Trial Outcomes & Findings for A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma (NCT NCT00478777)
NCT ID: NCT00478777
Last Updated: 2011-11-03
Results Overview
Time to disease progression (TTP) was based on the European Group for Blood and Marrow Transplantation (EBMT) myeloma response determination criteria developed by Bladé (Bladé, 1998). TTP is a Kaplan Meier estimate of the time from randomization to the first documentation of progressive disease. Progressive disease based on increasing monoclonal paraprotein levels require a confirmatory value one week apart. Disease progression can also be based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
150 participants
Primary outcome timeframe
up to 827 days
Results posted on
2011-11-03
Participant Flow
A total of 150 participants in 37 sites in Germany were enrolled when lenalidomide became commercially available in Germany. Study completion (end of study) was the time point when participants discontinued study drug and could switch to commercial lenalidomide.
Participant milestones
| Measure |
Lenalidomide Plus Dexamethasone
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
|
|---|---|
|
Overall Study
STARTED
|
150
|
|
Overall Study
Safety and Full Analysis Set (FAS)
|
144
|
|
Overall Study
COMPLETED
|
73
|
|
Overall Study
NOT COMPLETED
|
77
|
Reasons for withdrawal
| Measure |
Lenalidomide Plus Dexamethasone
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
|
|---|---|
|
Overall Study
Adverse Event
|
29
|
|
Overall Study
Lack of Efficacy
|
23
|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Death
|
3
|
|
Overall Study
Protocol Violation
|
3
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Intolerance of therapy
|
1
|
|
Overall Study
Lack of compliance
|
1
|
|
Overall Study
Lymphocytes infusion
|
1
|
|
Overall Study
End of therapy
|
2
|
|
Overall Study
Not treated with lenalidomide
|
6
|
Baseline Characteristics
A Multicenter, Single-Arm, Open-Label Expanded Access Program for Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Lenalidomide Plus Dexamethasone
n=144 Participants
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
|
|---|---|
|
Age Continuous
|
64.7 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
142 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
144 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 827 daysPopulation: Full analysis dataset
Time to disease progression (TTP) was based on the European Group for Blood and Marrow Transplantation (EBMT) myeloma response determination criteria developed by Bladé (Bladé, 1998). TTP is a Kaplan Meier estimate of the time from randomization to the first documentation of progressive disease. Progressive disease based on increasing monoclonal paraprotein levels require a confirmatory value one week apart. Disease progression can also be based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia.
Outcome measures
| Measure |
Lenalidomide Plus Dexamethasone
n=144 Participants
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
|
|---|---|
|
Kaplan Meier Estimate for Time to Disease Progression
|
214.0 days
Interval 146.0 to 281.0
|
SECONDARY outcome
Timeframe: Up to 827 daysPopulation: Full analysis set
Best overall response was calculated as the best assessment from all cycles (including treatment discontinuation visit) and follow-up. The response rate was summarized as complete response (CR), partial response (PR), stable disease (SD), progression (PD), response not evaluable, and derived categories (PR+CR) and (PR+CR+SD). CR is negative immunofixation on both serum and urine maintained for 6 weeks straight. PR is a 50% decrease in serum paraprotein maintained for 6 weeks straight. SD is serum paraprotein values within 25% of baseline.
Outcome measures
| Measure |
Lenalidomide Plus Dexamethasone
n=144 Participants
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
|
|---|---|
|
Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria
Complete response (CR)
|
6 participants
|
|
Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria
Partial response (PR)
|
97 participants
|
|
Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria
Stable disease (SD)
|
30 participants
|
|
Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria
Progressive disease (PD)
|
3 participants
|
|
Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria
Not evaluable (NE)
|
8 participants
|
|
Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria
CR + PR
|
103 participants
|
|
Participant's Best Overall Response Based on the European Group for Blood and Marrow Transplantation (EBMT) Myeloma Response Criteria
CR + PR + SD
|
133 participants
|
SECONDARY outcome
Timeframe: up to 8 monthsPopulation: Safety population
Counts of study participants who had treatment-emergent adverse events (TEAEs) defined as any reported AE that started on or after the first day of study drug dosing. A participant with multiple occurrences of an adverse event within a category is counted only once in that category. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) was used by investigators to assess TEAEs. Severity scale ranges from 0 (none) to 5 (death). Grade 3=severe AE; Grade 4=life threatening or disabling AE; Grade 5=death.
