18 and older, any sex, with Anemia. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)Primary· From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
The percentage of participants who achieved the 56-day RBC transfusion independent (TI) response was defined as the absence of any RBC transfusions during any consecutive "rolling" 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). The double-blind treatment phase was defined as the period between the 1st dosing up until 28 days after the last study drug dose
Group
Value
95% CI
Placebo
2.5
Lenalidomide
26.9
Percentage of Participants With a Erythroid Gene Signature Who Achieved RBC Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)Primary· From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
The percentage of participants who achieved the 56-day RBC TI response was defined as the absence of any RBC transfusions during any consecutive "rolling" 56-day interval within the double-blind treatment phase (ie, Days 2 (Day 1 is the first study drug day) to 57, Days 3 to 58, etcetera). A participant who achieved at least a 56-day RBC-transfusion-independent response was considered a 56-day RBC-TI responder.
Group
Value
95% CI
Placebo
0.0
Lenalidomide
7.1
Percentage of Participants Who Achieved RBC Transfusion Independence With a Duration of ≥ 24 Weeks (168 Days) as Determined by the SponsorSecondary· From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
The 168-day RBC-transfusion-independent response was defined as the absence of any RBC transfusion during any consecutive "rolling" 168 days during the treatment period, for example Days 2 (Day 1 is the first study drug day) to 169, Days 3 to 170, Days 4 to 171, etcetera. A responder was defined as a participant who had a ≥ 168 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase.
Group
Value
95% CI
Placebo
0.0
Lenalidomide
17.5
Kaplan Meier Estimates of Duration of 56-day RBC Transfusion Independence Response as Determined by the SponsorSecondary· Response was assessed up to the end of treatment; up to the data cut-off date of 17 Mar 2014.
The duration of the first 56-day RBC transfusion-independence response was calculated for those who achieved a response and was dependent on whether a subsequent RBC transfusion was given after the transfusion-free period (response):
* For those who received a subsequent RBC transfusion after the response starts, the duration of response was not censored, and was calculated as response duration = last day of response - first day of response +1 where the last day of response was defined as 1 day before the first RBC transfusion which was given at 56 days or more after the response starts.
* Fo
Group
Value
95% CI
Placebo
NA
NA – NA
Lenalidomide
30.9
20.7 – 59.1
Percentage of Participants Who Achieved an Erythroid Response Based on the Modified International Working Group (IWG) 2006 CriteriaSecondary· From first dose of study drug until 28 days after the last dose, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
A participant was considered as having achieved an erythroid response if the participant either:
\- had a hemoglobin (Hgb) increase ≥1.5 g/dL compared to baseline and confirmed by another central laboratory hemoglobin value at 4 to 8 weeks after the first Hgb measurement that also increased ≥1.5 g/dL. All Hgb values during this time interval must have had a ≥ 1.5 g/dL increase (ie, no central laboratory Hgb increase during this timeframe could be less \<1.5 g/dL) OR - had a 50% reduction in the number of the RBC transfusion units over any consecutive 56 days period compared to the baseline tr
Group
Value
95% CI
Placebo
30.4
Lenalidomide
38.8
Time to 56-Day RBC-Transfusion-Independent (TI) Response as Determined by the SponsorSecondary· From first dose of study drug until 28 days after the last dose of study drug, as of the data cut-off date of 17 March 2014; median (minimum, maximum) duration of treatment was 168 (14, 449) and 164 (7, 1158) days in each treatment group respectively.
The time to the first 56-day RBC-transfusion-independent response was calculated for participants who achieved a response. The day from the first dose of study drug to the date at which RBC-transfusion-independence starts was achieved and calculated using: Start date of the first response period - the date of the first study drug +1. A responder was defined as a participant who had a ≥ 56 consecutive days of RBC-transfusion-free period after the first dose of study drug in the treatment phase.
Group
Value
95% CI
Placebo
0.3
0.3 – 0.3
Lenalidomide
10.1
0.3 – 23.6
Kaplan Meier Estimates for Progression to Acute Myeloid Leukemia (AML)Secondary· From randomization to final data cut-off date of 03 Jul 2018; median follow up time for progression to AML was 2.3 years (range = 0 to 5.0 years) in the placebo arm and 2.6 years (range = 0 to 6.4 years) in the lenalidomide arm.
Progression to AML is part of the natural course of MDS and is a manifestation of disease progression. The time to progress to AML was calculated from the day of randomization to the first day when AML was diagnosed. Participants who died without AML were censored at the date of death. The participants who were lost to follow-up were censored at the last known day when participants did not have AML. Participants who did not progress to AML at the last follow-up contact were censored at the day of the last follow-up contact.
Group
Value
95% CI
Placebo
NA
NA – NA
Lenalidomide
NA
5.2 – NA
Kaplan Meier Estimate for Overall Survival (OS)Secondary· From randomization to final data cut-off date of 03 July 2018; maximum survival follow up was 6.4 years
Overall survival was assessed using the time between randomization and the date of death or date of censoring. Participants who were alive at a data cutoff date and participants who were lost to follow-up were censored at the last date when participants were known to be alive.
Group
Value
95% CI
Placebo
3.0
2.3 – NA
Lenalidomide
3.8
2.9 – 4.8
Number of Participants With Treatment Emergent Adverse Events (TEAE)Secondary· From the first dose of study drug through 28 days after discontinuation from the study treatment; up to the final data cut-off date of 03 July 2018; maximum exposure was 2100 days in the lenalidomide arm and 529 days in the placebo arm.
