  1 2/229 (0.87%)  2
Heartburn/dyspepsia  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Hemorrhage, GI  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Nausea  1  5/231 (2.16%)  5 4/229 (1.75%)  4
Obstruction GI  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Pancreatitis  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Ulcer, GI  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Vomiting  1  1/231 (0.43%)  1 3/229 (1.31%)  3
General disorders     
Constitutional Symptoms - Other  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Death not associated with CTCAE term  1  2/231 (0.87%)  2 2/229 (0.87%)  2
Edema: limb  1  1/231 (0.43%)  1 2/229 (0.87%)  2
Fatigue (asthenia, lethargy, malaise)  1  3/231 (1.30%)  3 2/229 (0.87%)  2
Fever  1  3/231 (1.30%)  3 4/229 (1.75%)  4
Pain - Other  1  1/231 (0.43%)  1 2/229 (0.87%)  2
Rigors/chills  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Hepatobiliary disorders     
Liver dysfunction/failure (clinical)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Infections and infestations     
Colitis, infectious (e.g., Clostridium difficile)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Infection  1  16/231 (6.93%)  18 7/229 (3.06%)  7
Infection - Other  1  4/231 (1.73%)  4 1/229 (0.44%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils  1  14/231 (6.06%)  14 9/229 (3.93%)  13
Infection with unknown ANC  1  0/231 (0.00%)  0 7/229 (3.06%)  8
Infection without neutropenia  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Injury, poisoning and procedural complications     
Fracture  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Thrombosis/embolism (vascular access-related)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Investigations     
ALT, SGPT (serum glutamic pyruvic transaminase)  1  3/231 (1.30%)  3 1/229 (0.44%)  1
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  4/231 (1.73%)  4 1/229 (0.44%)  1
Alkaline phosphatase  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Bilirubin (hyperbilirubinemia)  1  10/231 (4.33%)  12 4/229 (1.75%)  5
Cardiac troponin I (cTnI)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Creatinine  1  1/231 (0.43%)  2 3/229 (1.31%)  3
Fibrinogen  1  0/231 (0.00%)  0 1/229 (0.44%)  1
INR (International Normalized Ratio of prothrombin time)  1  2/231 (0.87%)  2 1/229 (0.44%)  1
Leukocytes (total WBC)  1  10/231 (4.33%)  11 2/229 (0.87%)  2
Lipase  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Lymphopenia  1  5/231 (2.16%)  5 3/229 (1.31%)  3
Metabolic/Laboratory - Other  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Neutrophils/granulocytes (ANC/AGC)  1  40/231 (17.32%)  47 14/229 (6.11%)  16
PTT (Partial Thromboplastin Time)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Platelets  1  39/231 (16.88%)  45 16/229 (6.99%)  21
Weight gain  1  1/231 (0.43%)  1 3/229 (1.31%)  3
Metabolism and nutrition disorders     
Acidosis (metabolic or respiratory)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Albumin, serum-low (hypoalbuminemia)  1  2/231 (0.87%)  2 3/229 (1.31%)  3
Anorexia  1  2/231 (0.87%)  2 1/229 (0.44%)  1
Calcium serum-high (hypercalcemia)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Calcium serum-low (hypocalcemia)  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Dehydration  1  1/231 (0.43%)  1 4/229 (1.75%)  4
Glucose serum-high (hyperglycemia)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Glucose serum-low (hypoglycemia)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Magnesium serum-low (hypomagnesemia)  1  1/231 (0.43%)  1 2/229 (0.87%)  2
Phosphate serum-low (hypophosphatemia)  1  3/231 (1.30%)  4 3/229 (1.31%)  3
Potassium serum-high (hyperkalemia)  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Potassium serum-low (hypokalemia)  1  3/231 (1.30%)  3 3/229 (1.31%)  3
Sodium serum-low (hyponatremia)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Musculoskeletal and connective tissue disorders     
Osteonecrosis (avascular necrosis)  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Pain  1  6/231 (2.60%)  8 9/229 (3.93%)  12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Secondary Malignancy - possibly related to cancer treatment  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Nervous system disorders     
CNS cerebrovascular ischemia  1  1/231 (0.43%)  1 2/229 (0.87%)  2
