Trial Outcomes & Findings for Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant (NCT NCT00114101)
NCT ID: NCT00114101
Last Updated: 2025-11-24
Results Overview
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
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
460 participants
Primary outcome timeframe
Duration of study (up to 10years)
Results posted on
2025-11-24
Participant Flow
From December 2004 and July 2009, a total of 568 participants were recruited to this study.
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)
Participant milestones
| Measure |
Lenalidomide Maintenance
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.
|
Placebo Maintenance
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 Study
STARTED
|
231
|
229
|
|
Overall Study
COMPLETED
|
231
|
229
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Transplant
Baseline characteristics by cohort
| Measure |
Lenalidomide Maintenance
n=231 Participants
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.
|
Placebo Maintenance
n=229 Participants
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
n=460 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59 years
n=45 Participants
|
58 years
n=12929 Participants
|
59 years
n=6349 Participants
|
|
Sex: Female, Male
Female
|
110 Participants
n=45 Participants
|
100 Participants
n=12929 Participants
|
210 Participants
n=6349 Participants
|
|
Sex: Female, Male
Male
|
121 Participants
n=45 Participants
|
129 Participants
n=12929 Participants
|
250 Participants
n=6349 Participants
|
|
Region of Enrollment
United States
|
231 participants
n=45 Participants
|
229 participants
n=12929 Participants
|
460 participants
n=6349 Participants
|
|
Beta 2 microglobulin at registration
> 2.5 mg/liter
|
50 participants
n=45 Participants
|
55 participants
n=12929 Participants
|
105 participants
n=6349 Participants
|
|
Beta 2 microglobulin at registration
<= 2.5 mg/liter
|
170 participants
n=45 Participants
|
163 participants
n=12929 Participants
|
333 participants
n=6349 Participants
|
|
Beta 2 microglobulin at registration
Missing data
|
11 participants
n=45 Participants
|
11 participants
n=12929 Participants
|
22 participants
n=6349 Participants
|
|
Prior use of thalidomide during induction
Yes
|
102 participants
n=45 Participants
|
103 participants
n=12929 Participants
|
205 participants
n=6349 Participants
|
|
Prior use of thalidomide during induction
No
|
129 participants
n=45 Participants
|
126 participants
n=12929 Participants
|
255 participants
n=6349 Participants
|
|
Prior use of lenalidomide during induction therapy
Yes
|
79 participants
n=45 Participants
|
81 participants
n=12929 Participants
|
160 participants
n=6349 Participants
|
|
Prior use of lenalidomide during induction therapy
No
|
152 participants
n=45 Participants
|
148 participants
n=12929 Participants
|
300 participants
n=6349 Participants
|
PRIMARY outcome
Timeframe: Duration of study (up to 10years)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
Outcome measures
| Measure |
Lenalidomide Maintenance
n=231 Participants
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.
|
Placebo Maintenance
n=229 Participants
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)
|
|---|---|---|
|
Time to Progression
|
39 months
Interval 36.0 to
The upper limit was not calculable because an insufficient number of participants reached the event at the final time point for assessment
|
21 months
Interval 18.0 to 28.0
|
SECONDARY outcome
Timeframe: Day 100Response 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
Outcome measures
| Measure |
Lenalidomide Maintenance
n=231 Participants
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.
|
Placebo Maintenance
n=229 Participants
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)
|
|---|---|---|
|
Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
Progressive disease
|
0 participants
|
3 participants
|
|
Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
Complete response
|
67 participants
|
79 participants
|
|
Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
Partial response
|
115 participants
|
109 participants
|
|
Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
Marginal response
|
11 participants
|
5 participants
|
|
Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
Stable disease
|
38 participants
|
32 participants
|
|
Response to Autologous Hematopoietic Stem-cell Transplant (HSCT) at Day 100
Unknown
|
0 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Duration of study (up to 10 years)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.
