Trial Outcomes & Findings for Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma (NCT NCT00179673)
NCT ID: NCT00179673
Last Updated: 2025-05-13
Results Overview
Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities. Cru: Criteria for CR above but with 1 or more of the following: • A residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD) • Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). PR: ≥ 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD.
COMPLETED
PHASE2
43 participants
From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 months
2025-05-13
Participant Flow
Participant milestones
| Measure |
Lenalidomide
Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
|
|---|---|
|
Overall Study
STARTED
|
43
|
|
Overall Study
Received Study Drug
|
43
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
43
|
Reasons for withdrawal
| Measure |
Lenalidomide
Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Lack of Efficacy
|
15
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Death
|
4
|
|
Overall Study
Other Observations and options
|
14
|
Baseline Characteristics
Lenalidomide (Revlimid®, CC-5013) in Subjects With Relapsed or Refractory Indolent Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=43 Participants
Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
|
|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 10.95 • n=5 Participants
|
|
Age, Customized
<65 years
|
24 participants
n=5 Participants
|
|
Age, Customized
65 - 75
|
10 participants
n=5 Participants
|
|
Age, Customized
>75 years
|
9 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
37 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other = Unspecified
|
1 participants
n=5 Participants
|
|
NHL Duration
|
5.6 years
STANDARD_DEVIATION 4.38 • n=5 Participants
|
|
Non-Hodgkin's Lymphoma (NHL) Histology
Follicular lymphoma grade 1 or 2
|
22 participants
n=5 Participants
|
|
Non-Hodgkin's Lymphoma (NHL) Histology
Small Lymphocytic lymphoma
|
18 participants
n=5 Participants
|
|
Non-Hodgkin's Lymphoma (NHL) Histology
Nodal marginal-zone B-cell lymphoma
|
2 participants
n=5 Participants
|
|
Non-Hodgkin's Lymphoma (NHL) Histology
Extranodal marginal-zone B-cell type (MALT)
|
1 participants
n=5 Participants
|
|
Non-Hodgkin's Lymphoma (NHL)-Stage
Stage I
|
1 participants
n=5 Participants
|
|
Non-Hodgkin's Lymphoma (NHL)-Stage
Stage II
|
11 participants
n=5 Participants
|
|
Non-Hodgkin's Lymphoma (NHL)-Stage
Stage III
|
6 participants
n=5 Participants
|
|
Non-Hodgkin's Lymphoma (NHL)-Stage
Stage IV
|
25 participants
n=5 Participants
|
|
International Prognostic Index (IPI)]
Low (0 to 1)
|
14 participants
n=5 Participants
|
|
International Prognostic Index (IPI)]
Low/Intermediate (2)
|
15 participants
n=5 Participants
|
|
International Prognostic Index (IPI)]
High/Intermediate (3)
|
6 participants
n=5 Participants
|
|
International Prognostic Index (IPI)]
High (4 to 5)
|
8 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0 = fully active, no restrictions;
|
27 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1 = restricted but ambulatory and capable of light
|
12 participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
2 = ambulatory and capable of self care but unable
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 monthsPopulation: Intent-to-treat (ITT) population, which included all enrolled patients who received at least 1 dose of study drug. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders.
Response was defined as participants with a complete response (CR), unconfirmed complete response (Cru) or partial response (PR), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. CR: Complete disappearance of all detectable clinical and radiographic evidence of disease, disappearance of any disease-related symptoms, and normalization of biochemical abnormalities. Cru: Criteria for CR above but with 1 or more of the following: • A residual lymph node mass \> 1.5 cm in greatest transverse diameter that has regressed by more than 75% in the sum of the products of diameters (SPD) • Indeterminate bone marrow (increased number or size of aggregates without cytologic or architectural atypia). PR: ≥ 50% decrease in SPD of the 6 largest dominant nodes or nodal masses. No increase in the size of other nodes, liver, or spleen. Splenic and hepatic nodules must regress by at least 50% in the SPD.
