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Trial record 36 of 494 for:    LENALIDOMIDE AND every 28 days

A Multicentre, Single-arm, Open-label Safety Study of Lenalidomide Plus Dexamethasone in Previously Treated Subjects With Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT00420849
Recruitment Status : Completed
First Posted : January 11, 2007
Results First Posted : March 14, 2012
Last Update Posted : May 21, 2012
Sponsor:
Information provided by (Responsible Party):
Celgene ( Celgene Corporation )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Multiple Myeloma
Interventions Drug: Lenalidomide
Drug: Dexamethasone
Enrollment 587
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description 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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Period Title: Overall Study
Started 587
Completed 256 [1]
Not Completed 331
Reason Not Completed
Lack of Efficacy             154
Adverse Event             107
Withdrawal by Subject             28
Death             18
Not specified             14
Transplant             8
Protocol Violation             1
Lost to Follow-up             1
[1]
Participants completed the study upon commercial availability of lenalidomide
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description 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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Overall Number of Baseline Participants 587
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 587 participants
64.5  (9.74)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 587 participants
<=18 years 0
>18 and <=65 years 314
>65 years 273
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 587 participants
Female
241
  41.1%
Male
346
  58.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participant
Number Analyzed 587 participants
White 548
Other 17
Asian / Pacific Islander 10
Black 9
Hispanic 3
1.Primary Outcome
Title Overall Incidence of Treatment-emergent Adverse Events (TEAEs), by Severity, Seriousness, and Relationship to Treatment
Hide Description

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.

Time Frame up to 123 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Overall Number of Participants Analyzed 587
Measure Type: Number
Unit of Measure: participants
At least one treatment-emergent AE (TEAE) 586
At least one TEAE related to study drug 519
At least one TEAE with severity grade of 3 or 4 471
At least one serious AE (SAE) 340
2.Secondary Outcome
Title Participants With Adverse Events of Special Interest: Peripheral Neuropathy
Hide Description Number of participants with at least one peripheral neuropathy treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for peripheral neuropathy in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.
Time Frame up to 124 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Overall Number of Participants Analyzed 587
Measure Type: Number
Unit of Measure: participants
At least one TEAE of peripheral neuropathy 84
Neuropathy peripheral 46
Peripheral sensory neuropathy 33
Neuralgia 5
Peripheral motor neuropathy 2
Polyneuropathy 2
Sensory disturbance 1
3.Secondary Outcome
Title Time to First Peripheral Neuropathy Treatment-Emergent Adverse Event (TEAE)
Hide Description Time between first dose and when a TEAE for peripheral neuropathy was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.
Time Frame up to 124 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Overall Number of Participants Analyzed 587
Mean (Standard Deviation)
Unit of Measure: weeks
25.6  (21.53)
4.Secondary Outcome
Title Participants With Adverse Events of Special Interest: Venous Thromboembolic Events
Hide Description Number of participants with at least one venous thromboembolic treatment-emergent adverse event (TEAE), and number of participants reporting AEs coded to preferred terms that comprise the search terms for venous thromboembolic events in MedDRA version 9.0 are listed. A participant with multiple occurrences of a TEAE was counted only once for that category.
Time Frame up to 124 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Overall Number of Participants Analyzed 587
Measure Type: Number
Unit of Measure: participants
At least one venous thromboembolic event 60
Deep vein thrombosis 38
Pulmonary embolism 23
Thrombophlebitis 7
Venous thrombosis limb 1
5.Secondary Outcome
Title Time to First Venous Thromboembolic Treatment-Emergent Adverse Event (TEAE)
Hide Description Time between first dose and when a TEAE for venous thromboembolic event was reported. The mean is the univariate mean without adjusting for censoring. The treatment duration was used for censored participants.
