Trial Outcomes & Findings for A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma (NCT NCT01698801)

Last Updated: 2018-11-08

Results Overview

Number of Complete Responses (CR) plus Very Good Partial Response (VGPR) plus Partial Response (PR) based on the International Myeloma Working Group criteria (IMWG). Any participant who achieved a CR, VGPR, or PR while on study treatment was defined as a responder. CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

26 participants

Primary outcome timeframe

From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.

Results posted on

2018-11-08

Participant Flow

This is an ongoing open-label, single arm, 5 year study consisting of a 28-day screening period followed by a treatment period where participants receive lenalidomide and dexamethasone until their disease progresses or the lenalidomide is discontinued for any reason. This report includes data up to the cut-off of 15 July 2014.

Participant milestones

Participant milestones
Measure	Lenalidomide Plus Dexamethasone Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
Treatment Phase STARTED	26
Treatment Phase COMPLETED	15
Treatment Phase NOT COMPLETED	11
Follow Up Phase STARTED	11
Follow Up Phase COMPLETED	6
Follow Up Phase NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Lenalidomide Plus Dexamethasone Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
Treatment Phase Adverse Event	4
Treatment Phase Protocol Violation	1
Treatment Phase Other	4
Treatment Phase Withdrawal by Subject	1
Treatment Phase Disease progression	1
Follow Up Phase Withdrawal by Subject	1
Follow Up Phase Death	4

Baseline Characteristics

A Phase 2 Study of Lenalidomide to Evaluate the Efficacy in Japanese Patients With Newly Diagnosed Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lenalidomide Plus Dexamethasone n=26 Participants Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.
Age, Continuous	74.2 years STANDARD_DEVIATION 7.01 • n=5 Participants
Age, Customized ≤ 75 Years Old	14 participants n=5 Participants
Age, Customized > 75 Years Old	12 participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Multiple Myeloma Stage before Study Entry Stage I	7 participants n=5 Participants
Multiple Myeloma Stage before Study Entry Stage II	14 participants n=5 Participants
Multiple Myeloma Stage before Study Entry Stage III	5 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 = Fully Active	13 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 1= Restrictive but Ambulatory	7 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 2 = Ambulatory but Unable to Work	6 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 3 = Limited Self-Care	0 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status 4 = Completely Disabled	0 participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose until the data cut-off date of 15 July 2014. Median time on follow-up was 61.6 weeks.

Population: Efficacy Evaluable (EE) Population consists of all participants who met the protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=24 Participants Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.
Overall Response Rate	87.5 percentage of participants

SECONDARY outcome

Timeframe: From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up time was 61.6 weeks.

Population: Efficacy Evaluable (EE) Population consists of all participants who meet protocol requirements (all eligibility criteria) and were evaluated after receiving at least one dose of study drug

Time to response was calculated for the responders as the time from the first dose date to the initial documented response (CR, VGPR or PR). CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. If present at baseline a ≥ 50% reduction in size of soft tissue plasmacytomas is also required.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=24 Participants Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.
Time to Response	1.97 months Interval 0.9 to 13.8

SECONDARY outcome

Timeframe: From the first dose of study drug treatment until the data cut-off date of 15 July2014. Median follow up time was 61.6 weeks.

Duration of response was calculated for the responders as the time from the initial documented response (CR or VGPR or PR) to the first documented progression or death due to any cause, whichever occurred first. Duration of response for participants last known to be alive with no progression after a CR, VGPR, or PR were censored at the date of last adequate response assessment.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=21 Participants Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.
Duration of Response	NA months Interval 10.55 to The median duration of response based on Kaplan-Meier estimate had not been reached by the 15 July 2014 data cut-off date.

SECONDARY outcome

Timeframe: From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow-up for PFS assessments was 61.6 weeks.

PFS was calculated as the time from the first dose date to the first documented progression based on IWG criteria or death due to any cause, whichever occurred first. If progression or death was not documented at the time of data cutoff date, these observations were censored at the last adequate assessment date showing evidence of no progression or death.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=24 Participants Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.
Progression Free Survival (PFS)	NA months The median time to progression free survival based on Kaplan-Meier estimate had not been reached by the 15 July 2014 data cut-off date.

SECONDARY outcome

Timeframe: From the first dose of study drug treatment until the data cut-off date of 15 July 2014. Median follow up is 14.2 months

The time from the start of study treatment to death due to any cause. OS was 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

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=24 Participants Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.
Overall Survival (OS)	17.71 months Interval 17.71 to OS data are interim at data cutoff, with only 3 events in the study treatment phase (median follow-up 14.2 mos)

SECONDARY outcome

Timeframe: From first dose of study drug treatment through to 28 days after the last dose, until the data cut-off date of 15 July 2014; median treatment duration was 60 weeks

Population: Safety population includes all participants who received at least one dose of study drug.

An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death.

