A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Pomalidomide in Combination With Low-Dose Dexamethasone Versus High-Dose Dexamethasone in Subjects With Refractory Multiple Myeloma or Relapsed and Refractory Multiple Myeloma and Companion Study
NCT ID: NCT01311687
Last Updated: 2018-10-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
455 participants
INTERVENTIONAL
2011-03-11
2017-08-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pomalidomide + Low-Dose Dexamethasone
Participants received 4 mg pomalidomide administered by mouth on Days 1 to 21 of each 28-day treatment cycle and 40 mg dexamethasone (or 20 mg for participants \> 75 years of age) administered by mouth once per day on Days 1, 8, 15, and 22 of each 28-day cycle until disease progression.
pomalidomide
4 mg pomalidomide capsules administered orally
Dexamethasone
40 mg dexamethasone (or 20 mg for participants \> 75 years of age) tablets administered orally
High-Dose Dexamethasone
Participants received 40 mg dexamethasone (or 20 mg for participants \> 75 years of age) administered by mouth once per day on Days 1 to 4, 9 to 12, and 17 to 20 of each 28-day treatment cycle until disease progression.
Dexamethasone
40 mg dexamethasone (or 20 mg for participants \> 75 years of age) tablets administered orally
Interventions
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pomalidomide
4 mg pomalidomide capsules administered orally
Dexamethasone
40 mg dexamethasone (or 20 mg for participants \> 75 years of age) tablets administered orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects must have documented diagnosis of multiple myeloma and have measurable disease
* Subjects must have undergone prior treatment with ≥ 2 treatment lines of anti-myeloma therapy
* Subjects must have either refractory or relapsed and refractory disease defined as documented disease progression during or within 60 days of completing their last myeloma therapy
* All subjects must have received at least 2 consecutive cycles of prior treatment that included lenalidomide and bortezomib
* All subjects must have failed treatment with both lenalidomide and bortezomib in one of the following ways: 1) Documented progressive disease on or within 60 days of completing treatment with lenalidomide and/or bortezomib, or 2) In case of prior response \[≥ partial response (PR)\] to lenalidomide or bortezomib, subjects must have relapsed within 6 months after stopping treatment with lenalidomide and/or bortezomib-containing regimens, or 3) Subjects who have not had a ≥ minimal response (MR) and have developed intolerance/toxicity after a minimum of two cycles of lenalidomide- and/or bortezomib-containing regimen
* Patients must have received adequate prior alkylator therapy
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* Females of childbearing potential (FCBP) must not become pregnant for 28 days prior to initiation of study drug, during the study, and for 28 days after discontinuation
* Females must agree to abstain from breastfeeding during study participation and 28 days after study drug discontinuation
* Males must agree to use a latex condom during any sexual during the study and for 28 days following discontinuation from this study
* Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this study
Exclusion Criteria
* Absolute neutrophil count (ANC) \< 1,000/μL
* Platelet count \< 75,000/ μL for subjects in whom \< 50% of bone marrow nucleated cells are plasma cells
* Creatinine clearance \< 45 mL/min
* Corrected serum calcium \> 14 mg/dL
* Hemoglobin ≤ 8 g/dL
* Serum glutamic oxaloacetic transaminase (SGOT)/ aspartate aminotransferase (AST) or transaminase, serum glutamic pyruvic (SGPT)/ alanine aminotransferase (ALT) \> 3.0 x upper limit of normal (ULN)
* Serum total bilirubin \> 2.0 mg/dL
* Previous therapy with pomalidomide
* Hypersensitivity to thalidomide, lenalidomide, or dexamethasone
* Resistance to high-dose dexamethasone used in the last line of therapy
* Peripheral neuropathy ≥ Grade 2
* Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant
* Subjects who are planning for or who are eligible for stem cell transplant