Time Frame up to 124 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
Overall Number of Participants Analyzed 587
Mean (Standard Deviation)
Unit of Measure: weeks
26.5  (21.51)
6.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Physical Functioning Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. EORTC QLQ-C30 includes functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting), and other (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4-point scale (1 ‘Not at All’ to 4 ‘Very Much’); 2 questions used 7-point scale (1 ‘Very Poor’ to 7 ‘Excellent’). Scores are averaged, and transformed to 0-100 scale; higher score=better level of physical functioning.
Time Frame Baseline (Day 0), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants who completed the questionnaire at baseline and week 24.
Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 153 123 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.6  (16.19) -2.9  (16.54) -1.8  (15.10)
7.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Role Functioning Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score=better level of role functioning.
Time Frame Baseline (Day 0), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants who completed the questionnaire at baseline and week 24.
Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 152 122 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.4  (26.05) -1.5  (32.50) -2.6  (31.61)
8.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Emotional Functioning Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of emotional functioning.
Time Frame Baseline (Day 0), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants who completed the questionnaire at baseline and week 24.
Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 151 123 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.2  (15.92) -4.0  (19.17) -0.7  (27.32)
9.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Cognitive Functioning Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of cognitive functioning.
Time Frame Baseline (Day 0), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants who completed the questionnaire at baseline and week 24.
Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 152 123 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.9  (19.61) -4.9  (23.06) 3.5  (16.96)
10.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Social Functioning Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better level of social functioning.
Time Frame Baseline (Day 0), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants who completed the questionnaire at baseline and week 24.
Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 152 123 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
-5.2  (26.25) -5.3  (29.67) -3.1  (30.72)
11.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Fatigue Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the fatigue scale = higher level of symptomatology/problems.
Time Frame Baseline (Day 0), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants who completed the questionnaire at baseline and week 24.
Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 152 123 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.6  (20.93) 5.3  (26.59) 1.0  (22.07)
12.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Pain Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the pain scale = higher level of symptomatology/problems.
Time Frame Baseline (Day 0), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants who completed the questionnaire at baseline and week 24.
Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 153 125 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.9  (25.56) -5.2  (28.35) -6.6  (32.77)
13.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Nausea/Vomiting Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the nausea/vomiting scale = higher level of symptomatology/problems.
Time Frame Baseline (Day 0), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants who completed the questionnaire at baseline and week 24.
Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 152 123 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.0  (13.99) 0.1  (17.14) -2.2  (19.82)
14.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Constipation Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the constipation scale = higher level of symptomatology/problems.
Time Frame Baseline (Day 0), Week 24
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis set of participants who completed the questionnaire at baseline and week 24.
Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
Hide Arm/Group Description:
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 150 123 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.1  (31.71) 7.9  (26.68) 2.6  (37.47)
15.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Diarrhea Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the diarrhea scale = higher level of symptomatology/problems.
Time Frame Baseline (Day 0), Week 24
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Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
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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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 151 123 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
8.6  (24.18) 8.1  (24.27) 9.0  (24.40)
16.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Insomnia Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the insomnia scale = higher level of symptomatology/problems.
Time Frame Baseline (Day 0), Week 24
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Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
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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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 151 123 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.8  (29.70) 2.2  (35.38) -1.8  (34.20)
17.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Dyspnoea Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the dyspnoea scale = higher level of symptomatology/problems.
Time Frame Baseline (Day 0), Week 24
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Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
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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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 148 122 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.7  (25.94) 2.7  (27.97) -0.9  (28.46)
18.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Appetite Loss Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a symptom scale like the appetite loss scale = higher level of symptomatology/problems.
Time Frame Baseline (Day 0), Week 24
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Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
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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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 152 123 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.4  (27.12) 3.3  (30.60) -4.5  (29.57)
19.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Financial Problems Scale
Hide Description EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score for a problem scale like the financial problems scale = higher level of financial problems.