Outcome measures

Outcome measures
Measure	Lenalidomide Plus Dexamethasone n=26 Participants Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason. Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.
Number of Participants With Adverse Events Any adverse event	26 participants
Number of Participants With Adverse Events Grade 3-4 adverse event	18 participants
Number of Participants With Adverse Events Grade 3-4 adverse event related to Lenalidomide	15 participants
Number of Participants With Adverse Events Serious TEAE	11 participants
Number of Participants With Adverse Events TEAE leading to discontinuation of lenalidomide	4 participants
Number of Participants With Adverse Events TEAE related to study drug	25 participants
Number of Participants With Adverse Events TEAE related to Lenalidomide	25 participants
Number of Participants With Adverse Events TEAE related to Dexamethasone	20 participants
Number of Participants With Adverse Events Grade 3-4 adverse event related to any study drug	15 participants
Number of Participants With Adverse Events Grade 3-4 adverse event related to Dexamethasone	4 participants
Number of Participants With Adverse Events Serious TEAE related to any study drug	8 participants
Number of Participants With Adverse Events Serious TEAE related to Lenalidomide	8 participants
Number of Participants With Adverse Events Serious TEAE related to Dexamethasone	3 participants
Number of Participants With Adverse Events TEAE leading to discontinuation of either drug	4 participants
Number of Participants With Adverse Events TEAE leading to discontinuation of dexamethasone	2 participants
Number of Participants With Adverse Events Related TEAE discontinuation of either drug	4 participants
Number of Participants With Adverse Events Related TEAE discontinuation of lenalidomide	4 participants
Number of Participants With Adverse Events Related TEAE discontinuation of dexamethasone	0 participants

Adverse Events

Lenalidomide Plus Dexamethasone

Serious events: 11 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lenalidomide Plus Dexamethasone n=26 participants at risk Lenalidomide: 25 mg oral lenalidomide once daily on Days 1 through 21 of each 28-day cycle Dexamethasone: 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle
Cardiac disorders CARDIAC FAILURE ACUTE	3.8% 1/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Cardiac disorders CORONARY ARTERY STENOSIS	3.8% 1/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Infections and infestations PNEUMONIA	3.8% 1/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Infections and infestations URINARY TRACT INFECTION	3.8% 1/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Respiratory, thoracic and mediastinal disorders INTERSTITIAL LUNG DISEASE	3.8% 1/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	3.8% 1/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Blood and lymphatic system disorders THROMBOCYTOPENIA	3.8% 1/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Gastrointestinal disorders LOWER GASTROINTESTINAL HAEMORRHAGE	3.8% 1/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Hepatobiliary disorders HEPATIC FUNCTION ABNORMAL	3.8% 1/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Metabolism and nutrition disorders TUMOUR LYSIS SYNDROME	3.8% 1/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Nervous system disorders PRESYNCOPE	3.8% 1/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Skin and subcutaneous tissue disorders TOXIC SKIN ERUPTION	3.8% 1/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.

Other adverse events

Other adverse events
Measure	Lenalidomide Plus Dexamethasone n=26 participants at risk Lenalidomide: 25 mg oral lenalidomide once daily on Days 1 through 21 of each 28-day cycle Dexamethasone: 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle
Skin and subcutaneous tissue disorders RASH	50.0% 13/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Skin and subcutaneous tissue disorders DRY SKIN	19.2% 5/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Skin and subcutaneous tissue disorders URTICARIA	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Gastrointestinal disorders CONSTIPATION	30.8% 8/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Gastrointestinal disorders STOMATITIS	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Gastrointestinal disorders DENTAL CARIES	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Gastrointestinal disorders NAUSEA	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Gastrointestinal disorders VOMITING	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
General disorders OEDEMA PERIPHERAL	23.1% 6/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
General disorders MALAISE	15.4% 4/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
General disorders FACE OEDEMA	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Infections and infestations NASOPHARYNGITIS	42.3% 11/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Nervous system disorders DYSGEUSIA	15.4% 4/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Blood and lymphatic system disorders ANAEMIA	30.8% 8/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Blood and lymphatic system disorders NEUTROPENIA	26.9% 7/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Blood and lymphatic system disorders THROMBOCYTOPENIA	23.1% 6/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Blood and lymphatic system disorders LEUKOPENIA	23.1% 6/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Blood and lymphatic system disorders LYMPHOPENIA	15.4% 4/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Musculoskeletal and connective tissue disorders BACK PAIN	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Metabolism and nutrition disorders DECREASED APPETITE	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Metabolism and nutrition disorders HYPOPHOSPHATAEMIA	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Investigations ALANINE AMINOTRANSFERASE INCREASED	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Investigations WEIGHT DECREASED	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Psychiatric disorders INSOMNIA	23.1% 6/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Respiratory, thoracic and mediastinal disorders HICCUPS	15.4% 4/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Vascular disorders HYPERTENSION	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Vascular disorders HYPOTENSION	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Hepatobiliary disorders HEPATIC FUNCTION ABNORMAL	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Injury, poisoning and procedural complications HEAD INJURY	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Skin and subcutaneous tissue disorders PRURITUS	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Skin and subcutaneous tissue disorders ERYTHEMA	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Gastrointestinal disorders DIARRHOEA	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Infections and infestations GASTROENTERITIS	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Musculoskeletal and connective tissue disorders MYALGIA	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Nervous system disorders HYPOAESTHESIA	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Metabolism and nutrition disorders DIABETES MELLITUS	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Metabolism and nutrition disorders HYPERURICAEMIA	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Metabolism and nutrition disorders HYPOALBUMINAEMIA	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Metabolism and nutrition disorders HYPONATRAEMIA	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Investigations BLOOD CREATININE INCREASED	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Investigations BLOOD UREA INCREASED	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Injury, poisoning and procedural complications CONTUSION	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Injury, poisoning and procedural complications Fall	7.7% 2/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.
Eye disorders CATARACT	11.5% 3/26 • From first dose of any study drug, through to 28 days after the last dose of the last study drugs received; until the data cut-off date of 14 July 2014. Maximum time on treatment was 89 weeks.

Additional Information

Senior Manager, Clinical Trials 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