Dizziness  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Memory impairment  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Mental status  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Neurology - Other  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Neuropathy: motor  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Neuropathy: sensory  1  1/231 (0.43%)  1 2/229 (0.87%)  2
Seizure  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Somnolence/depressed level of consciousness  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Syncope (fainting)  1  2/231 (0.87%)  2 2/229 (0.87%)  2
Psychiatric disorders     
Confusion  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Mood alteration  1  4/231 (1.73%)  4 1/229 (0.44%)  1
Renal and urinary disorders     
Renal failure  1  1/231 (0.43%)  2 2/229 (0.87%)  3
Respiratory, thoracic and mediastinal disorders     
Adult Respiratory Distress Syndrome (ARDS)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Cough  1  3/231 (1.30%)  3 2/229 (0.87%)  2
Dyspnea (shortness of breath)  1  3/231 (1.30%)  3 5/229 (2.18%)  5
Hypoxia  1  3/231 (1.30%)  3 3/229 (1.31%)  4
Pneumonitis/pulmonary infiltrates  1  3/231 (1.30%)  4 4/229 (1.75%)  5
Pulmonary/Upper Respiratory - Other  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Skin and subcutaneous tissue disorders     
Pruritus/itching  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Rash/desquamation  1  6/231 (2.60%)  6 4/229 (1.75%)  5
Rash: hand-foot skin reaction  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Vascular disorders     
Hypertension  1  0/231 (0.00%)  0 3/229 (1.31%)  3
Hypotension  1  1/231 (0.43%)  1 2/229 (0.87%)  2
Thrombosis/thrombus/embolism  1  2/231 (0.87%)  2 1/229 (0.44%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lenalidomide Maintenance Placebo Maintenance
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   195/231 (84.42%)      166/229 (72.49%)    
Blood and lymphatic system disorders     
Blood/Bone Marrow - Other  1  2/231 (0.87%)  4 1/229 (0.44%)  1
Febrile neutropenia  1  9/231 (3.90%)  10 3/229 (1.31%)  4
Hemoglobin  1  26/231 (11.26%)  45 9/229 (3.93%)  22
Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Cardiac disorders     
Cardiac General - Other  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Conduction abnormality/atrioventricular heart block  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Edema  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Left ventricular systolic dysfunction  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Palpitations  1  2/231 (0.87%)  2 1/229 (0.44%)  1
Supraventricular and nodal arrhythmia  1  3/231 (1.30%)  3 1/229 (0.44%)  1
Ventricular arrhythmia  1  0/231 (0.00%)  0 1/229 (0.44%)  2
Ear and labyrinth disorders     
Hearing: patients without baseline audiogram and not enrolled in a monitoring program  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Tinnitus  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Endocrine disorders     
Thyroid function high (hyperthyroidism thyrotoxicosis)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Thyroid function, low (hypothyroidism)  1  1/231 (0.43%)  2 2/229 (0.87%)  2
Eye disorders     
Cataract  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Ocular/Visual - Other  1  0/231 (0.00%)  0 4/229 (1.75%)  4
Vision-blurred vision  1  1/231 (0.43%)  1 1/229 (0.44%)  2
Watery eye (epiphora tearing)  1  0/231 (0.00%)  0 2/229 (0.87%)  3
Gastrointestinal disorders     
Colitis  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Constipation  1  9/231 (3.90%)  10 7/229 (3.06%)  12
Dental: periodontal disease  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Diarrhea  1  89/231 (38.53%)  227 52/229 (22.71%)  90
Distension/bloating, abdominal  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Dry mouth/salivary gland (xerostomia)  1  1/231 (0.43%)  2 3/229 (1.31%)  4
Dysphagia (difficulty swallowing)  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Esophagitis  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Gastritis (including bile reflux gastritis)  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Gastrointestinal - Other  1  3/231 (1.30%)  3 1/229 (0.44%)  1
Heartburn/dyspepsia  1  3/231 (1.30%)  3 0/229 (0.00%)  0
Hemorrhage, GI  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Hemorrhoids  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Melena/GI bleeding  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Mucositis/stomatitis (clinical exam)  1  2/231 (0.87%)  2 1/229 (0.44%)  1
Mucositis/stomatitis (functional/symptomatic)  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Nausea  1  13/231 (5.63%)  15 10/229 (4.37%)  15