Time Frame Baseline (Day 0), Week 24
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Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
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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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 152 121 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.0  (20.74) 0.8  (22.14) 0.9  (16.42)
20.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Quality of Life Scale
Hide Description EORTQ QLC-C30 is a 30-item questionnaire to assess the overall quality of life in cancer patients. Most questions used 4-point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores are averaged, and transformed to 0-100 scale; higher score = better quality of life.
Time Frame Baseline (Day 0), Week 24
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Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
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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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 152 122 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.1  (20.90) -1.8  (23.17) -2.2  (21.81)
21.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
Hide Description EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the disease symptoms scale = higher level of symptomatology.
Time Frame Baseline (Day 0), Week 24
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Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
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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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 151 122 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.4  (16.79) -1.2  (17.62) -3.9  (19.00)
22.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Scale
Hide Description EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale; higher score for the side effects scale = higher level of symptomatology.
Time Frame Baseline (Day 0), Week 24
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Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
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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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 151 121 37
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.9  (13.22) 4.7  (13.16) 2.0  (13.45)
23.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
Hide Description EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the future perspective scale, higher score = better perspective of the future.
Time Frame Baseline (Day 0), Week 24
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Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
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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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 150 119 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.8  (21.14) 3.4  (21.70) 4.4  (21.85)
24.Secondary Outcome
Title Change From Baseline to Week 24 in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale
Hide Description EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. Questions used 4-point scale (1 'Not at All' to 4 'Very Much'). Scores are averaged, and transformed to 0-100 scale. For the body image scale, higher scores = better body image.
Time Frame Baseline (Day 0), Week 24
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Arm/Group Title Lenalidomide - Subpopulation From Austria + Australia Lenalidomide - Subpopulation From UK + Ireland Lenalidomide - Subpopulation From Spain
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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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
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), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
Overall Number of Participants Analyzed 149 117 38
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.3  (35.15) -2.0  (33.42) -5.3  (31.51)
Time Frame Up to 123 weeks
Adverse Event Reporting Description A participant with multiple occurrences of a serious treatment-emergent adverse event (TEAE) was counted only once for that preferred term.
 
Arm/Group Title Lenalidomide Plus Dexamethasone
Hide Arm/Group Description 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), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
All-Cause Mortality
Lenalidomide Plus Dexamethasone
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide Plus Dexamethasone
Affected / at Risk (%)
Total   340/587 (57.92%) 
Blood and lymphatic system disorders   
Anaemia  1  31/587 (5.28%) 
Febrile neutropenia  1  22/587 (3.75%) 
Neutropenia  1  16/587 (2.73%) 
Thrombocytopenia  1  11/587 (1.87%) 
Pancytopenia  1  3/587 (0.51%) 
Leukopenia  1  2/587 (0.34%) 
Coagulopathy  1  1/587 (0.17%) 
Haemolytic anaemia  1  1/587 (0.17%) 
Lymphopenia  1  1/587 (0.17%) 
Cardiac disorders   
Atrial fibrillation  1  12/587 (2.04%) 
Cardiac failure  1  7/587 (1.19%) 
Acute myocardial infarction  1  4/587 (0.68%) 
Angina unstable  1  3/587 (0.51%) 
Angina pectoris  1  2/587 (0.34%) 
Atrial flutter  1  2/587 (0.34%) 
Cardio-respiratory arrest  1  2/587 (0.34%) 
Left ventricular failure  1  2/587 (0.34%) 
Acute coronary syndrome  1  1/587 (0.17%) 
Atrial thrombosis  1  1/587 (0.17%) 
Bradycardia  1  1/587 (0.17%) 
Cardiac failure congestive  1  1/587 (0.17%) 
Cardiopulmonary failure  1  1/587 (0.17%) 
Myocardial infarction  1  1/587 (0.17%) 
Myocardial ischaemia  1  1/587 (0.17%) 
Supraventricular tachycardia  1  1/587 (0.17%) 
Tachycardia  1  1/587 (0.17%) 
Endocrine disorders   
Steroid withdrawal syndrome  1  2/587 (0.34%) 
Hyperparathyroidism  1  1/587 (0.17%) 
Hyperthyroidism  1  1/587 (0.17%) 
Eye disorders   
Vision blurred  1  1/587 (0.17%) 
Gastrointestinal disorders   
Diarrhoea  1  7/587 (1.19%) 
Abdominal pain  1  5/587 (0.85%) 
Vomiting  1  4/587 (0.68%) 
Intestinal obstruction  1  3/587 (0.51%) 
Rectal haemorrhage  1  2/587 (0.34%) 
Abdominal pain lower  1  1/587 (0.17%) 
Abdominal pain upper  1  1/587 (0.17%) 
Abdominal strangulated hernia  1  1/587 (0.17%) 
Diverticular perforation  1  1/587 (0.17%) 
Dyspepsia  1  1/587 (0.17%) 
Enterovesical fistula  1  1/587 (0.17%) 
Gastritis  1  1/587 (0.17%) 
Gastrointestinal haemorrhage  1  1/587 (0.17%) 
Haematemesis  1  1/587 (0.17%) 
Intestinal perforation  1  1/587 (0.17%) 