Outcome measures
| Measure |
Lenalidomide Plus Dexamethasone
n=144 Participants
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
|
|---|---|
|
Participants With Treatment-emergent Adverse Experiences (TEAEs)
>=1 TEAE
|
139 participants
|
|
Participants With Treatment-emergent Adverse Experiences (TEAEs)
>=1 TEAE related to study drug
|
119 participants
|
|
Participants With Treatment-emergent Adverse Experiences (TEAEs)
>=1 NCI CTCAE grade 3 or 4 TEAE
|
105 participants
|
|
Participants With Treatment-emergent Adverse Experiences (TEAEs)
>=1 NCI CTCAE grade 3 or 4 TEAE related to drug
|
83 participants
|
|
Participants With Treatment-emergent Adverse Experiences (TEAEs)
>=1 serious AE (SAE)
|
79 participants
|
|
Participants With Treatment-emergent Adverse Experiences (TEAEs)
>=1 study drug related SAE
|
48 participants
|
|
Participants With Treatment-emergent Adverse Experiences (TEAEs)
Discontinued due to TEAE
|
32 participants
|
|
Participants With Treatment-emergent Adverse Experiences (TEAEs)
Discontinued due to TEAE related to study drug
|
21 participants
|
|
Participants With Treatment-emergent Adverse Experiences (TEAEs)
TEAE leading to dose reduction
|
35 participants
|
|
Participants With Treatment-emergent Adverse Experiences (TEAEs)
TEAE leading to dose interruption
|
64 participants
|
|
Participants With Treatment-emergent Adverse Experiences (TEAEs)
Deaths
|
79 participants
|
SECONDARY outcome
Timeframe: up to 827 daysPopulation: Values for the free light chain concentrations were determined to be invalid.
Time to partial response is the time from randomization to a 50% decrease in serum paraprotein maintained for six weeks straight. This was determined by free light chain concentrations which were taken every two weeks during the treatment phase of the trial.
Outcome measures
Outcome data not reported
Adverse Events
Lenalidomide Plus Dexamethasone
Serious events: 79 serious events
Other events: 129 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenalidomide Plus Dexamethasone
n=144 participants at risk
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
|
|---|---|
|
General disorders
Pyrexia
|
9.7%
14/144 • Up to 8 months
|
|
General disorders
General physical health deterioration
|
4.2%
6/144 • Up to 8 months
|
|
General disorders
Asthenia
|
1.4%
2/144 • Up to 8 months
|
|
General disorders
Multi-organ failure
|
1.4%
2/144 • Up to 8 months
|
|
General disorders
Chills
|
0.69%
1/144 • Up to 8 months
|
|
General disorders
Fatigue
|
0.69%
1/144 • Up to 8 months
|
|
General disorders
Gait disturbance
|
0.69%
1/144 • Up to 8 months
|
|
General disorders
Orthostatic intolerance
|
0.69%
1/144 • Up to 8 months
|
|
General disorders
Pain
|
0.69%
1/144 • Up to 8 months
|
|
Infections and infestations
Pneumonia
|
5.6%
8/144 • Up to 8 months
|
|
Infections and infestations
Sepsis
|
4.2%
6/144 • Up to 8 months
|
|
Infections and infestations
Upper respiratory tract infection
|
1.4%
2/144 • Up to 8 months
|
|
Infections and infestations
Bronchitis
|
0.69%
1/144 • Up to 8 months
|
|
Infections and infestations
Febrile infection
|
0.69%
1/144 • Up to 8 months
|
|
Infections and infestations
Gastrointestinal infection
|
0.69%
1/144 • Up to 8 months
|
|
Infections and infestations
Herpes zoster
|
0.69%
1/144 • Up to 8 months
|
|
Infections and infestations
Infection
|
0.69%
1/144 • Up to 8 months
|
|
Infections and infestations
Lung infection
|
0.69%
1/144 • Up to 8 months
|
|
Infections and infestations
Respiratory tract infection
|
0.69%
1/144 • Up to 8 months
|
|
Infections and infestations
Tooth infection
|
0.69%
1/144 • Up to 8 months
|
|
Infections and infestations
Urinary tract infection
|
0.69%
1/144 • Up to 8 months
|
|
Infections and infestations
Urosepsis
|
0.69%
1/144 • Up to 8 months
|
|
Gastrointestinal disorders
Diarrhoea
|
3.5%
5/144 • Up to 8 months
|
|
Gastrointestinal disorders
Nausea
|
2.1%
3/144 • Up to 8 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
1.4%
2/144 • Up to 8 months
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
2/144 • Up to 8 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.69%
1/144 • Up to 8 months
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.69%
1/144 • Up to 8 months
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.69%
1/144 • Up to 8 months
|
|
Gastrointestinal disorders
Duodenitis
|
0.69%
1/144 • Up to 8 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.69%
1/144 • Up to 8 months
|
|
Gastrointestinal disorders
Large intestinal perforation
|
0.69%
1/144 • Up to 8 months
|
|
Gastrointestinal disorders
Subileus
|
0.69%
1/144 • Up to 8 months
|
|
Gastrointestinal disorders
Tooth disorder
|
0.69%
1/144 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.1%
3/144 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
1.4%
2/144 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
2/144 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.69%
1/144 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.69%
1/144 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.69%
1/144 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.69%
1/144 • Up to 8 months
|
|
Nervous system disorders
Syncope
|
2.1%
3/144 • Up to 8 months
|
|
Nervous system disorders
Dizziness
|
1.4%
2/144 • Up to 8 months
|
|
Nervous system disorders
Grand mal convulsion
|
0.69%
1/144 • Up to 8 months
|
|
Nervous system disorders
Headache
|
0.69%
1/144 • Up to 8 months
|
|
Nervous system disorders
Neurological symptom
|
0.69%
1/144 • Up to 8 months
|
|
Nervous system disorders
Neuromyopathy
|
0.69%
1/144 • Up to 8 months
|
|
Nervous system disorders
Syncope vasovagal
|
0.69%
1/144 • Up to 8 months
|
|
Nervous system disorders
Tremor
|
0.69%
1/144 • Up to 8 months
|
|
Blood and lymphatic system disorders
Anaemia
|
3.5%
5/144 • Up to 8 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.8%
4/144 • Up to 8 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.1%
3/144 • Up to 8 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.4%
2/144 • Up to 8 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.4%
2/144 • Up to 8 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.69%
1/144 • Up to 8 months
|
|
Cardiac disorders
Cardiac failure
|
2.1%
3/144 • Up to 8 months
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
2/144 • Up to 8 months
|
|
Cardiac disorders
Tachyarrhythmia
|
1.4%
2/144 • Up to 8 months
|
|
Cardiac disorders
Angina pectoris
|
0.69%
1/144 • Up to 8 months
|
|
Cardiac disorders
Arrhythmia
|
0.69%
1/144 • Up to 8 months
|
|
Cardiac disorders
Atrial flutter
|
0.69%
1/144 • Up to 8 months
|
|
Cardiac disorders
Bundle branch block right
|
0.69%
1/144 • Up to 8 months
|
|
Cardiac disorders
Extrasystoles
|
0.69%
1/144 • Up to 8 months
|
|
Cardiac disorders
Myocardial infarction
|
0.69%
1/144 • Up to 8 months
|
|
Cardiac disorders
Pericardial effusion
|
0.69%
1/144 • Up to 8 months
|
|
Cardiac disorders
Ventricular fibrillation
|
0.69%
1/144 • Up to 8 months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.69%
1/144 • Up to 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
4.2%
6/144 • Up to 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.69%
1/144 • Up to 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
|
0.69%
1/144 • Up to 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia plasmacytic
|
0.69%
1/144 • Up to 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.69%
1/144 • Up to 8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.69%
1/144 • Up to 8 months
|
|
Renal and urinary disorders
Renal failure
|
2.8%
4/144 • Up to 8 months
|
|
Renal and urinary disorders
Renal failure acute
|
2.1%
3/144 • Up to 8 months
|
|
Renal and urinary disorders
Renal impairment
|
0.69%
1/144 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.8%
4/144 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.1%
3/144 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
2/144 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.69%
1/144 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.69%
1/144 • Up to 8 months
|
|
Vascular disorders
Thrombosis
|
2.1%
3/144 • Up to 8 months
|
|
Vascular disorders
Hypotension
|
1.4%
2/144 • Up to 8 months
|
|
Vascular disorders
Circulatory collapse
|
0.69%
1/144 • Up to 8 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.69%
1/144 • Up to 8 months
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.69%
1/144 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.4%
2/144 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
2/144 • Up to 8 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.69%
1/144 • Up to 8 months
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.69%
1/144 • Up to 8 months
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.69%
1/144 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.69%
