Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy (NCT NCT00774345)
NCT ID: NCT00774345
Last Updated: 2021-12-02
Results Overview
Overall Survival (OS) is defined as the time from randomization to death from any cause. OS will be censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
317 participants
Primary outcome timeframe
Up to approximately 11 years
Results posted on
2021-12-02
Participant Flow
317 randomized and 315 treated.
Participant milestones
| Measure |
Lenalidomide
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
Placebo
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
|---|---|---|
|
Pre-treatment
STARTED
|
160
|
157
|
|
Pre-treatment
COMPLETED
|
158
|
157
|
|
Pre-treatment
NOT COMPLETED
|
2
|
0
|
|
Treatment
STARTED
|
158
|
157
|
|
Treatment
Participants Escalated to 5mg
|
129
|
149
|
|
Treatment
Participants Escalated to 10mg
|
68
|
88
|
|
Treatment
COMPLETED
|
0
|
0
|
|
Treatment
NOT COMPLETED
|
158
|
157
|
Reasons for withdrawal
| Measure |
Lenalidomide
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
Placebo
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
|---|---|---|
|
Pre-treatment
Other reasons
|
2
|
0
|
|
Treatment
Adverse Event
|
61
|
15
|
|
Treatment
Progressive Disease without histologic transformation
|
51
|
111
|
|
Treatment
Progressive Disease with histologic transformation
|
4
|
2
|
|
Treatment
Withdrawal by Subject
|
5
|
2
|
|
Treatment
Lost to Follow-up
|
1
|
1
|
|
Treatment
Death
|
4
|
0
|
|
Treatment
Other Reasons
|
32
|
26
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Lenalidomide as Maintenance Therapy for Patients With B-Cell Chronic Lymphocytic Leukemia (CLL) Following Second Line Therapy
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=160 Participants
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
Placebo
n=157 Participants
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
Total
n=317 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 Years
STANDARD_DEVIATION 8.08 • n=93 Participants
|
62.5 Years
STANDARD_DEVIATION 8.85 • n=4 Participants
|
62.7 Years
STANDARD_DEVIATION 8.46 • n=27 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
115 Participants
n=93 Participants
|
113 Participants
n=4 Participants
|
228 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
153 Participants
n=93 Participants
|
156 Participants
n=4 Participants
|
309 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
154 Participants
n=93 Participants
|
150 Participants
n=4 Participants
|
304 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 11 yearsPopulation: All randomized participants
Overall Survival (OS) is defined as the time from randomization to death from any cause. OS will be censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.
Outcome measures
| Measure |
Lenalidomide
n=160 Participants
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
Placebo
n=157 Participants
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
|---|---|---|
|
Overall Survival (OS)
|
95.09 Months
Interval 70.35 to 103.52
|
73.28 Months
Interval 59.98 to 102.98
|
SECONDARY outcome
Timeframe: Up to 6 yearsPopulation: All randomized evaluable participants
Progression Free Survival (PFS2) assessed by investigator is defined as the time from randomization to the second objective disease progression, or death from any cause, whichever occurs first.
Outcome measures
| Measure |
Lenalidomide
n=160 Participants
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
Placebo
n=154 Participants
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
|---|---|---|
|
Progression Free Survival 2 (PFS2)
|
NA Months
Interval 49.5 to
Median and Upper Limit not reached because of too few events to evaluate
|
35.9 Months
Interval 27.4 to
Too few events to estimate the upper limit of the confidence interval
|
SECONDARY outcome
Timeframe: From first dose to 30 days post last dose (up to 9 years)Population: All treated participants
Number of participants with adverse events (AEs) that measure type, frequency and severity of AEs graded by National Cancer Institute Common Terminology Criteria (NCI CTCAE V 3.0) including any grade adverse events (AEs), Grade 3-4 AEs, AEs related to study drug, grade 3-4 AEs related to study drug.