Large intestinal obstruction  1  1/587 (0.17%) 
Large intestine perforation  1  1/587 (0.17%) 
Nausea  1  1/587 (0.17%) 
Oesophageal haemorrhage  1  1/587 (0.17%) 
Oesophagitis  1  1/587 (0.17%) 
Pancreatitis  1  1/587 (0.17%) 
Pancreatitis acute  1  1/587 (0.17%) 
Peritonitis  1  1/587 (0.17%) 
Retroperitoneal haematoma  1  1/587 (0.17%) 
Small intestinal obstruction  1  1/587 (0.17%) 
General disorders   
Pyrexia  1  30/587 (5.11%) 
Fatigue  1  9/587 (1.53%) 
Oedema peripheral  1  6/587 (1.02%) 
General physical health deterioration  1  4/587 (0.68%) 
Non-cardiac chest pain  1  4/587 (0.68%) 
Pain  1  3/587 (0.51%) 
Asthenia  1  1/587 (0.17%) 
Chest pain  1  1/587 (0.17%) 
Death  1  1/587 (0.17%) 
Disease progression  1  1/587 (0.17%) 
Drug interaction  1  1/587 (0.17%) 
Hyperplasia  1  1/587 (0.17%) 
Malaise  1  1/587 (0.17%) 
Multi-organ failure  1  1/587 (0.17%) 
Sudden death  1  1/587 (0.17%) 
Hepatobiliary disorders   
Cholecystitis  1  1/587 (0.17%) 
Cholelithiasis  1  1/587 (0.17%) 
Hepatic failure  1  1/587 (0.17%) 
Hepatic function abnormal  1  1/587 (0.17%) 
Immune system disorders   
Drug hypersensitivity  1  1/587 (0.17%) 
Infections and infestations   
Pneumonia  1  52/587 (8.86%) 
Lower respiratory tract infection  1  38/587 (6.47%) 
Sepsis  1  17/587 (2.90%) 
Respiratory tract infection  1  15/587 (2.56%) 
Cellulitis  1  14/587 (2.39%) 
Infection  1  7/587 (1.19%) 
Neutropenic sepsis  1  6/587 (1.02%) 
Upper respiratory tract infection  1  6/587 (1.02%) 
Urinary tract infection  1  6/587 (1.02%) 
Lobar pneumonia  1  5/587 (0.85%) 
Septic shock  1  5/587 (0.85%) 
Bronchitis  1  4/587 (0.68%) 
Gastroenteritis  1  4/587 (0.68%) 
Infective exacerbation of chronic obstructive airways disease  1  3/587 (0.51%) 
Lung infection pseudomonal  1  3/587 (0.51%) 
Arthritis bacterial  1  2/587 (0.34%) 
Bacteraemia  1  2/587 (0.34%) 
Bacterial sepsis  1  2/587 (0.34%) 
Bronchopneumonia  1  2/587 (0.34%) 
Febrile infection  1  2/587 (0.34%) 
Oral candidiasis  1  2/587 (0.34%) 
Pneumocystis jiroveci pneumonia  1  2/587 (0.34%) 
Staphylococcal sepsis  1  2/587 (0.34%) 
Abscess limb  1  1/587 (0.17%) 
Abscess oral  1  1/587 (0.17%) 
Anal infection  1  1/587 (0.17%) 
Appendicitis  1  1/587 (0.17%) 
Bacterial infection  1  1/587 (0.17%) 
Brain abscess  1  1/587 (0.17%) 
Bronchiolitis  1  1/587 (0.17%) 
Bronchitis acute  1  1/587 (0.17%) 
Bronchitis moraxella  1  1/587 (0.17%) 
Catheter related infection  1  1/587 (0.17%) 
Cellulitis staphylococcal  1  1/587 (0.17%) 
Central line infection  1  1/587 (0.17%) 
Cholecystitis infection  1  1/587 (0.17%) 
Clostridial infection  1  1/587 (0.17%) 
Diverticulitis  1  1/587 (0.17%) 
Endocarditis  1  1/587 (0.17%) 
Escherichia urinary tract infection  1  1/587 (0.17%) 
Eye infection  1  1/587 (0.17%) 
Fungal infection  1  1/587 (0.17%) 
Gastroenteritis viral  1  1/587 (0.17%) 
Herpes zoster  1  1/587 (0.17%) 
Herpes zoster disseminated  1  1/587 (0.17%) 
Influenza  1  1/587 (0.17%) 
Joint abscess  1  1/587 (0.17%) 
Legionella infection  1  1/587 (0.17%) 
Listeria sepsis  1  1/587 (0.17%) 
Localised infection  1  1/587 (0.17%) 
Meningitis streptococcal  1  1/587 (0.17%) 
Necrotising fasciitis  1  1/587 (0.17%) 
Neutropenic infection  1  1/587 (0.17%) 