Outcome measures
| Measure |
Lenalidomide Maintenance
n=231 Participants
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.
|
Placebo Maintenance
n=229 Participants
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 Survival
|
NA months
The median overall survival has not been reached.
|
NA months
The median overall survival has not been reached.
|
POST_HOC outcome
Timeframe: Duration of study (up to 10 years)Patients who develop progression (defined in primary outcome measure), died or develop a new primary malignancy (cancer) will summarized in this outcome.
Outcome measures
| Measure |
Lenalidomide Maintenance
n=231 Participants
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.
|
Placebo Maintenance
n=229 Participants
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)
|
|---|---|---|
|
Number of Participants With Progression, Death or Diagnosis of Second Primary Malignancy
|
92 participants
|
133 participants
|
Adverse Events
Lenalidomide Maintenance
Serious events: 52 serious events
Other events: 195 other events
Deaths: 0 deaths
Placebo Maintenance
Serious events: 33 serious events
Other events: 166 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenalidomide Maintenance
n=231 participants at risk
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.
|
Placebo Maintenance
n=229 participants at risk
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)
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.6%
6/231 • Number of events 6
|
0.87%
2/229 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.5%
8/231 • Number of events 8
|
2.2%
5/229 • Number of events 5
|
|
Blood and lymphatic system disorders
Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Cardiac disorders
Conduction abnormality/atrioventricular heart block
|
0.43%
1/231 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
0.43%
1/231 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
|
Endocrine disorders
Thyroid function high (hyperthyroidism thyrotoxicosis)
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Eye disorders
Cataract
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Eye disorders
Ocular/Visual - Other
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Gastrointestinal disorders
Constipation
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Gastrointestinal disorders
Diarrhea
|
8.2%
19/231 • Number of events 22
|
3.9%
9/229 • Number of events 9
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.43%
1/231 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.2%
5/231 • Number of events 5
|
1.7%
4/229 • Number of events 4
|
|
Gastrointestinal disorders
Obstruction GI
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
Gastrointestinal disorders
Ulcer, GI
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
0.43%
1/231 • Number of events 1
|
1.3%
3/229 • Number of events 3
|
|
General disorders
Constitutional Symptoms - Other
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
General disorders
Death not associated with CTCAE term
|
0.87%
2/231 • Number of events 2
|
0.87%
2/229 • Number of events 2
|
|
General disorders
Edema: limb
|
0.43%
1/231 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
1.3%
3/231 • Number of events 3
|
0.87%
2/229 • Number of events 2
|
|
General disorders
Fever
|
1.3%
3/231 • Number of events 3
|
1.7%
4/229 • Number of events 4
|
|
General disorders
Pain - Other
|
0.43%
1/231 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
|
General disorders
Rigors/chills
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Infections and infestations
Infection
|
6.9%
16/231 • Number of events 18
|
3.1%
7/229 • Number of events 7
|
|
Infections and infestations
Infection - Other
|
1.7%
4/231 • Number of events 4
|
0.44%
1/229 • Number of events 1
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
6.1%
14/231 • Number of events 14
|
3.9%
9/229 • Number of events 13
|
|
Infections and infestations
Infection with unknown ANC
|
0.00%
0/231
|
3.1%
7/229 • Number of events 8
|
|
Infections and infestations
Infection without neutropenia
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Injury, poisoning and procedural complications
Fracture
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access-related)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
1.3%
3/231 • Number of events 3
|
0.44%
1/229 • Number of events 1
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
1.7%
4/231 • Number of events 4
|
0.44%
1/229 • Number of events 1
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
4.3%
10/231 • Number of events 12
|
1.7%
4/229 • Number of events 5
|
|
Investigations
Cardiac troponin I (cTnI)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Investigations
