Overview

This trial is active, not recruiting.

Condition anemia
Treatments lenalidomide, placebo
Phase phase 3
Sponsor Celgene Corporation
Start date January 2010
End date March 2014
Trial size 239 participants
Trial identifier NCT01029262, CC-5013-MDS-005

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Lenalidomide 10 mg by mouth (PO) daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent. Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min.
lenalidomide Revlimid
One 10 mg Lenalidomide capsule + 2 placebo capsules or (3 placebo capsules) once daily for subjects with a creatinine clearance ≥ 60 mL/min. Alternatively-one 5 mg Lenalidomide capsule + 2 placebo capsules (or 3 placebo capsules) once daily for subjects with a creatinine clearance between 40 and 60 mL/min. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)
(Placebo Comparator)
Three placebo capsules once daily for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
placebo
3 placebo capsules once daily. Subjects may take study drug for at least 168 days unless there are intolerable side effects or disease progresses. Subjects may continue study drug beyond 168 days if they have an erythroid response (increase in their hemoglobin levels and fewer transfusions administered than before starting study drug)

Primary Outcomes

Measure
Percentage of Participants Who Achieved Red Blood Cell (RBC) Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)
time frame: Up to 49 months; From randomization to the data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days
Percentage of Participants With a Erythroid Gene Signature Who Achieved RBC Transfusion Independence for ≥ 56 Days as Determined by an Independent Review Committee (IRC)
time frame: Up to 49 months; Up to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days

Secondary Outcomes

Measure
Percentage of Participants Who Achieved RBC Transfusion Independence With a Duration of ≥ 24 Weeks (168 Days) as Determined by the Sponsor
time frame: Up to 49 months; From randomization to the data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days
Kaplan Meier Estimates of Duration of 56-day RBC TI Response as Determined by the Sponsor
time frame: Up to 49 months; from randomization to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days
Percentage of Participants Who Achieved an Erythroid Response Based on Modified International Working Group (IWG) 2006 Criteria
time frame: Up to 49 months; From Randomization to Data Cut-Off 17 March 2014; Maximum exposure on study drug was1158 days
Time to 56-Day RBC-Transfusion-independent Response as Determined by the Sponsor
time frame: From the first dose of study drug to Day 56
Kaplan Meier Estimates for Progression to Acute Myeloid Leukemia (AML)
time frame: Up to 49 months; From Randomization to Data Cut-Off 17 March 2014; Maximum exposure to study drug was 1158 days
Kaplan Meier Estimate for Overall Survival (OS)
time frame: Up to 49 months; From randomization to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days
Number of Participants With Treatment Emergent Adverse Events (TEAE)
time frame: From the first dose of study drug through 28 days after discontinuation from the study treatment; up to data cut-off of 17 Mar 2014; maximum exposure to study drug was 1158 days
Compliance Rates Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) From Baseline to Week 48
time frame: 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
Mean Change From Baseline in the EORTC QLQ-C30 Fatigue Domain at Week 12 and 24
time frame: Baseline and Week 12, ±3 days and Week 24, ±3 days
Mean Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain at Week 12 and 24
time frame: Baseline and Week 12, ±3 days and Week 24, ±3 days
Mean Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain at Week 12 and 24
time frame: Baseline and Week 12, ±3 days and Week 24, ±3 days
Mean Change From Baseline in the EORTC QLQ-C30 Global Health Status/Quality of Life (QOL) Domain at Week 12 and 24
time frame: Baseline and Week 12, ±3 days and Week 24, ±3 days
Mean Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain at Week 12 and 24
time frame: Baseline and Week 12, ±3 days and Week 24, ±3 days
Mean Change From Baseline in Fatigue Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24
time frame: Baseline, Week 12, ±3 days and Week 24, ±3 days
Mean Change From Baseline in the Dyspnea Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24
time frame: Baseline, Week 12, ±3 days and Week 24, ±3 days
Mean Change From Baseline in the Physical Functioning Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24
time frame: Baseline, Week 12, ±3 days and Week 24, ±3 days
Mean Change From Baseline in the Global Health Status/QoL Domain Associated With the EORTC QLQ-C-30 Scale at Week 12 and Week 24
time frame: Baseline, Week 12, ±3 days and Week 24, ±3 days
Mean Change From Baseline in the Emotional Functioning Domain Associated With the EORTC QLQ-C30 Scale at Weeks 12 and 24
time frame: Baseline, Week 12, ±3 days and Week 24, ±3 days
Percentage of Participants With a Clinically Meaningful Improvement in QOL (EORTC QLQ-C-30 Scale) From Baseline in Fatigue Domain at Weeks 12 and 24
time frame: Baseline, Week 12, ±3 days and Week 24, ±3 days
Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Dyspnea Domain at Weeks 12 and 24
time frame: Baseline, Week 12, ±3 days and Week 24, ±3 days
Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline Within the Physical Functioning Domain at Weeks 12 and 24
time frame: Baseline, Week 12, ±3 days and Week 24, ±3 days
Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Global Health Status/QOL Domain at Weeks 12 and 24
time frame: Baseline, Week 12, ±3 days and Week 24, ±3 days
Percentage of Participants With a Clinically Meaningful Improvement in HRQOL Associated With the EORTC QLQ-C-30 Scale From Baseline in the Emotional Functioning Domain at Weeks 12 and 24
time frame: Baseline, Week 12, ±3 days and Week 24, ±3 days
Healthcare Resource Utilization (HRU): Rate of Inpatient Hospitalizations, Concomitant Procedures/Surgeries and the Differences Between Treatment Arms
time frame: Up to 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 18 years or older - Diagnosis of low or intermediate-1 risk Myelodysplastic (MDS) with any chromosome karyotype except del 5q[31] - Anemia that requires red blood cell transfusions - Resistant to erythropoiesis stimulating agents (ESAs) or blood erythropoietin level > 500 mU/mL - Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2 - Must agree to follow pregnancy precautions as required by the protocol. - Must agree to receive counseling related to teratogenic and other risks of lenalidomide - Must agree not to donate blood or semen - Must be willing to consent to two or more bone marrow aspirate procedures to be completed during study Exclusion Criteria: - Subjects previously receiving immunomodulating or immunosuppressive agents, or epigenetic or deoxyribonucleic acid (DNA) modulation agents - Allergic reaction to thalidomide - Renal insufficiency creatinine clearance (CrC1)<40 mL/min by Cockcroft-Gault method) - Prior history of cancer, other than MDS, unless the subject has been free of the disease for ≥ 5 years. (Basal cell carcinoma of the skin, carcinoma in situ of the cervix, or stage Tumor (T) 1a or T1b prostate cancer is allowed) - Absolute neutrophil count (ANC) < 500/uL - Platelets < 50,000/uL - Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3X upper limit of normal - Uncontrolled hyperthyroidism or hypothyroidism - Significant neuropathy - Prior stem cell transplantation - Anemia due to reasons other than MDS - History of deep venous thrombosis (DVT) or pulmonary embolus (PE) within past 3 years - Significant active cardiac disease within the past 6 months - Known Human Immunodeficiency Virus (HIV) infection; known Hepatitis C infection or active Hepatitis B infection

Additional Information

Official title PHASE 3B, RANDOMIZED TRIAL OF REVLIMID® (LENALIDOMIDE) VERSUS PLACEBO MAINTENANCE THERAPY FOLLOWING MELPHALAN PREDNISONE VELCADE® (BORTEZOMIB) INDUCTION THERAPY IN NEWLY DIAGNOSED MULTIPLE MYELOMA
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Celgene Corporation.