Opportunistic infection  1  1/587 (0.17%) 
Orchitis  1  1/587 (0.17%) 
Parotitis  1  1/587 (0.17%) 
Perianal abscess  1  1/587 (0.17%) 
Pilonidal cyst  1  1/587 (0.17%) 
Pneumonia legionella  1  1/587 (0.17%) 
Pneumonia moraxella  1  1/587 (0.17%) 
Pneumonia staphylococcal  1  1/587 (0.17%) 
Pseudomonal bacteraemia  1  1/587 (0.17%) 
Staphylococcal bacteraemia  1  1/587 (0.17%) 
Subacute endocarditis  1  1/587 (0.17%) 
Tooth abscess  1  1/587 (0.17%) 
Tooth infection  1  1/587 (0.17%) 
Urosepsis  1  1/587 (0.17%) 
Injury, poisoning and procedural complications   
Fall  1  5/587 (0.85%) 
Accidental overdose  1  2/587 (0.34%) 
Femur fracture  1  2/587 (0.34%) 
Humerus fracture  1  2/587 (0.34%) 
Compression fracture  1  1/587 (0.17%) 
Drug toxicity  1  1/587 (0.17%) 
Femoral neck fracture  1  1/587 (0.17%) 
Foreign body trauma  1  1/587 (0.17%) 
Gastrointestinal stoma complication  1  1/587 (0.17%) 
Head injury  1  1/587 (0.17%) 
Jaw fracture  1  1/587 (0.17%) 
Lower limb fracture  1  1/587 (0.17%) 
Multiple fractures  1  1/587 (0.17%) 
Muscle rupture  1  1/587 (0.17%) 
Radius fracture  1  1/587 (0.17%) 
Rib fracture  1  1/587 (0.17%) 
Road traffic accident  1  1/587 (0.17%) 
Spinal compression fracture  1  1/587 (0.17%) 
Wrist fracture  1  1/587 (0.17%) 
Investigations   
Blood creatinine increased  1  5/587 (0.85%) 
International normalised ratio increased  1  2/587 (0.34%) 
Blood alkaline phosphatase increased  1  1/587 (0.17%) 
Blood bilirubin increased  1  1/587 (0.17%) 
Blood calcium decreased  1  1/587 (0.17%) 
Blood creatinine increased  1  1/587 (0.17%) 
Blood creatine phosphokinase increased  1  1/587 (0.17%) 
Blood culture positive  1  1/587 (0.17%) 
Gamma-glutamyltransferase increased  1  1/587 (0.17%) 
Hepatic enzyme increased  1  1/587 (0.17%) 
Prostatic specific antigen increased  1  1/587 (0.17%) 
Metabolism and nutrition disorders   
Dehydration  1  14/587 (2.39%) 
Hyperglycaemia  1  8/587 (1.36%) 
Hypercalcaemia  1  4/587 (0.68%) 
Hypocalcaemia  1  4/587 (0.68%) 
Hypokalaemia  1  2/587 (0.34%) 
Fluid overload  1  1/587 (0.17%) 
Hypoalbuminaemia  1  1/587 (0.17%) 
Hypophosphataemia  1  1/587 (0.17%) 
Tetany  1  1/587 (0.17%) 
Vitamin D deficiency  1  1/587 (0.17%) 
Musculoskeletal and connective tissue disorders   
Back pain  1  11/587 (1.87%) 
Muscular weakness  1  9/587 (1.53%) 
Arthralgia  1  5/587 (0.85%) 
Bone pain  1  4/587 (0.68%) 
Musculoskeletal chest pain  1  3/587 (0.51%) 
Myopathy  1  3/587 (0.51%) 
Osteonecrosis  1  3/587 (0.51%) 
Pain in extremity  1  2/587 (0.34%) 
Fistula  1  1/587 (0.17%) 
Groin pain  1  1/587 (0.17%) 
Haemarthrosis  1  1/587 (0.17%) 
Lumbar spinal stenosis  1  1/587 (0.17%) 
Musculoskeletal pain  1  1/587 (0.17%) 
Neck pain  1  1/587 (0.17%) 
Osteoarthritis  1  1/587 (0.17%) 
Pathological fracture  1  1/587 (0.17%) 
Rhabdomyolysis  1  1/587 (0.17%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Multiple myeloma  1  39/587 (6.64%) 
Adenocarcinoma  1  1/587 (0.17%) 
Basosquamous carcinoma of skin  1  1/587 (0.17%) 
Benign lung neoplasm  1  1/587 (0.17%) 
Bladder cancer  1  1/587 (0.17%) 
Colon cancer  1  1/587 (0.17%) 
Gastrointestinal cancer metastatic  1  1/587 (0.17%) 
Metastatic neoplasm  1  1/587 (0.17%) 
