A Study of Lenalidomide Versus Placebo in Subjects With Transfusion Dependent Anemia in Low Risk Myelodysplastic Syndrome (MDS) Without Del 5Q (MDS-005)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT01029262
First received: December 8, 2009
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to investigate whether lenalidomide would reduce the number of red blood cell transfusions needed by anemic (RBC transfusion-dependent) subjects with low or intermediate-1 risk MDS without a deletion 5q chromosome abnormality. The study will also investigate the safety of lenalidomide use in these subjects. Two-thirds of the subjects will receive lenalidomide and one-third of the subjects will receive placebo (does not contain lenalidomide).


Condition Intervention Phase
Anemia
Drug: Lenalidomide
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Placebo-Controlled Study to Compare the Efficacy and Safety of Lenalidomide vs. Placebo in Subjects With Transfusion Dependent Anemia Due to Low or Intermediate Risk MDS and Unresponsive to ESA Therapies

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • Proportion of subjects that become transfusion independent. Proportion of subjects with an erythroid differentiation gene expression signature that become transfusion independent. [ Time Frame: Up to 4 years for each subject (likely to be 6 months to 2 years) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the safety of lenalidomide versus placebo. [ Time Frame: up to 6 years from study start through follow-up ] [ Designated as safety issue: Yes ]
  • Evaluate the impact of lenalidomide therapy on health-related quality of life (HRQOL) and use of healthcare resources. [ Time Frame: up to 6 years from study start through follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 228
Study Start Date: November 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm #1 - Lenalidomide
10 mg lenalidomide once daily (administered as one 10-mg lenalidomide capsule + 2 placebo capsules)
Drug: Lenalidomide

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)

Other Name: Revlimid
Placebo Comparator: Arm #2 - placebo
Three placebo capsules once daily. Subjects will be randomized using a 2:1 ratio in a double-blind manner to receive oral lenalidomide 10 mg once daily or placebo once daily. Subjects will receive oral lenalidomide 10 mg once daily (one 10 mg lenalidomide capsules + 2 placebo capsule) or matching placebo once daily (3 placebo capsules).
Other: 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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • Diagnosis of low or intermediate-1 risk 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
  • ECOG Performance Status ≤ 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 DNA modulation agents
  • Allergic reaction to thalidomide
  • Renal insufficiency (CrC1<40 mL/min by Cockroft-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 T1a or T1b prostate cancer is allowed)
  • Absolute neutrophil count < 500/uL
  • Platelets < 50,000/uL
  • AST or 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 HIV infection; known Hepatitis C infection or active Hepatitis B infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01029262

