Lenalidomide Versus Placebo in Myelodysplastic Syndromes With a Deletion 5q[31] Abnormality
NCT ID: NCT00179621
Last Updated: 2011-04-14
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
205 participants
Study Classification
INTERVENTIONAL
Study Start Date
2005-07-31
Study Completion Date
2010-06-30
Brief Summary
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The purpose of this study was to compare 2 doses (10 mg and 5 mg) of lenalidomide to that of placebo in subjects with red blood cell (RBC) transfusion-dependent low- or intermediate-1-risk IPSS MDS associated with a deletion (del) 5q\[31\] cytogenetic abnormality. Study participants were randomized to one of the two treatment groups or to placebo and took the study drug for 16 weeks. At this timepoint, participants were evaluated for erythroid response. If participants did not achieve at least a minor erythroid response, they were discontinued from the Double-Blind phase and entered into the Open-Label phase. All erythroid responders at Week 16 were to continue in the Double-Blind phase for up to 52 weeks. For participants that were still responding at the end of Double-Blind phase, they could then rollover into the Open-Label phase for an additional two years. Participants could remain on study for up to a total of 3 years. All participants who discontinued from the study were followed every 4 months for overall survival and progression to acute myeloid leukemia (AML).
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Detailed Description
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MDS-004 was a multicenter, randomized, double-blind, placebo-controlled, 3-arm study of 2 doses of lenalidomide versus placebo administered to RBC transfusion-dependent adults with low- or intermediate-1 risk MDS associated with a del 5q\[31\] cytogentetic abnormality. Potential participants that had a del 5q\[31\] cytogenetic abnormality plus other additional cytogenetic abnormalities were also eligible for enrollment. Transfusion-dependent anemia was defined as documentation that a participant with anemia due to MDS did not have any consecutive 56 days (8 weeks) that were RBC transfusion free during at least the 112 days (16 weeks) prior to Day 1 of the Pre-Randomization Phase.
This study was conducted in three phases:
1. a Pre-Randomization Phase
2. a Double-Blind Treatment Phase
3. an Open-Label Extension Phase
Potentially protocol-eligible participants entered the Pre-Randomization Phase and were evaluated for the inclusion and exclusion criteria for the Double-Blind Treatment Phase. The Pre-Randomization Phase was not to last for more than 56 days (8 weeks). When the participant's baseline RBC transfusion requirement was calculated, and it had been determined that all eligibility criteria had been met, the participant could be randomized for treatment in the Double-Blind Treatment Phase at the time of their next RBC transfusion. This RBC transfusion had to occur within 56 days of the participant's last previous RBC transfusion.
Participants meeting eligibility criteria were randomized (1:1:1 ratio) to receive either lenalidomide 10 mg/day on days 1-21, lenalidomide 5 mg/day on days 1-28, or placebo on days 1-28; all on a 28-day cycle. Randomization was performed using a validated interactive voice response system. Participants were stratified according to karyotype (IPSS karyotype score: 0 vs \> 0; i.e., isolated del 5q\[31\] vs del 5q\[31\] plus ≥ 1 additional cytogenetic abnormality). A complete blood count (CBC), serum or plasma ferritin, and EPO levels were measured to determine baseline levels.
Participants who achieved at least a minor erythroid response (i.e. 50% decrease in transfusion requirements) by week 16 could continue treatment in the Double-Blind phase for up to 52 weeks, unless there was evidence of erythroid relapse, disease progression, or unacceptable toxicity. Those who did not achieve at least a minor erythroid response by week 16 were discontinued from the Double-Blind phase for lack of therapeutic efficacy, and unblinded and were potentially eligible for Open-Label treatment. All participants who completed the double-blind treatment phase (the first 52 weeks of the trial) without disease progression or erythroid relapse were unblinded and entered the Open-Label extension phase at their current lenalidomide dose. Participants in the placebo or lenalidomide 5 mg arms who failed to achieve at least a minor erythroid response by week 16 or who had an erythroid relapse could cross over to lenalidomide 5 mg or 10 mg, respectively, in the Open-Label Extension phase.