A TEAE was defined as an AE that begins or worsens in intensity of frequency on or after the first dose of study drug through 28 days after last dose of study drug.
A serious adverse event (SAE) is any:
* Death;
* Life-threatening event;
* Any inpatient hospitalization or prolongation of existing hospitalization;
* Persistent or significant disability or incapacity;
* Congenital anomaly or birth defect;
* Any other important medical event
The investigator determined the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other
At least 1 TEAE
Group
Value
95% CI
Placebo
74
Lenalidomide
160
≥ 1 Treatment Related AE (TEAE)
Group
Value
95% CI
Placebo
42
Lenalidomide
144
≥ 1 Treatment related TEAE Causing Discontinuation
Group
Value
95% CI
Placebo
3
Lenalidomide
40
≥ 1 TEAE Leading to Dose Reduction
Group
Value
95% CI
Placebo
1
Lenalidomide
10
≥ 1 TEAE Leading to Dose Interruption
Group
Value
95% CI
Placebo
11
Lenalidomide
89
≥ 1 TEAE Leading to Dose Interruption & Reduction
Group
Value
95% CI
Placebo
5
Lenalidomide
68
≥ 1 TEAE Leading to Discontinuation of Study Drug
Group
Value
95% CI
Placebo
9
Lenalidomide
51
≥ 1 Serious TEAE
Group
Value
95% CI
Placebo
16
Lenalidomide
62
Compliance Rates Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) From Baseline to Week 48Secondary· Baseline, Week 12, (±3 days), Week 24, (±3 days), Week 36, (±3 days), and Week 48 (±3 days); up to data cut-off of 17 Mar 2014
The European Organization for Research and Treatment of Cancer QOL Questionnaire for Patients with Cancer (EORTC QLQ-C30) was a 30-item oncology-specific questionnaire. The questionnaire was developed to assess the quality of life of cancer patients. It contains 30 questions, 24 of which form 9 multi-item scales representing various aspects of HRQOL: 1 global scale, 5 functional scales (Physical, Role, Emotional, Cognitive and Social), and 3 symptom scales (Fatigue, Pain, and Nausea). The remaining 6 items are intended to be mono-item scales describing relevant cancer-oriented symptoms (dyspne
Baseline
Group
Value
95% CI
Placebo
88.6
Lenalidomide
90
Week 12
Group
Value
95% CI
Placebo
78.5
Lenalidomide
83.8
Week 24
Group
Value
95% CI
Placebo
80.6
Lenalidomide
85.8
Week 36
Group
Value
95% CI
Placebo
100
Lenalidomide
80.5
Week 48
Group
Value
95% CI
Placebo
50
Lenalidomide
71.9
Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain at Week 12 and 24Secondary· Baseline and Week 12, ±3 days and Week 24, ±3 days
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level o
Week 12
Group
Value
95% CI
Placebo
0.6
± 17.53
Lenalidomide
2.4
± 28.26
Week 24
Group
Value
95% CI
Placebo
7.6
± 20.74
Lenalidomide
-1.5
± 26.42
Mean Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain at Week 12 and 24Secondary· Baseline and Week 12, ±3 days and Week 24, ±3 days
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnea scale is scored between 0 and 100, with a high score indicating a higher level o
Week 12
Group
Value
95% CI
Placebo
0.6
± 28.06
Lenalidomide
2.2
± 29.92
Week 24
Group
Value
95% CI
Placebo
4.3
± 26.57
Lenalidomide
1.2
± 26.26
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first dose of study drug through 28 days after last dose; up to the final data cut-off date of 03 July 2018; maximum exposure was 2100 days in the lenalidomide treatment group and 529 days in the placebo group.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Placebo
Serious: 16/79 (20%)
Deaths: 43/79
Lenalidomide
Serious: 62/160 (39%)
Deaths: 94/160
Serious adverse events (91 terms)
Reaction
System
Placebo
Lenalidomide
PNEUMONIA
Infections and infestations
—
—
ANAEMIA
Blood and lymphatic system disorders
—
—
NEUTROPENIA
Blood and lymphatic system disorders
—
—
CARDIAC FAILURE
Cardiac disorders
—
—
NEUTROPENIC SEPSIS
Infections and infestations
—
—
PLEURAL EFFUSION
Respiratory, thoracic and mediastinal disorders
—
—
DEEP VEIN THROMBOSIS
Vascular disorders
—
—
ATRIAL FIBRILLATION
Cardiac disorders
—
—
MYOCARDIAL INFARCTION
Cardiac disorders
—
—
GENERAL PHYSICAL HEALTH DETERIORATION
General disorders
—
—
BRONCHITIS
Infections and infestations
—
—
CELLULITIS
Infections and infestations
—
—
URINARY TRACT INFECTION
Infections and infestations
—
—
FEMUR FRACTURE
Injury, poisoning and procedural complications
—
—
TRAUMATIC INTRACRANIAL HAEMORRHAGE
Injury, poisoning and procedural complications
—
—
ACUTE MYELOID LEUKAEMIA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
MYELODYSPLASTIC SYNDROME
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions (RBC) needed in anemic (RBC transfusion-dependent) participants with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study also investigated the safety of lenalidomide use in these participants. Two-thirds of the participants received oral lenalidomide and one-third of the participants received oral placebo.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 25 June 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01029262.