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies if specified in the protocol.  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Vomiting  1  9/231 (3.90%)  10 6/229 (2.62%)  9
General disorders     
Constitutional Symptoms - Other  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Edema: limb  1  4/231 (1.73%)  5 3/229 (1.31%)  3
Edema:head and neck  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Fatigue (asthenia, lethargy, malaise)  1  36/231 (15.58%)  55 29/229 (12.66%)  54
Fever  1  9/231 (3.90%)  10 2/229 (0.87%)  2
Flu-like syndrome  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Pain - Other  1  1/231 (0.43%)  1 8/229 (3.49%)  14
Rigors/chills  1  4/231 (1.73%)  6 1/229 (0.44%)  3
Syndromes - Other  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Hepatobiliary disorders     
Cholecystitis  1  2/231 (0.87%)  2 0/229 (0.00%)  0
Immune system disorders     
Allergic reaction/hypersensitivity (including drug fever)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Allergy/Immunology - Other  1  2/231 (0.87%)  2 0/229 (0.00%)  0
Infections and infestations     
Infection  1  16/231 (6.93%)  17 11/229 (4.80%)  14
Infection - Other  1  6/231 (2.60%)  6 3/229 (1.31%)  3
Infection with normal ANC or Grade 1 or 2 neutrophils  1  11/231 (4.76%)  14 14/229 (6.11%)  18
Infection with unknown ANC  1  15/231 (6.49%)  18 9/229 (3.93%)  11
Infection without neutropenia  1  2/231 (0.87%)  3 1/229 (0.44%)  1
Opportunistic infection associated with >=Grade 2 Lymphopenia  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Viral hepatitis  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Injury, poisoning and procedural complications     
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Burn  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Fracture  1  1/231 (0.43%)  1 2/229 (0.87%)  2
Intra-operative injury  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Investigations     
ALT, SGPT (serum glutamic pyruvic transaminase)  1  11/231 (4.76%)  13 2/229 (0.87%)  3
AST, SGOT(serum glutamic oxaloacetic transaminase)  1  7/231 (3.03%)  8 3/229 (1.31%)  5
Alkaline phosphatase  1  5/231 (2.16%)  5 4/229 (1.75%)  4
Bilirubin (hyperbilirubinemia)  1  24/231 (10.39%)  66 18/229 (7.86%)  36
CPK (creatine phosphokinase)  1  1/231 (0.43%)  3 0/229 (0.00%)  0
Creatinine  1  2/231 (0.87%)  2 5/229 (2.18%)  9
GGT (gamma-Glutamyl transpeptidase)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
INR (International Normalized Ratio of prothrombin time)  1  3/231 (1.30%)  7 0/229 (0.00%)  0
Leukocytes (total WBC)  1  29/231 (12.55%)  72 14/229 (6.11%)  33
Lymphopenia  1  17/231 (7.36%)  31 9/229 (3.93%)  23
Metabolic/Laboratory - Other  1  2/231 (0.87%)  3 3/229 (1.31%)  4
Neutrophils/granulocytes (ANC/AGC)  1  153/231 (66.23%)  593 75/229 (32.75%)  181
PTT (Partial Thromboplastin Time)  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Platelets  1  129/231 (55.84%)  445 78/229 (34.06%)  200
Weight gain  1  13/231 (5.63%)  21 21/229 (9.17%)  33
Weight loss  1  1/231 (0.43%)  2 1/229 (0.44%)  1
Metabolism and nutrition disorders     
Albumin, serum-low (hypoalbuminemia)  1  1/231 (0.43%)  1 2/229 (0.87%)  2
Anorexia  1  5/231 (2.16%)  5 6/229 (2.62%)  7
Calcium serum-high (hypercalcemia)  1  0/231 (0.00%)  0 2/229 (0.87%)  3
Calcium serum-low (hypocalcemia)  1  6/231 (2.60%)  6 5/229 (2.18%)  6
Dehydration  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Glucose serum-high (hyperglycemia)  1  8/231 (3.46%)  12 7/229 (3.06%)  18
Glucose serum-low (hypoglycemia)  1  3/231 (1.30%)  3 1/229 (0.44%)  2
Phosphate serum-low (hypophosphatemia)  1  2/231 (0.87%)  2 3/229 (1.31%)  4
Potassium serum-high (hyperkalemia)  1  3/231 (1.30%)  3 1/229 (0.44%)  1
Potassium serum-low (hypokalemia)  1  9/231 (3.90%)  11 4/229 (1.75%)  7
Sodium serum-low (hyponatremia)  1  2/231 (0.87%)  2 1/229 (0.44%)  1
Triglyceride serum-high (hypertriglyceridemia)  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Uric acid serum-high (hyperuricemia)  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Musculoskeletal and connective tissue disorders     
Arthritis (non-septic)  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Joint-function  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Lumbar spine-range of motion  1  0/231 (0.00%)  0 1/229 (0.44%)  2
Muscle weakness, generalized or specific area (not due to neuropathy)  1  1/231 (0.43%)  1 2/229 (0.87%)  3
Musculoskeletal/Soft Tissue - Other  1  0/231 (0.00%)  0 4/229 (1.75%)  4