Lenalidomide treatment could be continued in the Open-label Extension phase for up to 3 years (156 weeks) of total study participation. Participants with disease progression at any time and participants in the lenalidomide 10 mg group who did not achieve at least a minor erythroid response by week 16 were withdrawn from the study and were ineligible for Open-Label treatment.
Serial measurements for efficacy and safety were performed every 28 days. In addition, CBCs were monitored weekly for the first 8 weeks, every 2 weeks for the next 8 weeks, and every 4 weeks thereafter. Bone marrow aspirate (BMA) and standard cytogenetic studies were performed at baseline, weeks 12, week 24, and every 24 weeks thereafter and when clinically indicated for assessment of disease progression. BMAs were submitted for central pathology review and sent to a central cytogenetics laboratory for processing and review. All participants were followed for overall survival (OS) and progression to acute myeloid leukemia (AML).
Lenalidomide or placebo dosing was reduced for dose-limiting toxicities according to the following dose reduction schedule:
* Lenalidomide 5 mg (starting dose)
* dose level -1 (5 mg every other day)
* dose level -2 (5 mg twice a week)
* dose level -3 (5 mg weekly)
* Lenalidomide 10 mg (starting dose)
* dose level -1 (5 mg daily)
* dose level -2 (5 mg every other day)
* dose level -3 (5 mg twice a week)
Participants who could not tolerate dose level -3 discontinued treatment. For grade 4 neutropenia, lenalidomide was required per protocol to be interrupted and resumed at a decreased dose level when the absolute neutrophil count (ANC) recovered to ≥ 500/μL. For grade 4 thrombocytopenia, lenalidomide was interrupted and then resumed at a decreased dose level when the platelet count recovered to: between ≥ 25,000/μL and \< 50,000/μL on at least 2 occasions for ≥ 7 days; or ≥ 50,000 at any time, respectively. Prophylactic and therapeutic use of granulocyte colony-stimulating factors (G-CSF) or granulocyte macrophage colony-stimulating factors (GM-CSF) was allowed.
This study was conducted in three phases:
1. a Pre-Randomization Phase
2. a Double-Blind Treatment Phase
3. an Open-Label Extension Phase
Potentially protocol-eligible participants entered the Pre-Randomization Phase and were evaluated for the inclusion and exclusion criteria for the Double-Blind Treatment Phase. The Pre-Randomization Phase was not to last for more than 56 days (8 weeks). When the participant's baseline RBC transfusion requirement was calculated, and it had been determined that all eligibility criteria had been met, the participant could be randomized for treatment in the Double-Blind Treatment Phase at the time of their next RBC transfusion. This RBC transfusion had to occur within 56 days of the participant's last previous RBC transfusion.
Participants meeting eligibility criteria were randomized (1:1:1 ratio) to receive either lenalidomide 10 mg/day on days 1-21, lenalidomide 5 mg/day on days 1-28, or placebo on days 1-28; all on a 28-day cycle. Randomization was performed using a validated interactive voice response system. Participants were stratified according to karyotype (IPSS karyotype score: 0 vs \> 0; i.e., isolated del 5q\[31\] vs del 5q\[31\] plus ≥ 1 additional cytogenetic abnormality). A complete blood count (CBC), serum or plasma ferritin, and EPO levels were measured to determine baseline levels.
Participants who achieved at least a minor erythroid response (i.e. 50% decrease in transfusion requirements) by week 16 could continue treatment in the Double-Blind phase for up to 52 weeks, unless there was evidence of erythroid relapse, disease progression, or unacceptable toxicity. Those who did not achieve at least a minor erythroid response by week 16 were discontinued from the Double-Blind phase for lack of therapeutic efficacy, and unblinded and were potentially eligible for Open-Label treatment. All participants who completed the double-blind treatment phase (the first 52 weeks of the trial) without disease progression or erythroid relapse were unblinded and entered the Open-Label extension phase at their current lenalidomide dose. Participants in the placebo or lenalidomide 5 mg arms who failed to achieve at least a minor erythroid response by week 16 or who had an erythroid relapse could cross over to lenalidomide 5 mg or 10 mg, respectively, in the Open-Label Extension phase.