  Hide Study Locations
Locations
Australia, Queensland
(004) Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Austria
(151) Medizinische Universitat Innsbruck
Innsbruck, Tyrol, Austria, 6020
(152) Wiener Gebietskrankenkasse-Hanusch-Krankenhaus
Wien, Vienna, Austria, 1140
(153) Krankenhaus der Elisabethinen Linz, Interne Abteilung
Linz, Austria, 4020
(154) Universitätsklinik für Innere Medizin Salzburg
Salzburg, Austria, 5020
(155) Klinikum Wels-Grieskirchen GmbH
Wels, Austria, 4600
Belgium
(207) Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Namur, Belgium, 5530
(203) Algemeen Ziekenhuis Sint-Jan
Brugge, West-Vlaanderen, Belgium, 8000
(206) Cliniques Universitaires Saint Luc
Brussels, Belgium, 1200
(205) Grand Hôpital de Charleroi
Charleroi, Belgium, 6000
Canada, Alberta
(804) University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
(806) Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada, M4N 3M5
(801) Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Czech Republic
(252) Fakultni nemocnice Olomouc, hemato-onkologicka klinika
Olomouc, Czech Republic, 77920
(254) Ustav Hematologie a Krevni Transfuze
Praha, Czech Republic, 2 128 20
(253) Vseobecna Fakultni Nemocnice v Praze
Praha, Czech Republic, 2 1280 08
France
(304) Hôpital Avicenne - Service d'Hématologie Clinique
Bobigny, France, 93009
(303) Hopital A. Michallon
La Tronche, France, 38700
(305) Hôpital Claude Hurlezk service des maladies du sang
Lille Cedex, France, 59037
(306) Institut Paoli Calmettes Centre Regional de Lutte Contre le Cancer
Marseille, France, Cedex 09 13273
Germany
(357) Universitat Heidelberg
Heidelberg, Baden-Wuerttemberg, Germany, 69120
(353) Universitatsklinikum Mannheim
Mannheim, Baden-Wuerttemberg, Germany, 68167
(355) Klinikum rechts der Isar, Technische Universitat Munchen
Munchen, Bayern, Germany, 81675
(352) Sankt Johannes Hospital Duisburg
Duisburg, Nordrhein-Westfalen, Germany, 47166
(356) Universitätsklinikum Düsseldorf, Klinik für Hämatologie, Onkologie und Klinische Immunologie
Düsseldorf, Nordrhein-Westfalen, Germany, 40211
(359) Gemeinschaftspraxis fur Hamatologie un Onkologie
Dresden, Germany, 01307
(360) Marien Hospital Dusseldorf
Dusseldorf, Germany, 47166
Israel
(404) Rabin Medical Center
Petach Tikva, Israel, 49100
(401) Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
(402) Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Italy
(455) IRCCS Centro di Riferimento Oncologico di Basilicata di Rionero in Vulture
Rionero in Vulture, Potenza, Italy, 85028
(456) Azienda Ospedaliera SS. Antonio E. Biagio E. Cesare Arrigo di Allessandria
Alessandria, Italy, 15100
(460) Instituto Di Ematologia ED Oncologia Medica "LA Seragnoli" Policlinico S. Orsola Malpighi
Bologna, Italy, 40138
(461) Ospedale R. Binaghi
Cagliari, Italy, 09100
(462) Azienda Ospedalieo - Universitaria Careggi
Firenze, Italy, 50139
(452) Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma, Italy, 00133
(463) Universita Cattolica Sacro Cuore
Roma, Italy, 00168
(453) Azienda Policlinico Umberto l di Roma
Roma, Italy, 00161
(451) Azienda Ospedaliero Universitaria "S. Maria della Misericordia" di Udine
Udine, Italy, 33100
Japan
(906) National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, Japan, 460-0001
(910) Kameda General Hospital
Kamogawa, Chiba, Japan, 296-8602
(911) Tohoku University Hospital
Sendai, Fukushima, Japan, 980-8574
(904) Tokai University School of Medicine
Isehara, Kanagawa, Japan, 259-1193
(901) Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan, 329-0498
(902) Japanese Red Cross Medical Center
Shibuya, Tokyo, Japan, 150-8935
(903) Kanto Medical Center NTT EC
Shinagawa, Tokyo, Japan, 141-8625
(908) Hiroshima University Hospital
Hiroshima, Japan, 734-8551
(907) Osaka Red Cross Hospital
Osaka, Japan, 543-6555
Poland
(504) Katedra I Klinika Hematologii z Osrodkiem Transplantacji Szpiku Kostnego AM; SPSK nr 1
Gdansk, Pomorskie, Poland, 80-952
(503) Instytut Hematologii i Tansfuzjologii, Klinika Hematologii
Warsaw, Poland, 02-776
Portugal
(553) Hospitais da Universidade de Coimbra
Coimbra, Portugal, 3000-076
(552) Instituto Português de Oncologia de Lisboa de Francisco Gentil, EPE
Lisboa, Portugal, 1090-023
Spain
(602) Hospital Son Llatzer
Palma de Mallorca, Baleares, Spain, 7198
(607) Hospital Clinic i Provincial - Servicio de Hematologia y Hemoterapia
Barcelona, Spain, 8036
(606) Hospital Universitario La Paz
Madrid, Spain, 28046
(603) Hospital Clinico Universitario Virgen de la Victoria
Malaga, Spain, 29010
(605) Hospital Universitario de Salamanca, Hospital Clinico, Sevicio de Hematologia
Salamanca, Spain, 37007
(608) Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
(601) Hospital La Fe, Servicio de Hematologia
Valencia, Spain, 46009
Turkey
(654) Gazi Universitesi Tip Fakultesi
Ankara, Turkey, 06500
(652) Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, Turkey, 34390
United Kingdom
(707) Royal Bournemouth Hospital
Bournemouth, England, United Kingdom, BH7 7DW
(704) Saint James' University Hospital
Leeds, England, United Kingdom, LS1 3EX
(702) King's College Hospital
London, England, United Kingdom, SE5 9RS
(701) Christie Hospital
Manchester, England, United Kingdom, M20 4BX
(705) John Radcliffe Hospital
Oxford, England, United Kingdom, 0X3 9DS
(706) University Hospital of Wales
Cardiff, Wales, United Kingdom, CF1F 4XW
Sponsors and Collaborators
Celgene Corporation
Investigators
Study Director: Bouchra Benettaib, MD Celgene Corporation
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT01029262     History of Changes
Other Study ID Numbers: CC-5013-MDS-005
Study First Received: December 8, 2009
Last Updated: July 8, 2013
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Federal Office for Safety in Health Care
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Israel: Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Italy: The Italian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Portugal: National Pharmacy and Medicines Institute
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Celgene Corporation:
Myelodysplastic Syndromes
MDS
transfusion dependent anemia
Erythropoiesis stimulating agents
non-del 5q

Additional relevant MeSH terms:
Anemia
Myelodysplastic Syndromes
Preleukemia
Hematologic Diseases
Bone Marrow Diseases
Precancerous Conditions
Neoplasms
Lenalidomide
Thalidomide
Hematinics
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on July 24, 2014