Myositis (inflammation/damage of muscle)  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Pain  1  35/231 (15.15%)  84 50/229 (21.83%)  154
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Secondary Malignancy - possibly related to cancer treatment  1  5/231 (2.16%)  5 1/229 (0.44%)  1
Nervous system disorders     
Ataxia (incoordination)  1  2/231 (0.87%)  3 0/229 (0.00%)  0
Dizziness  1  4/231 (1.73%)  8 8/229 (3.49%)  9
Headache  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Hemorrhage CNS  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Memory impairment  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Neurology - Other  1  1/231 (0.43%)  1 4/229 (1.75%)  4
Neuropathy: cranial  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Neuropathy: motor  1  6/231 (2.60%)  10 4/229 (1.75%)  6
Neuropathy: sensory  1  24/231 (10.39%)  40 24/229 (10.48%)  49
Somnolence/depressed level of consciousness  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Speech impairment (e.g., dysphasia or aphasia)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Syncope (fainting)  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Taste alteration (dysgeusia)  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Tremor  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Psychiatric disorders     
Insomnia  1  6/231 (2.60%)  6 7/229 (3.06%)  15
Libido  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Mood alteration  1  9/231 (3.90%)  12 11/229 (4.80%)  16
Renal and urinary disorders     
Hemorrhage GU  1  1/231 (0.43%)  1 2/229 (0.87%)  2
Renal failure  1  3/231 (1.30%)  3 3/229 (1.31%)  3
Renal/Genitourinary - Other  1  1/231 (0.43%)  1 3/229 (1.31%)  3
Urinary frequency/urgency  1  2/231 (0.87%)  3 4/229 (1.75%)  4
Urinary retention (including neurogenic bladder)  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Reproductive system and breast disorders     
Vaginal discharge (non-infectious)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Respiratory, thoracic and mediastinal disorders     
Adult Respiratory Distress Syndrome (ARDS)  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Allergic rhinitis (including sneezing nasal stuffiness postnasal drip)  1  2/231 (0.87%)  2 4/229 (1.75%)  7
Apnea  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Bronchospasm wheezing  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Cough  1  10/231 (4.33%)  12 9/229 (3.93%)  13
Dyspnea (shortness of breath)  1  4/231 (1.73%)  5 4/229 (1.75%)  8
Hemorrhage pulmonary/upper respiratory  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Hypoxia  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Pleural effusion (non-malignant)  1  1/231 (0.43%)  1 1/229 (0.44%)  1
Pneumonitis/pulmonary infiltrates  1  8/231 (3.46%)  8 11/229 (4.80%)  12
Pulmonary/Upper Respiratory - Other  1  3/231 (1.30%)  3 5/229 (2.18%)  5
Skin and subcutaneous tissue disorders     
Dermatology/Skin - Other  1  2/231 (0.87%)  2 0/229 (0.00%)  0
Dry skin  1  6/231 (2.60%)  8 4/229 (1.75%)  5
Hair loss/alopecia (scalp or body)  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)  1  0/231 (0.00%)  0 1/229 (0.44%)  2
Pruritus/itching  1  5/231 (2.16%)  5 3/229 (1.31%)  4
Rash/desquamation  1  57/231 (24.68%)  86 36/229 (15.72%)  56
Sweating (diaphoresis)  1  4/231 (1.73%)  6 4/229 (1.75%)  5
Ulceration  1  1/231 (0.43%)  1 0/229 (0.00%)  0
Urticaria (hives welts wheals)  1  0/231 (0.00%)  0 2/229 (0.87%)  2
Vascular disorders     
Hematoma  1  2/231 (0.87%)  2 0/229 (0.00%)  0
Hemorrhage/Bleeding - Other  1  0/231 (0.00%)  0 1/229 (0.44%)  1
Hot flashes/flushes  1  3/231 (1.30%)  4 0/229 (0.00%)  0
Hypertension  1  2/231 (0.87%)  2 2/229 (0.87%)  2
Hypotension  1  0/231 (0.00%)  0 1/229 (0.44%)  2
Thrombosis/thrombus/embolism  1  5/231 (2.16%)  5 0/229 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 6
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Philip McCarthy, MD
Organization: Roswell Park Cancer Institute
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00114101     History of Changes
Other Study ID Numbers: NCI-2009-00439
NCI-2009-00439 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CDR0000434845
CALGB 100104/ECOG 100104
CALGB-100104 ( Other Identifier: Alliance for Clinical Trials in Oncology )
CALGB-100104 ( Other Identifier: CTEP )
U10CA180821 ( U.S. NIH Grant/Contract )
U10CA031946 ( U.S. NIH Grant/Contract )
First Submitted: June 13, 2005
First Posted: June 14, 2005
Results First Submitted: March 28, 2013
Results First Posted: July 1, 2013
Last Update Posted: August 14, 2018