Lenalidomide treatment could be continued in the Open-label Extension phase for up to 3 years (156 weeks) of total study participation. Participants with disease progression at any time and participants in the lenalidomide 10 mg group who did not achieve at least a minor erythroid response by week 16 were withdrawn from the study and were ineligible for Open-Label treatment.
Serial measurements for efficacy and safety were performed every 28 days. In addition, CBCs were monitored weekly for the first 8 weeks, every 2 weeks for the next 8 weeks, and every 4 weeks thereafter. Bone marrow aspirate (BMA) and standard cytogenetic studies were performed at baseline, weeks 12, week 24, and every 24 weeks thereafter and when clinically indicated for assessment of disease progression. BMAs were submitted for central pathology review and sent to a central cytogenetics laboratory for processing and review. All participants were followed for overall survival (OS) and progression to acute myeloid leukemia (AML).
Lenalidomide or placebo dosing was reduced for dose-limiting toxicities according to the following dose reduction schedule:
* Lenalidomide 5 mg (starting dose)
* dose level -1 (5 mg every other day)
* dose level -2 (5 mg twice a week)
* dose level -3 (5 mg weekly)
* Lenalidomide 10 mg (starting dose)
* dose level -1 (5 mg daily)
* dose level -2 (5 mg every other day)
* dose level -3 (5 mg twice a week)
Participants who could not tolerate dose level -3 discontinued treatment. For grade 4 neutropenia, lenalidomide was required per protocol to be interrupted and resumed at a decreased dose level when the absolute neutrophil count (ANC) recovered to ≥ 500/μL. For grade 4 thrombocytopenia, lenalidomide was interrupted and then resumed at a decreased dose level when the platelet count recovered to: between ≥ 25,000/μL and \< 50,000/μL on at least 2 occasions for ≥ 7 days; or ≥ 50,000 at any time, respectively. Prophylactic and therapeutic use of granulocyte colony-stimulating factors (G-CSF) or granulocyte macrophage colony-stimulating factors (GM-CSF) was allowed.
Conditions
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Myelodysplastic Syndromes
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Placebo
Placebo matching to active study arms.
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Placebo, matching to active study drug arms
Lenalidomide 5 mg
Lenalidomide 5 mg daily 28/28 days
Group Type
EXPERIMENTAL
Lenalidomide 5 mg
Intervention Type
DRUG
Lenalidomide 5 mg daily 28/28 days
Lenalidomide 10 mg
Lenalidomide 10 mg daily 21/28 days
Group Type
EXPERIMENTAL
Lenalidomide 10 mg
Intervention Type
DRUG
Lenalidomide 10 mg daily 21/28 days
Interventions
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Lenalidomide 5 mg
Lenalidomide 5 mg daily 28/28 days
Intervention Type
DRUG
Lenalidomide 10 mg
Lenalidomide 10 mg daily 21/28 days
Intervention Type
DRUG
Placebo
Placebo, matching to active study drug arms
Intervention Type
DRUG
Other Intervention Names
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Revlimid
Revlimid
Eligibility Criteria
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Inclusion Criteria
* Must understand and voluntarily sign an informed consent form
* Age 18 years at the time of signing the informed consent form
* Documented diagnosis of myelodysplastic syndromes (MDS) that meets International Prognostic Scoring System (IPSS) criteria for low to intermediate-1-risk disease and has an associated del 5q(31) cytogenetic abnormality
* Red blood cell (RBC) transfusion dependent anaemia defined as not having any 56 days without a RBC transfusion within at least the immediate 112 days
* Must be able to adhere to the study visit schedule and other protocol requirements