Creatinine
|
0.43%
1/231 • Number of events 2
|
1.3%
3/229 • Number of events 3
|
|
Investigations
Fibrinogen
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
0.87%
2/231 • Number of events 2
|
0.44%
1/229 • Number of events 1
|
|
Investigations
Leukocytes (total WBC)
|
4.3%
10/231 • Number of events 11
|
0.87%
2/229 • Number of events 2
|
|
Investigations
Lipase
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Investigations
Lymphopenia
|
2.2%
5/231 • Number of events 5
|
1.3%
3/229 • Number of events 3
|
|
Investigations
Metabolic/Laboratory - Other
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
17.3%
40/231 • Number of events 47
|
6.1%
14/229 • Number of events 16
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Investigations
Platelets
|
16.9%
39/231 • Number of events 45
|
7.0%
16/229 • Number of events 21
|
|
Investigations
Weight gain
|
0.43%
1/231 • Number of events 1
|
1.3%
3/229 • Number of events 3
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
0.87%
2/231 • Number of events 2
|
1.3%
3/229 • Number of events 3
|
|
Metabolism and nutrition disorders
Anorexia
|
0.87%
2/231 • Number of events 2
|
0.44%
1/229 • Number of events 1
|
|
Metabolism and nutrition disorders
Calcium serum-high (hypercalcemia)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Metabolism and nutrition disorders
Calcium serum-low (hypocalcemia)
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
0.43%
1/231 • Number of events 1
|
1.7%
4/229 • Number of events 4
|
|
Metabolism and nutrition disorders
Glucose serum-high (hyperglycemia)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose serum-low (hypoglycemia)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Metabolism and nutrition disorders
Magnesium serum-low (hypomagnesemia)
|
0.43%
1/231 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
|
Metabolism and nutrition disorders
Phosphate serum-low (hypophosphatemia)
|
1.3%
3/231 • Number of events 4
|
1.3%
3/229 • Number of events 3
|
|
Metabolism and nutrition disorders
Potassium serum-high (hyperkalemia)
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
Metabolism and nutrition disorders
Potassium serum-low (hypokalemia)
|
1.3%
3/231 • Number of events 3
|
1.3%
3/229 • Number of events 3
|
|
Metabolism and nutrition disorders
Sodium serum-low (hyponatremia)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis)
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Musculoskeletal and connective tissue disorders
Pain
|
2.6%
6/231 • Number of events 8
|
3.9%
9/229 • Number of events 12
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.43%
1/231 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
|
Nervous system disorders
Dizziness
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Nervous system disorders
Memory impairment
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Nervous system disorders
Mental status
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Nervous system disorders
Neurology - Other
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Nervous system disorders
Neuropathy: motor
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Nervous system disorders
Neuropathy: sensory
|
0.43%
1/231 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
|
Nervous system disorders
Seizure
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Nervous system disorders
Syncope (fainting)
|
0.87%
2/231 • Number of events 2
|
0.87%
2/229 • Number of events 2
|
|
Psychiatric disorders
Confusion
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
Psychiatric disorders
Mood alteration
|
1.7%
4/231 • Number of events 4
|
0.44%
1/229 • Number of events 1
|
|
Renal and urinary disorders
Renal failure
|
0.43%
1/231 • Number of events 2
|
0.87%
2/229 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
3/231 • Number of events 3
|
0.87%
2/229 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
1.3%
3/231 • Number of events 3
|
2.2%
5/229 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.3%
3/231 • Number of events 3
|
1.3%
3/229 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
1.3%
3/231 • Number of events 4
|
1.7%
4/229 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
2.6%
6/231 • Number of events 6
|
1.7%
4/229 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Vascular disorders
Hypertension
|
0.00%
0/231
|
1.3%
3/229 • Number of events 3
|
|
Vascular disorders
Hypotension
|
0.43%
1/231 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.87%
2/231 • Number of events 2
|
0.44%
1/229 • Number of events 1
|
Other adverse events
| Measure |
Lenalidomide Maintenance
n=231 participants at risk
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.
|
Placebo Maintenance
n=229 participants at risk
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)
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other
|
0.87%
2/231 • Number of events 4
|
0.44%
1/229 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.9%
9/231 • Number of events 10
|
1.3%
3/229 • Number of events 4
|
|
Blood and lymphatic system disorders
Hemoglobin
|
11.3%
26/231 • Number of events 45
|
3.9%
9/229 • Number of events 22
|
|
Blood and lymphatic system disorders
Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
Cardiac disorders
Cardiac General - Other
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Cardiac disorders
Conduction abnormality/atrioventricular heart block
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Cardiac disorders
Edema
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Cardiac disorders
Palpitations
|
0.87%
2/231 • Number of events 2
|
0.44%
1/229 • Number of events 1
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
1.3%
3/231 • Number of events 3
|
0.44%
1/229 • Number of events 1
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/231
|
0.44%
1/229 • Number of events 2
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Endocrine disorders
Thyroid function high (hyperthyroidism thyrotoxicosis)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Endocrine disorders
Thyroid function, low (hypothyroidism)
|
0.43%
1/231 • Number of events 2
|
0.87%
2/229 • Number of events 2
|
|
Eye disorders
Cataract
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Eye disorders
Ocular/Visual - Other
|
0.00%
0/231
|
1.7%
4/229 • Number of events 4
|
|
Eye disorders
Vision-blurred vision
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 2
|
|
Eye disorders
Watery eye (epiphora tearing)
|
0.00%
0/231
|
0.87%
2/229 • Number of events 3
|
|
Gastrointestinal disorders
Colitis
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
3.9%
9/231 • Number of events 10
|
3.1%
7/229 • Number of events 12
|
|
Gastrointestinal disorders
Dental: periodontal disease
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
38.5%
89/231 • Number of events 227
|
22.7%
52/229 • Number of events 90
|
|
Gastrointestinal disorders
Distension/bloating, abdominal
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
0.43%
1/231 • Number of events 2
|
1.3%
3/229 • Number of events 4
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Esophagitis
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
1.3%
3/231 • Number of events 3
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
1.3%
3/231 • Number of events 3
|
0.00%
0/229
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Melena/GI bleeding
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
0.87%
2/231 • Number of events 2
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
5.6%
13/231 • Number of events 15
|
4.4%
10/229 • Number of events 15
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies if specified in the protocol.
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Gastrointestinal disorders
Vomiting
|
3.9%
9/231 • Number of events 10
|
2.6%
6/229 • Number of events 9
|
|
General disorders
Constitutional Symptoms - Other
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
General disorders
Edema: limb
|
1.7%
4/231 • Number of events 5
|
1.3%
3/229 • Number of events 3
|
|
General disorders
Edema:head and neck
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
15.6%
36/231 • Number of events 55
|
12.7%
29/229 • Number of events 54
|
|
General disorders
Fever
|
3.9%
9/231 • Number of events 10
|
0.87%
2/229 • Number of events 2
|
|
General disorders
Flu-like syndrome
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
General disorders
Pain - Other
|
0.43%
1/231 • Number of events 1
|
3.5%
8/229 • Number of events 14
|
|
General disorders
Rigors/chills
|
1.7%
4/231 • Number of events 6
|
0.44%
1/229 • Number of events 3
|
|
General disorders
Syndromes - Other
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Hepatobiliary disorders
Cholecystitis
|
0.87%
2/231 • Number of events 2
|
0.00%
0/229
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Immune system disorders
Allergy/Immunology - Other
|
0.87%
2/231 • Number of events 2
|
0.00%
0/229
|
|
Infections and infestations
Infection
|
6.9%
16/231 • Number of events 17
|
4.8%
11/229 • Number of events 14
|
|
Infections and infestations
Infection - Other
|
2.6%
6/231 • Number of events 6
|
1.3%
3/229 • Number of events 3
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
4.8%
11/231 • Number of events 14
|
6.1%
14/229 • Number of events 18
|
|
Infections and infestations