Myelodysplastic syndrome  1  1/587 (0.17%) 
Myeloma recurrence  1  1/587 (0.17%) 
Neoplasm progression  1  1/587 (0.17%) 
Nervous system disorders   
Dizziness  1  5/587 (0.85%) 
Syncope  1  4/587 (0.68%) 
Lethargy  1  3/587 (0.51%) 
Syncope vasovagal  1  3/587 (0.51%) 
Transient ischaemic attack  1  3/587 (0.51%) 
Cerebrovascular accident  1  2/587 (0.34%) 
Loss of consciousness  1  2/587 (0.34%) 
Somnolence  1  2/587 (0.34%) 
Spinal cord compression  1  2/587 (0.34%) 
Tremor  1  2/587 (0.34%) 
Cerebral haemorrhage  1  1/587 (0.17%) 
Convulsion  1  1/587 (0.17%) 
Cranial nerve paralysis  1  1/587 (0.17%) 
Encephalopathy  1  1/587 (0.17%) 
Neuralgia  1  1/587 (0.17%) 
Phantom pain  1  1/587 (0.17%) 
Polyneuropathy  1  1/587 (0.17%) 
Serotonin syndrome  1  1/587 (0.17%) 
Psychiatric disorders   
Confusional state  1  13/587 (2.21%) 
Agitation  1  2/587 (0.34%) 
Depression  1  2/587 (0.34%) 
Hallucination  1  1/587 (0.17%) 
Korsakoff's psychosis alcoholic  1  1/587 (0.17%) 
Panic attack  1  1/587 (0.17%) 
Psychotic disorder  1  1/587 (0.17%) 
Renal and urinary disorders   
Renal failure acute  1  16/587 (2.73%) 
Renal failure  1  8/587 (1.36%) 
Renal impairment  1  7/587 (1.19%) 
Bladder disorder  1  1/587 (0.17%) 
Haematuria  1  1/587 (0.17%) 
Obstructive uropathy  1  1/587 (0.17%) 
Proteinuria  1  1/587 (0.17%) 
Renal failure chronic  1  1/587 (0.17%) 
Renal mass  1  1/587 (0.17%) 
Renal tubular acidosis  1  1/587 (0.17%) 
Urinary retention  1  1/587 (0.17%) 
Reproductive system and breast disorders   
Benign prostatic hyperplasia  1  1/587 (0.17%) 
Oedema genital  1  1/587 (0.17%) 
Pelvic pain  1  1/587 (0.17%) 
Respiratory, thoracic and mediastinal disorders   
Pulmonary embolism  1  22/587 (3.75%) 
Dyspnoea  1  8/587 (1.36%) 
Pleural effusion  1  4/587 (0.68%) 
Respiratory failure  1  4/587 (0.68%) 
Acute pulmonary oedema  1  3/587 (0.51%) 
Acute respiratory distress syndrome  1  2/587 (0.34%) 
Asthma  1  2/587 (0.34%) 
Dyspnoea exertional  1  2/587 (0.34%) 
Epistaxis  1  2/587 (0.34%) 
Pneumonitis  1  2/587 (0.34%) 
Bronchial hyperactivity  1  1/587 (0.17%) 
Bronchospasm  1  1/587 (0.17%) 
Chronic obstructive pulmonary disease  1  1/587 (0.17%) 
Cough  1  1/587 (0.17%) 
Lung infiltration  1  1/587 (0.17%) 
Productive cough  1  1/587 (0.17%) 
Respiratory arrest  1  1/587 (0.17%) 
Skin and subcutaneous tissue disorders   
Rash  1  2/587 (0.34%) 
Decubitus ulcer  1  1/587 (0.17%) 
Vascular disorders   
Deep vein thrombosis  1  25/587 (4.26%) 
Hypotension  1  5/587 (0.85%) 
Orthostatic hypotension  1  4/587 (0.68%) 
Arterial thrombosis limb  1  1/587 (0.17%) 
Circulatory collapse  1  1/587 (0.17%) 
Embolism  1  1/587 (0.17%) 
Hypertension  1  1/587 (0.17%) 
Phlebitis superficial  1  1/587 (0.17%) 
Shock  1  1/587 (0.17%) 
Thrombosis  1  1/587 (0.17%) 
Vasculitis  1  1/587 (0.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lenalidomide Plus Dexamethasone
Affected / at Risk (%)
Total   579/587 (98.64%) 
Blood and lymphatic system disorders   
Neutropenia  1  243/587 (41.40%) 
Anaemia  1  154/587 (26.24%) 
Thrombocytopenia  1  125/587 (21.29%) 
Eye disorders   
Vision blurred  1  55/587 (9.37%) 
Gastrointestinal disorders   
Constipation  1  194/587 (33.05%) 