* Subjects with any one of the following: 1) Congestive heart failure, 2) Myocardial infarction within 12 months prior to starting study treatment, 3) Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris
* Subjects who received any of the following within the last 14 days of initiation of study treatment: 1) Plasmapheresis, 2) Major surgery, 3) Radiation therapy, 4) Use of any anti-myeloma drug therapy
* Use of any investigational agents within 28 days or 5 half-lives (whichever is longer) of treatment
* Subjects with conditions requiring chronic steroid or immunosuppressive treatment
* Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
* Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide
* Subjects unable or unwilling to undergo antithrombotic prophylactic treatment
* Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subjects from signing the informed consent form
* Pregnant or breastfeeding females
* Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis A, B, or C
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Lars Sternas, MD, PhD
Role: STUDY_DIRECTOR
Celgene
Locations
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Mayo Clinic
Rochester, Minnesota, United States
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Peter MacCallum Cancer Institute
East Melbourne, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Princess Alexandra Hospital
Brisbane, , Australia
Royal Prince Alfred Hospital
Camperdown, , Australia
Alfred hospital
Melbourne, , Australia
Sir Charles Gairdner Hospital
Nedlands, , Australia
Calvary Mater Hospital
Waratah, , Australia
Border Medical Oncology
Wodonga, , Australia
Wollongong Hospital
Wollongong, , Australia
UZ Gent
Ghent, , Belgium
UZ Leuven
Leuven, , Belgium
CHU UCL Mont-Godinne-Dinant asbl
Yvoir, , Belgium
Tom Baker Cancer Center
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
James Cancer Hospital
Halifax, Nova Scotia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Health Sciences Centre
London, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Maisonneuve Rosemont
Montreal, Quebec, Canada
Royal Victoria Hospital McGill Department of Oncology(RVH)
Montreal, Quebec, Canada
Sir Mortimer B. Davis - Jewish Genl
Montreal, Quebec, Canada
Charles University General Hospital
Prague, , Czechia
Hæmatologisk afd. B Aalborg Sygehus Syd
Aalborg, , Denmark
Aarhus University Hospital
Arhus C, , Denmark
Odense Universitetshospital
Odense C, , Denmark
Vejle Hospital
Vejle, , Denmark
CHU d'Angers
Angers, , France
Centre Hospitalier de la cote basque
Bayonne, , France
Centre Hospitalier Departemental
La Roche-sur-Yon, , France
CHRU de Lille FR
Lille, , France
Institut Paoli-Calmettes
Marseille, , France
CHRU Nantes
Nantes, , France
Hopital Saint-Louis
Paris, , France
CHU Hôpital St-Antoine
Paris, , France
CHRU - Hopital du Haut Leveque
Pessac, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Hopital Bretonneau
Tours, , France
Hopital Purpan
Tulouse Cedex 9, , France
CHU Nancy
Vandœuvre-lès-Nancy, , France
Universitatsklinikum Carl Gustav Carus
Dresden, , Germany
Universitatsklinikum Essen
Essen, , Germany
Askepios Klinik St. Georg
Hamburg, , Germany
Universitatsklinikum Heidelberg
Heidelberg, , Germany
Universitatsklinikum Jena
Jena, , Germany
Universitatsklinikum Leipzig
Leipzig, , Germany
University of Tubingen
Tübingen, , Germany
Universitatsklinikum Ulm
Ulm, , Germany
Universitatsklinikum Wurzburg
Würzburg, , Germany
Alexandra General Hospital of Athens
Athens, , Greece
Azienda Ospedaliero-Universitaria di Bologna - Policlinico S.Orsola-Malpighi
Bologna, , Italy
Clinica Ematologica- A.O.U. San Martino
Genova, , Italy
Oncoematologia, Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, , Italy
AOU San Luigi Gonzaga
Orbassano, , Italy
Universita degli Studi di Padova
Padua, , Italy
Hospital Clinic
Placenza, , Italy
Servizio di Ematologia, A.O. - Arcispedale S.Maria Nuova
Reggio Emilia, , Italy
Univerita La Sapienza Dipartimento di Biotecnologie Cellulari ed Ematologia
Rome, , Italy
Azienda Ospedaliera San Giovanni Battista
Torino, , Italy
VU University Medical Center