Outcome measures
| Measure |
Lenalidomide
n=158 Participants
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
Placebo
n=157 Participants
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Grade 3-4 AEs related to Study drugs
|
117 Participants
|
41 Participants
|
|
Number of Participants With Adverse Events (AEs)
Adverse Events (AEs)
|
155 Participants
|
149 Participants
|
|
Number of Participants With Adverse Events (AEs)
Grade 3-4 AEs
|
136 Participants
|
73 Participants
|
|
Number of Participants With Adverse Events (AEs)
AEs related to Study drugs
|
143 Participants
|
98 Participants
|
Adverse Events
Lenalidomide
Serious events: 99 serious events
Other events: 152 other events
Deaths: 78 deaths
Placebo
Serious events: 49 serious events
Other events: 140 other events
Deaths: 80 deaths
Serious adverse events
| Measure |
Lenalidomide
n=158 participants at risk
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
Placebo
n=157 participants at risk
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Blood and lymphatic system disorders
Anaemia haemolytic autoimmune
|
1.9%
3/158 • Up to 9 years
|
1.3%
2/157 • Up to 9 years
|
|
Blood and lymphatic system disorders
Autoimmune pancytopenia
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.9%
3/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
1.3%
2/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
31.0%
49/158 • Up to 9 years
|
8.3%
13/157 • Up to 9 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.4%
7/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Cardiac disorders
Angina pectoris
|
0.63%
1/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Cardiac disorders
Atrial fibrillation
|
0.63%
1/158 • Up to 9 years
|
1.3%
2/157 • Up to 9 years
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Cardiac disorders
Cardiac failure congestive
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Cardiac disorders
Myocardial ischaemia
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Cardiac disorders
Sick sinus syndrome
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Eye disorders
Eye movement disorder
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Eye disorders
Optic neuropathy
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.63%
1/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Gastrointestinal disorders
Diarrhoea
|
1.9%
3/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
General disorders
Fatigue
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
General disorders
Impaired healing
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
General disorders
Pyrexia
|
1.9%
3/158 • Up to 9 years
|
1.9%
3/157 • Up to 9 years
|
|
General disorders
Soft tissue inflammation
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Hepatobiliary disorders
Biliary colic
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.3%
2/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Appendicitis
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Arthritis bacterial
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Bacteraemia
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Bacterial sepsis
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Bone tuberculosis
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Bronchitis
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Bronchopneumonia
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Cellulitis
|
1.3%
2/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Disseminated tuberculosis
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Empyema
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Epstein-Barr viraemia
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Gastroenteritis
|
0.63%
1/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Gastroenteritis viral
|
1.3%
2/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
H1N1 influenza
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Hepatitis B
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Herpes zoster ophthalmic
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Influenza
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Lobar pneumonia
|
1.3%
2/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Lower respiratory tract infection
|
1.9%
3/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Lymph node abscess
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Neutropenic sepsis
|
1.3%
2/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Orchitis
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Otitis media
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Pharyngitis
|
1.3%
2/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.63%
1/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Pneumonia
|
4.4%
7/158 • Up to 9 years
|
5.1%
8/157 • Up to 9 years
|
|
Infections and infestations