* Women of childbearing potential must have a negative pregnancy test prior to inclusion
* Age 18 years at the time of signing the informed consent form
* Documented diagnosis of myelodysplastic syndromes (MDS) that meets International Prognostic Scoring System (IPSS) criteria for low to intermediate-1-risk disease and has an associated del 5q(31) cytogenetic abnormality
* Red blood cell (RBC) transfusion dependent anaemia defined as not having any 56 days without a RBC transfusion within at least the immediate 112 days
* Must be able to adhere to the study visit schedule and other protocol requirements
* Women of childbearing potential must have a negative pregnancy test prior to inclusion
Exclusion Criteria
* Pregnant or lactating females
* Prior therapy with lenalidomide
* Proliferative (white blood cell (WBC)= 12,000/mL) chronic myelomonocytic leukemia (CMML)
* Prior \>= grade-2 (using the National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) (v 3.0)) allergic reaction to thalidomide
* Prior desquamating (blistering) rash while taking thalidomide
* Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for \>3 years
* Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 28 days
* Less than 6 months since prior allogeneic bone marrow transplantation
* Less than 3 months since prior autologous bone marrow or stem cell transplantation
* Less than 28 days since prior myelosuppressive anticancer biologic therapy
* Recombinant human erythropoietin (rHuEPO) therapy received within 28 days
* Known human immunodeficiency virus (HIV-1) positivity
* Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study
* Prior therapy with lenalidomide
* Proliferative (white blood cell (WBC)= 12,000/mL) chronic myelomonocytic leukemia (CMML)
* Prior \>= grade-2 (using the National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) (v 3.0)) allergic reaction to thalidomide
* Prior desquamating (blistering) rash while taking thalidomide
* Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for \>3 years
* Use of cytotoxic chemotherapeutic agents or experimental agents (agents that are not commercially available) for the treatment of MDS within 28 days
* Less than 6 months since prior allogeneic bone marrow transplantation
* Less than 3 months since prior autologous bone marrow or stem cell transplantation
* Less than 28 days since prior myelosuppressive anticancer biologic therapy
* Recombinant human erythropoietin (rHuEPO) therapy received within 28 days
* Known human immunodeficiency virus (HIV-1) positivity
* Any serious medical condition or psychiatric illness that will prevent the subject from signing the informed consent form or will place the subject at unacceptable risk if he or she participates in the study
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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ICON Clinical Research
INDUSTRY
Sponsor Role
collaborator
Celgene Corporation
INDUSTRY
Sponsor Role
lead
Responsible Party
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Celgene Corporation
Principal Investigators
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Jay Backstrom, MD
Role: STUDY_DIRECTOR
Celgene Corporation
Locations
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AZ St-Jan Brugge AV
Bruges, , Belgium
Site Status
UZ Gent
Ghent, , Belgium
Site Status
UZ Gasthuisberg
Leuven, , Belgium
Site Status
CHU Mont Godine
Yvoir, , Belgium
Site Status
Institut Paoli-Calmettes
Marseille, Cedex 9, France
Site Status
CHU d'Angers Service des Maladies du Sang
Angers, , France
Site Status
Hopital Avicenne
Bobigny, , France
Site Status
CHRU Lille Service des Maladies du Sang
Lille, , France
Site Status