Infection with unknown ANC
|
6.5%
15/231 • Number of events 18
|
3.9%
9/229 • Number of events 11
|
|
Infections and infestations
Infection without neutropenia
|
0.87%
2/231 • Number of events 3
|
0.44%
1/229 • Number of events 1
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Infections and infestations
Viral hepatitis
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Injury, poisoning and procedural complications
Bruising (in absence of Grade 3 or 4 thrombocytopenia)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Injury, poisoning and procedural complications
Burn
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Injury, poisoning and procedural complications
Fracture
|
0.43%
1/231 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
|
Injury, poisoning and procedural complications
Intra-operative injury
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
4.8%
11/231 • Number of events 13
|
0.87%
2/229 • Number of events 3
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
3.0%
7/231 • Number of events 8
|
1.3%
3/229 • Number of events 5
|
|
Investigations
Alkaline phosphatase
|
2.2%
5/231 • Number of events 5
|
1.7%
4/229 • Number of events 4
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
10.4%
24/231 • Number of events 66
|
7.9%
18/229 • Number of events 36
|
|
Investigations
CPK (creatine phosphokinase)
|
0.43%
1/231 • Number of events 3
|
0.00%
0/229
|
|
Investigations
Creatinine
|
0.87%
2/231 • Number of events 2
|
2.2%
5/229 • Number of events 9
|
|
Investigations
GGT (gamma-Glutamyl transpeptidase)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
1.3%
3/231 • Number of events 7
|
0.00%
0/229
|
|
Investigations
Leukocytes (total WBC)
|
12.6%
29/231 • Number of events 72
|
6.1%
14/229 • Number of events 33
|
|
Investigations
Lymphopenia
|
7.4%
17/231 • Number of events 31
|
3.9%
9/229 • Number of events 23
|
|
Investigations
Metabolic/Laboratory - Other
|
0.87%
2/231 • Number of events 3
|
1.3%
3/229 • Number of events 4
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
66.2%
153/231 • Number of events 593
|
32.8%
75/229 • Number of events 181
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
Investigations
Platelets
|
55.8%
129/231 • Number of events 445
|
34.1%
78/229 • Number of events 200
|
|
Investigations
Weight gain
|
5.6%
13/231 • Number of events 21
|
9.2%
21/229 • Number of events 33
|
|
Investigations
Weight loss
|
0.43%
1/231 • Number of events 2
|
0.44%
1/229 • Number of events 1
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
0.43%
1/231 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
|
Metabolism and nutrition disorders
Anorexia
|
2.2%
5/231 • Number of events 5
|
2.6%
6/229 • Number of events 7
|
|
Metabolism and nutrition disorders
Calcium serum-high (hypercalcemia)
|
0.00%
0/231
|
0.87%
2/229 • Number of events 3
|
|
Metabolism and nutrition disorders
Calcium serum-low (hypocalcemia)
|
2.6%
6/231 • Number of events 6
|
2.2%
5/229 • Number of events 6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Metabolism and nutrition disorders
Glucose serum-high (hyperglycemia)
|
3.5%
8/231 • Number of events 12
|
3.1%
7/229 • Number of events 18
|
|
Metabolism and nutrition disorders
Glucose serum-low (hypoglycemia)
|
1.3%
3/231 • Number of events 3
|
0.44%
1/229 • Number of events 2
|
|
Metabolism and nutrition disorders
Phosphate serum-low (hypophosphatemia)
|
0.87%
2/231 • Number of events 2
|
1.3%
3/229 • Number of events 4
|
|
Metabolism and nutrition disorders
Potassium serum-high (hyperkalemia)
|
1.3%
3/231 • Number of events 3
|
0.44%
1/229 • Number of events 1
|
|
Metabolism and nutrition disorders
Potassium serum-low (hypokalemia)
|
3.9%
9/231 • Number of events 11
|
1.7%
4/229 • Number of events 7
|
|
Metabolism and nutrition disorders
Sodium serum-low (hyponatremia)
|
0.87%
2/231 • Number of events 2
|
0.44%
1/229 • Number of events 1
|
|
Metabolism and nutrition disorders
Triglyceride serum-high (hypertriglyceridemia)
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Metabolism and nutrition disorders
Uric acid serum-high (hyperuricemia)
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Joint-function
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Musculoskeletal and connective tissue disorders
Lumbar spine-range of motion
|
0.00%
0/231
|
0.44%
1/229 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
0.43%
1/231 • Number of events 1
|
0.87%
2/229 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
0.00%
0/231
|
1.7%
4/229 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Myositis (inflammation/damage of muscle)