Pneumonia escherichia
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Pneumonia mycoplasmal
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Pneumonia primary atypical
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Pyelonephritis
|
1.3%
2/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Respiratory tract infection
|
1.9%
3/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Respiratory tract infection viral
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Salmonella sepsis
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Sepsis
|
3.2%
5/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Septic shock
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Sinusitis
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Urinary tract infection
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Infections and infestations
Viral labyrinthitis
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Infections and infestations
Viral pericarditis
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/158 • Up to 9 years
|
1.3%
2/157 • Up to 9 years
|
|
Investigations
Blood bicarbonate decreased
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Investigations
International normalised ratio increased
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
5.7%
9/158 • Up to 9 years
|
5.1%
8/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.63%
1/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage III
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.63%
1/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/158 • Up to 9 years
|
1.3%
2/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small intestine carcinoma
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
5.1%
8/158 • Up to 9 years
|
2.5%
4/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Nervous system disorders
Cerebral infarction
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Nervous system disorders
Cranial nerve disorder
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Nervous system disorders
Demyelination
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Nervous system disorders
Diplegia
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Nervous system disorders
Migraine
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Nervous system disorders
Syncope
|
0.63%
1/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Nervous system disorders
Transient ischaemic attack
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Nervous system disorders
Visual field defect
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Renal and urinary disorders
Calculus urinary
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/158 • Up to 9 years
|
1.3%
2/157 • Up to 9 years
|
|
Renal and urinary disorders
Renal failure
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.3%
2/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
2/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.5%
4/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Skin and subcutaneous tissue disorders
Dermatitis herpetiformis
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
Vascular disorders
Circulatory collapse
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
|
Vascular disorders
Hypotension
|
0.63%
1/158 • Up to 9 years
|
0.00%
0/157 • Up to 9 years
|
Other adverse events
| Measure |
Lenalidomide
n=158 participants at risk
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
Placebo
n=157 participants at risk
2.5mg QD PO with escalation after 28 days to 5mg QD PO x 28 days, only if the 2.5mg dose was tolerated. Participants could be escalated to 10mg QD PO x 28 days, but only after 5 continuous cycles at 5mg and only if 5mg was well tolerated and if those participants had not achieved MRD-negative CR
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.7%
9/158 • Up to 9 years
|
4.5%
7/157 • Up to 9 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.6%
12/158 • Up to 9 years
|
1.3%
2/157 • Up to 9 years
|
|
Blood and lymphatic system disorders
Neutropenia
|
67.1%
106/158 • Up to 9 years
|
28.0%
44/157 • Up to 9 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
27.8%
44/158 • Up to 9 years
|
12.1%
19/157 • Up to 9 years
|
|
Gastrointestinal disorders
Abdominal pain
|
11.4%
18/158 • Up to 9 years
|
5.7%
9/157 • Up to 9 years
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.7%
9/158 • Up to 9 years
|
2.5%
4/157 • Up to 9 years
|
|
Gastrointestinal disorders
Constipation
|
17.1%
27/158 • Up to 9 years
|
5.1%
8/157 • Up to 9 years
|
|
Gastrointestinal disorders
Diarrhoea
|
41.1%
65/158 • Up to 9 years
|
16.6%
26/157 • Up to 9 years
|
|
Gastrointestinal disorders
Dyspepsia
|
7.6%
12/158 • Up to 9 years
|
5.1%
8/157 • Up to 9 years
|
|
Gastrointestinal disorders
Nausea
|
16.5%
26/158 • Up to 9 years
|
17.2%
27/157 • Up to 9 years
|