1/144 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.69%
1/144 • Up to 8 months
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
2.1%
3/144 • Up to 8 months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.69%
1/144 • Up to 8 months
|
|
Psychiatric disorders
Confusional state
|
1.4%
2/144 • Up to 8 months
|
|
Psychiatric disorders
Depression
|
0.69%
1/144 • Up to 8 months
|
|
Psychiatric disorders
Disorientation
|
0.69%
1/144 • Up to 8 months
|
|
Psychiatric disorders
Mental disorder due to a general medical condition
|
0.69%
1/144 • Up to 8 months
|
|
Psychiatric disorders
Psychotic disorder
|
0.69%
1/144 • Up to 8 months
|
|
Ear and labyrinth disorders
Vertigo
|
2.1%
3/144 • Up to 8 months
|
|
Investigations
Haemoglobin decreased
|
0.69%
1/144 • Up to 8 months
|
|
Investigations
Platelet count decreased
|
0.69%
1/144 • Up to 8 months
|
|
Investigations
Protein total increased
|
0.69%
1/144 • Up to 8 months
|
|
Investigations
White blood cell count increased
|
0.69%
1/144 • Up to 8 months
|
|
Congenital, familial and genetic disorders
Epidermolysis bullosa
|
0.69%
1/144 • Up to 8 months
|
|
Congenital, familial and genetic disorders
Factor VIII deficiency
|
0.69%
1/144 • Up to 8 months
|
|
Eye disorders
Vision blurred
|
0.69%
1/144 • Up to 8 months
|
|
Immune system disorders
Acute graft versus host disease in intestine
|
0.69%
1/144 • Up to 8 months
|
|
Immune system disorders
Graft versus host disease
|
0.69%
1/144 • Up to 8 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.69%
1/144 • Up to 8 months
|
Other adverse events
| Measure |
Lenalidomide Plus Dexamethasone
n=144 participants at risk
Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
24.3%
35/144 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.0%
13/144 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
12/144 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.6%
11/144 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
9/144 • Up to 8 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.6%
8/144 • Up to 8 months
|
|
General disorders
Fatigue
|
22.9%
33/144 • Up to 8 months
|
|
General disorders
Oedema peripheral
|
13.2%
19/144 • Up to 8 months
|
|
General disorders
Pyrexia
|
12.5%
18/144 • Up to 8 months
|
|
Nervous system disorders
Dizziness
|
11.8%
17/144 • Up to 8 months
|
|
Nervous system disorders
Tremor
|
10.4%
15/144 • Up to 8 months
|
|
Nervous system disorders
Polyneuropathy
|
9.7%
14/144 • Up to 8 months
|
|
Nervous system disorders
Paraesthesia
|
5.6%
8/144 • Up to 8 months
|
|
Gastrointestinal disorders
Diarrhoea
|
15.3%
22/144 • Up to 8 months
|
|
Gastrointestinal disorders
Constipation
|
13.9%
20/144 • Up to 8 months
|
|
Gastrointestinal disorders
Nausea
|
6.2%
9/144 • Up to 8 months
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.4%
28/144 • Up to 8 months
|
|
Blood and lymphatic system disorders
Thromboyctopenia
|
17.4%
25/144 • Up to 8 months
|
|
Blood and lymphatic system disorders
Anaemia
|
10.4%
15/144 • Up to 8 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
9.7%
14/144 • Up to 8 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.3%
12/144 • Up to 8 months
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
12/144 • Up to 8 months
|
|
Infections and infestations
Urinary tract infection
|
6.2%
9/144 • Up to 8 months
|
|
Investigations
Haemoglobin decreased
|
9.0%
13/144 • Up to 8 months
|
|
Investigations
C-reactive protein increased
|
8.3%
12/144 • Up to 8 months
|
|
Psychiatric disorders
Insomnia
|
10.4%
15/144 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.2%
9/144 • Up to 8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
5.6%
8/144 • Up to 8 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.2%
9/144 • Up to 8 months
|
Additional Information
Associate Director, Clinical Trials Disclosure
Celgene Corporation
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee * Multicenter publication must include input from investigators and Celgene, agreement to be established before publication. It has priority over subset (single center) publication, for duration of 1 year after study completion. * Individual investigators have publication right after multicenter publication is complete (or 1 year after study completion), whichever is first. In this case, Celgene has the right to comment and right to ask delay of publication for 90 days.
- Publication restrictions are in place
Restriction type: OTHER