Diarrhoea  1  180/587 (30.66%) 
Nausea  1  98/587 (16.70%) 
Vomiting  1  47/587 (8.01%) 
Dyspepsia  1  41/587 (6.98%) 
Dry mouth  1  34/587 (5.79%) 
Mouth ulceration  1  31/587 (5.28%) 
General disorders   
Fatigue  1  249/587 (42.42%) 
Oedema peripheral  1  101/587 (17.21%) 
Pyrexia  1  58/587 (9.88%) 
Asthenia  1  52/587 (8.86%) 
Infections and infestations   
Upper respiratory tract infection  1  92/587 (15.67%) 
Lower respiratory tract infection  1  67/587 (11.41%) 
Nasopharyngitis  1  64/587 (10.90%) 
Respiratory tract infection  1  32/587 (5.45%) 
Urinary tract infection  1  32/587 (5.45%) 
Investigations   
Weight decreased  1  33/587 (5.62%) 
Metabolism and nutrition disorders   
Anorexia  1  48/587 (8.18%) 
Hyperglycaemia  1  48/587 (8.18%) 
Hypocalcaemia  1  35/587 (5.96%) 
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  202/587 (34.41%) 
Muscular weakness  1  84/587 (14.31%) 
Back pain  1  83/587 (14.14%) 
Arthralgia  1  56/587 (9.54%) 
Pain in extremity  1  43/587 (7.33%) 
Musculoskeletal chest pain  1  40/587 (6.81%) 
Myalgia  1  33/587 (5.62%) 
Shoulder pain  1  31/587 (5.28%) 
Bone pain  1  30/587 (5.11%) 
Nervous system disorders   
Tremor  1  113/587 (19.25%) 
Dizziness  1  87/587 (14.82%) 
Lethargy  1  74/587 (12.61%) 
Headache  1  67/587 (11.41%) 
Dysgeusia  1  63/587 (10.73%) 
Neuropathy peripheral  1  46/587 (7.84%) 
Paraesthesia  1  46/587 (7.84%) 
Neuropathy  1  35/587 (5.96%) 
Peripheral sensory neuropathy  1  33/587 (5.62%) 
Psychiatric disorders   
Insomnia  1  173/587 (29.47%) 
Mood altered  1  53/587 (9.03%) 
Confusional state  1  40/587 (6.81%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  96/587 (16.35%) 
Cough  1  75/587 (12.78%) 
Epistaxis  1  43/587 (7.33%) 
Pharyngolaryngeal pain  1  39/587 (6.64%) 
Skin and subcutaneous tissue disorders   
Rash  1  81/587 (13.80%) 
Hyperhidrosis  1  33/587 (5.62%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (9.0)
This study was defined primarily as an expanded access program in the selected countries. Treatment was to continue until disease progression, study drug was discontinued for any reason, or lenalidomide became commercially available for indication.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
  • 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 180 days.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Associate Director, Clinical Trials Disclosure
Organization: Celgene Corporation
Phone: 1-888-260-1599
EMail: clinicaltrialdisclosure@celgene.com
Publications of Results:
Yong K, Alegre Amor A, Browne P, Cavenagh J, Dodds T, Greil R, et al. A Multicenter, Single-arm, Open-label Safety and Quality of Life Study of Lenalidomide plus Dexamethasone in previously treated Patients with Multiple Myeloma. Haematologica 2010;95(suppl.2):392, abs. 0944.
Layout table for additonal information
Responsible Party: Celgene ( Celgene Corporation )
ClinicalTrials.gov Identifier: NCT00420849     History of Changes
Other Study ID Numbers: CC-5013-MM-018
2006-002517-12 ( EudraCT Number )
First Submitted: January 9, 2007
First Posted: January 11, 2007
Results First Submitted: February 10, 2012
Results First Posted: March 14, 2012
Last Update Posted: May 21, 2012