|
Gastrointestinal disorders
Vomiting
|
7.6%
12/158 • Up to 9 years
|
8.3%
13/157 • Up to 9 years
|
|
General disorders
Asthenia
|
6.3%
10/158 • Up to 9 years
|
1.3%
2/157 • Up to 9 years
|
|
General disorders
Chills
|
6.3%
10/158 • Up to 9 years
|
0.64%
1/157 • Up to 9 years
|
|
General disorders
Fatigue
|
35.4%
56/158 • Up to 9 years
|
34.4%
54/157 • Up to 9 years
|
|
General disorders
Influenza like illness
|
7.0%
11/158 • Up to 9 years
|
1.3%
2/157 • Up to 9 years
|
|
General disorders
Oedema peripheral
|
10.1%
16/158 • Up to 9 years
|
7.6%
12/157 • Up to 9 years
|
|
General disorders
Pyrexia
|
17.7%
28/158 • Up to 9 years
|
10.8%
17/157 • Up to 9 years
|
|
Infections and infestations
Bronchitis
|
13.9%
22/158 • Up to 9 years
|
7.6%
12/157 • Up to 9 years
|
|
Infections and infestations
Herpes zoster
|
5.7%
9/158 • Up to 9 years
|
5.7%
9/157 • Up to 9 years
|
|
Infections and infestations
Influenza
|
8.9%
14/158 • Up to 9 years
|
1.9%
3/157 • Up to 9 years
|
|
Infections and infestations
Lower respiratory tract infection
|
7.6%
12/158 • Up to 9 years
|
4.5%
7/157 • Up to 9 years
|
|
Infections and infestations
Nasopharyngitis
|
10.1%
16/158 • Up to 9 years
|
11.5%
18/157 • Up to 9 years
|
|
Infections and infestations
Oral herpes
|
6.3%
10/158 • Up to 9 years
|
4.5%
7/157 • Up to 9 years
|
|
Infections and infestations
Pharyngitis
|
6.3%
10/158 • Up to 9 years
|
4.5%
7/157 • Up to 9 years
|
|
Infections and infestations
Pneumonia
|
6.3%
10/158 • Up to 9 years
|
1.3%
2/157 • Up to 9 years
|
|
Infections and infestations
Respiratory tract infection
|
8.9%
14/158 • Up to 9 years
|
6.4%
10/157 • Up to 9 years
|
|
Infections and infestations
Sinusitis
|
10.1%
16/158 • Up to 9 years
|
3.2%
5/157 • Up to 9 years
|
|
Infections and infestations
Upper respiratory tract infection
|
19.6%
31/158 • Up to 9 years
|
17.8%
28/157 • Up to 9 years
|
|
Infections and infestations
Viral infection
|
5.1%
8/158 • Up to 9 years
|
3.2%
5/157 • Up to 9 years
|
|
Investigations
Blood bilirubin increased
|
5.1%
8/158 • Up to 9 years
|
2.5%
4/157 • Up to 9 years
|
|
Investigations
Weight decreased
|
13.9%
22/158 • Up to 9 years
|
8.9%
14/157 • Up to 9 years
|
|
Investigations
Weight increased
|
3.2%
5/158 • Up to 9 years
|
5.7%
9/157 • Up to 9 years
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.5%
15/158 • Up to 9 years
|
5.7%
9/157 • Up to 9 years
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
6.3%
10/158 • Up to 9 years
|
1.9%
3/157 • Up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.6%
23/158 • Up to 9 years
|
6.4%
10/157 • Up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.4%
18/158 • Up to 9 years
|
12.7%
20/157 • Up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
13.9%
22/158 • Up to 9 years
|
6.4%
10/157 • Up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.0%
11/158 • Up to 9 years
|
4.5%
7/157 • Up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.5%
4/158 • Up to 9 years
|
5.1%
8/157 • Up to 9 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.2%
13/158 • Up to 9 years
|
3.8%
6/157 • Up to 9 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
7.6%
12/158 • Up to 9 years
|
5.7%
9/157 • Up to 9 years
|
|
Nervous system disorders
Dizziness
|
10.1%
16/158 • Up to 9 years
|
5.7%
9/157 • Up to 9 years
|
|
Nervous system disorders
Headache
|
10.8%
17/158 • Up to 9 years
|
8.9%
14/157 • Up to 9 years
|
|
Psychiatric disorders
Insomnia
|
6.3%
10/158 • Up to 9 years
|
6.4%
10/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.1%
46/158 • Up to 9 years
|
20.4%
32/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.1%
16/158 • Up to 9 years
|
7.0%
11/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.5%
15/158 • Up to 9 years
|
10.2%
16/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.5%
4/158 • Up to 9 years
|
6.4%
10/157 • Up to 9 years
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.3%
10/158 • Up to 9 years
|
2.5%
4/157 • Up to 9 years
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
6.3%
10/158 • Up to 9 years
|
1.9%
3/157 • Up to 9 years
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.1%
8/158 • Up to 9 years
|
1.3%
2/157 • Up to 9 years
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
7.0%
11/158 • Up to 9 years
|
3.2%
5/157 • Up to 9 years
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
19.0%
30/158 • Up to 9 years
|
19.7%
31/157 • Up to 9 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
12.7%
20/158 • Up to 9 years
|
5.7%
9/157 • Up to 9 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
26.6%
42/158 • Up to 9 years
|
8.3%
13/157 • Up to 9 years
|
|
Vascular disorders
Hypertension
|
5.1%
8/158 • Up to 9 years
|
7.6%
12/157 • Up to 9 years
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email:
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER