Trial Outcomes & Findings for A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma (NCT NCT00928486)
NCT ID: NCT00928486
Last Updated: 2019-11-20
Results Overview
A TEAE was defined as any AE that started on or after the first dose of study drug, and within End of Study (EOS) (28 days after the last dose of study drug received). A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; or constitutes an important medical event. The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild grade (Grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
25 participants
Primary outcome timeframe
Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
Results posted on
2019-11-20
Participant Flow
Participant milestones
| Measure |
Lenalidomide and Dexamethasone
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
Efficacy Evaluable (EE)
|
24
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Lenalidomide and Dexamethasone
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Disease Progression
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
A Safety Confirmation Study on Lenalidomide With Dexamethasone In Japanese Patients With Previously Treated Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Lenalidomide and Dexamethasone
n=25 Participants
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
|
|---|---|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 9.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeksPopulation: Safety population included all 25 participants who received at least one dose of study drug.
A TEAE was defined as any AE that started on or after the first dose of study drug, and within End of Study (EOS) (28 days after the last dose of study drug received). A serious AE (SAE) = any AE which results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability; is a congenital anomaly/birth defect; or constitutes an important medical event. The intensity of AEs were graded 1 to 5 according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. For all other AEs not described in the CTCAE criteria, the intensity was assessed by the investigator as mild grade (Grade 1), moderate (grade 2), severe (grade 3), life-threatening (grade 4) or death (grade 5)
Outcome measures
| Measure |
Lenalidomide and Dexamethasone
n=25 Participants
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
|
|---|---|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
Related AE leading to dose reduction/interruption
|
16 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
Any Adverse Event (AE)
|
25 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
Drug-Related AE
|
25 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
Grade 3-4 Adverse Event
|
22 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
Drug-Related Grade 3-4 AE
|
21 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
Serious Adverse Event (SAE)
|
12 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
Drug-Related SAE
|
9 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
AE Leading to Study Drug Discontinuation
|
4 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
Related AE Leading to Len/Dex Discontinuation
|
2 participants
|
|
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAE)
AE leading to dose reduction or interruption
|
17 participants
|
SECONDARY outcome
Timeframe: From the time of the first dose of study drug to study completion; median duration on study was 42.1 weeksPopulation: Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria
Overall myeloma response rate was determined by the investigator using the Myeloma Response Determination Criteria adapted from Bladé criteria. A responder is any patient who showed at least a partial response. Overall myeloma response rate is defined as the percentage of participants who achieved a Complete Response (CR), plus a Remission Response (RR), plus a Partial Response (PR). A CR is the disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks. RR is a 75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. PR is a 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion.
Outcome measures
| Measure |
Lenalidomide and Dexamethasone
n=24 Participants
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
|
|---|---|
|
Myeloma Response Rate
|
62.5 percentage of participants
|
SECONDARY outcome
Timeframe: From the time of the first dose of study drug to study completion; the median duration on study was 42.1 weeksPopulation: Efficacy Population = all participants who received at least one dose of study drug, who were evaluated for efficacy at least once after study drug dose administration and who met inclusion criteria who were responders
Duration of response was defined as the time from the first observation of a response (CR, RR or PR) to the first documented disease progression or relapse. For participants who did not progress during the study, duration of response was censored at the last adequate response assessment showing evidence of no disease progression. Disease progression is defined as an increase in M-protein serum monoclonal paraprotein and/or urine paraprotein or evidence of bone marrow plasmacytosis and plasma cells, an appearance of new or existing soft tissue plasmacytomas, an appearance of new or existing lytic bone lesions and/or hypercalcemia \>11.5mg/dL
Outcome measures
| Measure |
Lenalidomide and Dexamethasone
n=15 Participants
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
|
|---|---|
|
Kaplan-Meier Estimates of Duration of Response (DoR)
|
NA weeks
The median duration of response estimate was not reached at the last time data was censored at the last assessment date with no evidence of progression.
|
Adverse Events
Lenalidomide and Dexamethasone
Serious events: 12 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenalidomide and Dexamethasone
n=25 participants at risk
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
|
|---|---|
|
General disorders
Death
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
General disorders
Pyrexia
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Waldenstrom's macroglobulinaemia
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Cardiac disorders
Myocardial infarction
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Ear and labyrinth disorders
Vertigo positional
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Eye disorders
Cataract
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Immune system disorders
Amyloidosis
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Infections and infestations
Herpes zoster
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Nervous system disorders
Diplegia 1 ( 4.0)
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
4.0%
1/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
Other adverse events
| Measure |
Lenalidomide and Dexamethasone
n=25 participants at risk
Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance \<60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
80.0%
20/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Blood and lymphatic system disorders
Lymphopenia
|
64.0%
16/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Blood and lymphatic system disorders
Leukopenia
|
60.0%
15/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
52.0%
13/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
28.0%
7/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Gastrointestinal disorders
Constipation
|
52.0%
13/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
12.0%
3/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Gastrointestinal disorders
Dental caries
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Infections and infestations
Nasopharyngitis
|
48.0%
12/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Infections and infestations
Bronchitis
|
16.0%
4/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Infections and infestations
Influenza
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Infections and infestations
Pharyngitis
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Infections and infestations
Pneumonia
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Infections and infestations
Sinusitis
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Investigations
Fibrin D dimer increased
|
24.0%
6/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Investigations
Blood glucose increased
|
20.0%
5/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Investigations
Fibrin degradation products increased
|
20.0%
5/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Investigations
Alanine aminotransferase increased
|
12.0%
3/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
12.0%
3/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Investigations
Weight decreased
|
12.0%
3/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Investigations
C-reactive protein increased
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Nervous system disorders
Dysgeusia
|
24.0%
6/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Nervous system disorders
Tremor
|
16.0%
4/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Nervous system disorders
Dizziness
|
12.0%
3/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Nervous system disorders
Headache
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Nervous system disorders
Hypogeusia
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
General disorders
Malaise
|
28.0%
7/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
General disorders
Face oedema
|
12.0%
3/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
General disorders
Pyrexia
|
12.0%
3/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
General disorders
Fatigue
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
General disorders
Oedema
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
General disorders
Oedema peripheral
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
32.0%
8/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.0%
4/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
16.0%
4/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
16.0%
4/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.0%
3/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Psychiatric disorders
Insomnia
|
24.0%
6/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Psychiatric disorders
Anxiety
|
12.0%
3/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
24.0%
6/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
12.0%
3/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Cardiac disorders
Palpitations
|
12.0%
3/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Cardiac disorders
Arrhythmia
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Eye disorders
Conjunctivitis
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
|
Vascular disorders
Hot flush
|
8.0%
2/25 • Day 1 of study drug through 28 days after the last dose of study drug; maximum treatment duration was 60.3 weeks
|
Additional Information
Anne McClain, Senior Manager, Clinical Trial Disclosure
Celgene Corporation
Phone: 1-888-260-1599
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Disclosure agreements varied; the Investigators shall not disclose any material/information disclosed by the Sponsor (Celgene KK) with the clinical trial or information obtained by conducting the clinical trial to third parties without Sponsor's prior written approval.
- Publication restrictions are in place
Restriction type: OTHER