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain
|
15.2%
35/231 • Number of events 84
|
21.8%
50/229 • Number of events 154
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment
|
2.2%
5/231 • Number of events 5
|
0.44%
1/229 • Number of events 1
|
|
Nervous system disorders
Ataxia (incoordination)
|
0.87%
2/231 • Number of events 3
|
0.00%
0/229
|
|
Nervous system disorders
Dizziness
|
1.7%
4/231 • Number of events 8
|
3.5%
8/229 • Number of events 9
|
|
Nervous system disorders
Headache
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Nervous system disorders
Hemorrhage CNS
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Nervous system disorders
Memory impairment
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Nervous system disorders
Neurology - Other
|
0.43%
1/231 • Number of events 1
|
1.7%
4/229 • Number of events 4
|
|
Nervous system disorders
Neuropathy: cranial
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Nervous system disorders
Neuropathy: motor
|
2.6%
6/231 • Number of events 10
|
1.7%
4/229 • Number of events 6
|
|
Nervous system disorders
Neuropathy: sensory
|
10.4%
24/231 • Number of events 40
|
10.5%
24/229 • Number of events 49
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Nervous system disorders
Syncope (fainting)
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Nervous system disorders
Tremor
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Psychiatric disorders
Insomnia
|
2.6%
6/231 • Number of events 6
|
3.1%
7/229 • Number of events 15
|
|
Psychiatric disorders
Libido
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Psychiatric disorders
Mood alteration
|
3.9%
9/231 • Number of events 12
|
4.8%
11/229 • Number of events 16
|
|
Renal and urinary disorders
Hemorrhage GU
|
0.43%
1/231 • Number of events 1
|
0.87%
2/229 • Number of events 2
|
|
Renal and urinary disorders
Renal failure
|
1.3%
3/231 • Number of events 3
|
1.3%
3/229 • Number of events 3
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
0.43%
1/231 • Number of events 1
|
1.3%
3/229 • Number of events 3
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.87%
2/231 • Number of events 3
|
1.7%
4/229 • Number of events 4
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Reproductive system and breast disorders
Vaginal discharge (non-infectious)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing nasal stuffiness postnasal drip)
|
0.87%
2/231 • Number of events 2
|
1.7%
4/229 • Number of events 7
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm wheezing
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
10/231 • Number of events 12
|
3.9%
9/229 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
1.7%
4/231 • Number of events 5
|
1.7%
4/229 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary/upper respiratory
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.43%
1/231 • Number of events 1
|
0.44%
1/229 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
3.5%
8/231 • Number of events 8
|
4.8%
11/229 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
1.3%
3/231 • Number of events 3
|
2.2%
5/229 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
0.87%
2/231 • Number of events 2
|
0.00%
0/229
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.6%
6/231 • Number of events 8
|
1.7%
4/229 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Skin and subcutaneous tissue disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
0.00%
0/231
|
0.44%
1/229 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
2.2%
5/231 • Number of events 5
|
1.3%
3/229 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
24.7%
57/231 • Number of events 86
|
15.7%
36/229 • Number of events 56
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
1.7%
4/231 • Number of events 6
|
1.7%
4/229 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.43%
1/231 • Number of events 1
|
0.00%
0/229
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives welts wheals)
|
0.00%
0/231
|
0.87%
2/229 • Number of events 2
|
|
Vascular disorders
Hematoma
|
0.87%
2/231 • Number of events 2
|
0.00%
0/229
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
0.00%
0/231
|
0.44%
1/229 • Number of events 1
|
|
Vascular disorders
Hot flashes/flushes
|
1.3%
3/231 • Number of events 4
|
0.00%
0/229
|
|
Vascular disorders
Hypertension
|
0.87%
2/231 • Number of events 2
|
0.87%
2/229 • Number of events 2
|
|
Vascular disorders
Hypotension
|
0.00%
0/231
|
0.44%
1/229 • Number of events 2
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.2%
5/231 • Number of events 5
|
0.00%
0/229
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60