Outcome measures
| Measure |
Lenalidomide
n=43 Participants
Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
|
|---|---|
|
Percentage of Participants With Response
|
23.3 percentage of participants
Interval 11.8 to 38.6
|
SECONDARY outcome
Timeframe: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 monthsPopulation: Intent-to-treat (ITT) population. Patients who dropped out without having a response assessment or who had a response after they had received other anti-cancer treatments were considered non-responders
Tumor control was defined as participants with a complete response, unconfirmed complete response, partial response or stable disease (SD), assessed using the International Workshop Lymphoma Response Criteria (IWLRC) and based on best responses as determined by the investigator. SD was defined as a response less than a PR (see above) but not Progressive Disease (PD). PD was defined as • ≥ 50 % increase from nadir in the SPD of any previously identified abnormal node for partial responders or non-responders. • Appearance of any new lesion during or at the end of therapy.
Outcome measures
| Measure |
Lenalidomide
n=43 Participants
Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
|
|---|---|
|
Percentage of Participants With Tumor Control
|
60.5 percentage of participants
Interval 44.4 to 75.0
|
SECONDARY outcome
Timeframe: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 monthsPopulation: Includes participants with a response to treatment
The duration of response was calculated as the first response assessment demonstrating evidence of at least a partial response to the first documentation of progressive disease (as determined by computed tomography scan) or death due to NHL, whichever occurred first. For participants without documentation of progression, the duration of response was censored at the last date of tumor assessment indicating no progression. Median was based on the Kaplan-Meier estimate.
Outcome measures
| Measure |
Lenalidomide
n=10 Participants
Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
|
|---|---|
|
The Duration of Response
|
NA months
Interval 15.5 to
The median was not reached due to the low number of events.
|
SECONDARY outcome
Timeframe: From enrollment through study completion. Median duration on study was 4.4 months with a maximum of 32 monthsPopulation: Intent to treat population
Progression-free survival was defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause, whichever came first. Participants who withdrew for any reason or received another NHL therapy including stem cell transplantation without documented progressive disease were censored on the date of their last adequate response assessment indicating no progression (or last adequate assessment prior to receiving other NHL therapy). Participants who were still active without progressive disease at the time of the data cut-off date were censored on the date of their last adequate response assessment.
Outcome measures
| Measure |
Lenalidomide
n=43 Participants
Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
|
|---|---|
|
Progression Free Survival (PFS)
|
4.4 months
Interval 2.5 to 10.4
|
SECONDARY outcome
Timeframe: From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months.Population: Safety Population, which includes all participants who received at least one dose of study drug.
The Investigator determined the relationship between the administration of study drug and the occurrence of an AE as suspected if the temporal relationship of the adverse event to study drug administration made a causal relationship possible, and other drugs, therapeutic interventions, or underlying conditions did not provide a sufficient explanation for the observed event. The Investigator graded the severity of AEs according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria and the following scale: • Grade 1 = Mild • Grade 2 = Moderate • Grade 3 = Severe • Grade 4 = Life threatening • Grade 5 = Death A Serious AE is defined as any AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or constitutes an important medical event.
Outcome measures
| Measure |
Lenalidomide
n=43 Participants
Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
At least one Adverse Event (AE)
|
42 participants
|
|
Number of Participants With Adverse Events (AEs)
≥ 1 AE related to study drug
|
37 participants
|
|
Number of Participants With Adverse Events (AEs)
Grade (GR) 3-5 AE
|
27 participants
|
|
Number of Participants With Adverse Events (AEs)
Grade 3-5 AE related to study drug
|
24 participants
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse event (SAE)
|
18 participants
|
|
Number of Participants With Adverse Events (AEs)
SAE related to study drug
|
10 participants
|
|
Number of Participants With Adverse Events (AEs)
AE leading to discontinuation of study drug
|
9 participants
|
|
Number of Participants With Adverse Events (AEs)
Related AE leading to study drug discontinuation
|
5 participants
|
|
Number of Participants With Adverse Events (AEs)
AE leading to dose reduction or interruption
|
27 participants
|
Adverse Events
Lenalidomide
Serious adverse events
| Measure |
Lenalidomide
n=43 participants at risk
Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia Not Otherwise Specified (NOS)
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Blood and lymphatic system disorders
Lymph Node Pain
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Gastrointestinal disorders
Abdominal Pain NOS
|
4.7%
2/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
General disorders
Pyrexia
|
4.7%
2/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Infections and infestations
Sepsis NOS
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Nervous system disorders
Transient Ischaemic Attack
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
General disorders
Asthenia
|
4.7%
2/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
General disorders
Fatigue
|
4.7%
2/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
General disorders
Chest Discomfort
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
General disorders
Oedema Peripheral
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Gastrointestinal disorders
Gastrointestinal Obstruction NOS
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Gastrointestinal disorders
Intestinal Fistula
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Gastrointestinal disorders
Small Intestinal Obstruction NOS
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Infections and infestations
Pneumonia NOS
|
4.7%
2/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Infections and infestations
Clostridial Infestion NOS
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Infections and infestations
Infection NOS
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Nervous system disorders
Somnolence
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Airways Disease
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea NOS
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Cardiac disorders
Cardio-Respiratory Arrest
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma NOS
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.3%
1/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
Other adverse events
| Measure |
Lenalidomide
n=43 participants at risk
Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
|
|---|---|
|
General disorders
Fatigue
|
46.5%
20/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
General disorders
Oedema Peripheral
|
9.3%
4/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
General disorders
Pain NOS
|
9.3%
4/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
General disorders
Pyrexia
|
9.3%
4/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Gastrointestinal disorders
Constipation
|
30.2%
13/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Gastrointestinal disorders
Diarrhoea NOS
|
30.2%
13/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Gastrointestinal disorders
Nausea
|
18.6%
8/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Gastrointestinal disorders
Abdominal Pain NOS
|
11.6%
5/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
44.2%
19/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
34.9%
15/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Blood and lymphatic system disorders
Leukopenia NOS
|
23.3%
10/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Blood and lymphatic system disorders
Anaemia NOS
|
16.3%
7/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Investigations
Haemoglobin Decreased
|
18.6%
8/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Investigations
Neutrophil Count Decreased
|
18.6%
8/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Investigations
Alanine Aminotransferase Increased
|
11.6%
5/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Investigations
Blood Alkaline Phosphatase NOS Increased
|
9.3%
4/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Investigations
White Blood Cell Count Decreased
|
9.3%
4/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Investigations
Aspartate Aminotransferase Increased
|
7.0%
3/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Investigations
Platelet Count Decreased
|
7.0%
3/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Skin and subcutaneous tissue disorders
Rash NOS
|
23.3%
10/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
11.6%
5/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Skin and subcutaneous tissue disorders
Night Sweats
|
7.0%
3/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.3%
7/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Cramp
|
11.6%
5/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.3%
7/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
11.6%
5/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Nervous system disorders
Headache
|
9.3%
4/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Nervous system disorders
Hypoaesthesia
|
7.0%
3/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia NOS
|
11.6%
5/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.0%
3/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Psychiatric disorders
Insomnia
|
14.0%
6/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour Flare
|
9.3%
4/43 • From the start of study drug through 30 days after the last dose of study drug. Maximum time on study drug was 13.8 months
|
Additional Information
Senior Manager, Clinical Trials Disclosure
Celgene Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator shall have the right to publish and/or present study data provided that the investigator shall (i) furnish the sponsor a copy of any proposed publication or presentation generally thirty (60) days in advance of the submission, (ii) delete any confidential information of the sponsor, and (iii) delay submission for generally up to ninety (90) days to permit the preparation and filing of intellectual property applications or until sponsor gives its consent in a timely manner.
- Publication restrictions are in place
Restriction type: OTHER