CHU Nantes Hematologie et Medicine interne
Nantes, , France
Site Status
CHU Archet 1Hematologie Clinique
Nice, , France
Site Status
Hôpital Cochin Hematologie Clinique
Paris, , France
Site Status
Centre Jean Bernhard Service Onco-Hematologie
Poitiers, , France
Site Status
Centre Henri Becquerel Service d'Hematologie Clinique
Rouen, , France
Site Status
CHU Purpan, Place du Dr Baylac, Pavillon des Médecines
Toulouse, , France
Site Status
CHU Purpan, Place du Dr. Baylac, Pavillion des Medecines
Toulouse, , France
Site Status
CHU Nancy Hematologie et Medecine interne
Vandœuvre-lès-Nancy, , France
Site Status
Universitaetsklinikum Carl Gustav Carus
Dresden, , Germany
Site Status
St Johannes Hospital
Duisburg, , Germany
Site Status
Universitaetsklinikum Freiburg
Freiburg im Breisgau, , Germany
Site Status
Hannover Medical School
Hanover, , Germany
Site Status
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Site Status
Ospedale Niguarda Ca Granda
Milan, , Italy
Site Status
University of Pavia Division of Hematology
Pavia, , Italy
Site Status
University of Medical Centre
Nijmegen, , Netherlands
Site Status
Hematologie Erasmus MC
Rotterdam, , Netherlands
Site Status
Hospital Universitario de Salamanca
Salamanca, , Spain
Site Status
Hospital Universitario La Fe
Valencia, , Spain
Site Status
SU/Sahlgrenska Section of Hematology & Coagulation
Gothenburg, , Sweden
Site Status
Department of Medicine University Hospital
Lund, , Sweden
Site Status
Korolinska Institutet Department of Hematology
Stockholm, , Sweden
Site Status
University Hospital of Wales, Dept of Haematology
Cardiff, Wales, United Kingdom
Site Status
Leed General Infirmary
Leeds, West Yorkshire, United Kingdom
Site Status
The Royal Bournemouth Hospital
Bournemouth, , United Kingdom
Site Status
Ninewells Hospital and Medical School
Dundee, , United Kingdom
Site Status
Kings College Hospital, Denmark Hill
London, , United Kingdom
Site Status
Central Manchester and Manchester Children's University Hospitals NHS Trust
Manchester, , United Kingdom
Site Status
Nottingham City Hospital
Nottingham, , United Kingdom
Site Status
John Radcliffe Hospital and the Weatherall Institute of Molecular Medicine
Oxford, , United Kingdom
Site Status
Countries
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Belgium
France
Germany
Israel
Italy
Netherlands
Spain
Sweden
United Kingdom
References
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Fenaux, Pierre, Giagounidis, Aristotle, Selleslag, Dominik, Beyne-Rauzy, Odile, Mufti, Ghulam J, Mittelman, Moshe, Muus, Petra, te Boekhorst, Peter, Sanz, Guillermo, del Canizo, Consuelo, Guerci-Bresler, Agnes, Schlegelberger, Brigitte, Aul, Carlo, Kreipe, Hans, Goehring, Gudrun, Knight, Robert, Francis, John, Fu, Tommy, Hellstrom-Lindberg, Eva. RBC Transfusion Independence and Safety Profile of Lenalidomide 5 or 10 mg in Pts with Low- or Int-1-Risk MDS with Del5q: Results From a Randomized Phase III Trial (MDS-004). ASH Annual Meeting Abstracts 2009 114: 944.
Reference Type
RESULT
Fenaux, P., Giagounidis, A., Selleslag, D. L., Beyne-Rauzy, O., Mittelman, M., Muus, P., Knight, R. D., Fu, T., Hellstrom-Lindberg, E., The MDS-004 Len del(5q) Study Group. Safety of lenalidomide (LEN) from a randomized phase III trial (MDS-004) in low-/int-1-risk myelodysplastic syndromes (MDS) with a del(5q) abnormality. J Clin Oncol (Meeting Abstracts) 2010 28: 6598
Reference Type
RESULT
Fenaux, P., Giagounidis, A., Selleslag, D., Knight, R., Fu, T., Hellström-Lindberg, E. Effect of baseline EPO and prior erythropoiesis stimulating agents on RBC transfusion independence in Low-/Int-1-Risk MDS with del 5q treated with lenalidomide: A randomized phase 3 study (MDS-004). Haematologica 2010; 95[suppl.2]:125, abs. 0311.
Reference Type
RESULT
Brandenburg, N., Fu, T., Revicki, D., Knight, R., Muus, P., Fenaux, P. Impact of lenalidomide on health-related quality of life in patients with RBC transfusion-dependent low- or int-1-risk myelodysplastic syndromes with del 5q: a randomized Phase 3 study (MDS-004). Haematologica 2010; 95[suppl.2]:127, abs. 0316
Reference Type
RESULT
Fenaux, P., Giagounidis, A., Beyne-Rauzy, O., Mufti, G., Mittelman, M., Muus, P., te Boekhorst, P., Sanz, G., Cazzola, M., Backstrom, J., Fu, T., Hellström-Lindberg, E. Prognostic Factors of Long-Term Outcomes In Low- or Int-1-Risk MDS with del5q Treated with Lenalidomide (LEN): Results From a Randomized Phase 3 Trial (MDS-004). Blood ASH Annual Meeting Abstracts 2010 116:21 abs. 4027.
Reference Type
RESULT
Brandenburg, N., Yu, R., Revicki, D. Reliability and Validity of the FACT-AN In Patients with Low or Int-1-Risk Myelodysplastic Syndromes with Deletion 5q. Blood ASH Annual Meeting Abstracts 2010 116:21 abs. 3827.
Reference Type
RESULT
Fenaux P, Giagounidis A, Selleslag D, Beyne-Rauzy O, Mittelman M, Muus P, Nimer SD, Hellstrom-Lindberg E, Powell BL, Guerci-Bresler A, Sekeres MA, Deeg HJ, Del Canizo C, Greenberg PL, Shammo JM, Skikne B, Yu X, List AF. Clinical characteristics and outcomes according to age in lenalidomide-treated patients with RBC transfusion-dependent lower-risk MDS and del(5q). J Hematol Oncol. 2017 Jun 26;10(1):131. doi: 10.1186/s13045-017-0491-2.
Reference Type
DERIVED
Saft L, Karimi M, Ghaderi M, Matolcsy A, Mufti GJ, Kulasekararaj A, Gohring G, Giagounidis A, Selleslag D, Muus P, Sanz G, Mittelman M, Bowen D, Porwit A, Fu T, Backstrom J, Fenaux P, MacBeth KJ, Hellstrom-Lindberg E. p53 protein expression independently predicts outcome in patients with lower-risk myelodysplastic syndromes with del(5q). Haematologica. 2014 Jun;99(6):1041-9. doi: 10.3324/haematol.2013.098103. Epub 2014 Mar 28.
Reference Type
DERIVED
Fenaux P, Giagounidis A, Selleslag D, Beyne-Rauzy O, Mufti G, Mittelman M, Muus P, Te Boekhorst P, Sanz G, Del Canizo C, Guerci-Bresler A, Nilsson L, Platzbecker U, Lubbert M, Quesnel B, Cazzola M, Ganser A, Bowen D, Schlegelberger B, Aul C, Knight R, Francis J, Fu T, Hellstrom-Lindberg E; MDS-004 Lenalidomide del5q Study Group. A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with del5q. Blood. 2011 Oct 6;118(14):3765-76. doi: 10.1182/blood-2011-01-330126. Epub 2011 Jul 13.
Reference Type
DERIVED
Gohring G, Giagounidis A, Busche G, Hofmann W, Kreipe HH, Fenaux P, Hellstrom-Lindberg E, Schlegelberger B. Cytogenetic follow-up by karyotyping and fluorescence in situ hybridization: implications for monitoring patients with myelodysplastic syndrome and deletion 5q treated with lenalidomide. Haematologica. 2011 Feb;96(2):319-22. doi: 10.3324/haematol.2010.026658. Epub 2010 Nov 25.
Reference Type
DERIVED
Other Identifiers
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2005-000454-73
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-5013-MDS-004
Identifier Type: -
Identifier Source: org_study_id
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