Amsterdam, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
State Institution Hematological Research, Centre of Russian Academy of Medical Science
Moscow, , Russia
State Institution Moscow Regional Research Clinical Institute
Moscow, , Russia
St. Petersburg Research Institute of Hematology and Blood Transfusion
Saint Petersburg, , Russia
State Educational Institution, Saint Petersburg State Medical University
Saint Petersburg, , Russia
Hospital Universitari Germans Trias i Pujol
Badalona (Barcelona), , Spain
Hospital Clinic Provincial de Barcelona
Barcelona, , Spain
Hospital de La Princesa
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Universitario de Salamanca
Salamanca, , Spain
Hospital Donostia
San Sebastián (Guipuzcoa), , Spain
Hospital Universitario Marques de Valdecilla
Santander, , Spain
Hospital de la Fe
Valencia, , Spain
Department of Hematology Hematology Centre
Gothenburg, , Sweden
University Hospital in Lund
Lund, , Sweden
Karolinska University Hospital Huddinge
Stockholm, , Sweden
Karolinska University Hospital
Stockholm, , Sweden
Overlakare Medocomcentrum, hematologi
Uppsala, , Sweden
Medizinische Universitatsklinik
Bern, , Switzerland
Hopitaux Universitaires de Geneve-HUG
Geneva, , Switzerland
UniversitatSspital Zurich
Zurich, , Switzerland
Royal Bournemouth Hospital
Bournemouth, , United Kingdom
St James's University Hospital
Leeds, , United Kingdom
St.Bartholomew's Hospital
London, , United Kingdom
King's College Hospital
London, , United Kingdom
Freeman Hospital
Newcastle upon Tyne, , United Kingdom
Nottingham City Hospital
Nottingham, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Royal Hallamshire HospitalSheffield Teaching Hospitals NHS Trust
Sheffield, , United Kingdom
The Royal Marsden Hospital
Sutton-Surrey, , United Kingdom
The Royal Wolverhampton Hospital NHS Trust
Wolverhampton, , United Kingdom
Countries
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References
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Moreau P, Weisel KC, Song KW, Gibson CJ, Saunders O, Sternas LA, Hong K, Zaki MH, Dimopoulos MA. Relationship of response and survival in patients with relapsed and refractory multiple myeloma treated with pomalidomide plus low-dose dexamethasone in the MM-003 trial randomized phase III trial (NIMBUS). Leuk Lymphoma. 2016 Dec;57(12):2839-2847. doi: 10.1080/10428194.2016.1180685. Epub 2016 May 13.
Miguel JS, Weisel K, Moreau P, Lacy M, Song K, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Belch A, Palumbo A, Schey S, Sonneveld P, Yu X, Sternas L, Jacques C, Zaki M, Dimopoulos M. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013 Oct;14(11):1055-1066. doi: 10.1016/S1470-2045(13)70380-2. Epub 2013 Sep 3.
Siegel DS, Weisel KC, Dimopoulos MA, Baz R, Richardson P, Delforge M, Song KW, San Miguel JF, Moreau P, Goldschmidt H, Cavo M, Jagannath S, Yu X, Hong K, Sternas L, Zaki M, Palumbo A. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016 Dec;57(12):2833-2838. doi: 10.1080/10428194.2016.1177181. Epub 2016 Jun 7.
Weisel KC, Dimopoulos MA, Moreau P, Lacy MQ, Song KW, Delforge M, Karlin L, Goldschmidt H, Banos A, Oriol A, Alegre A, Chen C, Cavo M, Garderet L, Ivanova V, Martinez-Lopez J, Knop S, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, San Miguel J. Analysis of renal impairment in MM-003, a phase III study of pomalidomide + low - dose dexamethasone versus high - dose dexamethasone in refractory or relapsed and refractory multiple myeloma. Haematologica. 2016 Jul;101(7):872-8. doi: 10.3324/haematol.2015.137083. Epub 2016 Apr 14.
Dimopoulos MA, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Spencer A, Knop S, Bahlis NJ, Renner C, Yu X, Hong K, Sternas L, Jacques C, Zaki MH, San Miguel JF. Cytogenetics and long-term survival of patients with refractory or relapsed and refractory multiple myeloma treated with pomalidomide and low-dose dexamethasone. Haematologica. 2015 Oct;100(10):1327-33. doi: 10.3324/haematol.2014.117077. Epub 2015 Aug 6.
San Miguel JF, Weisel KC, Song KW, Delforge M, Karlin L, Goldschmidt H, Moreau P, Banos A, Oriol A, Garderet L, Cavo M, Ivanova V, Alegre A, Martinez-Lopez J, Chen C, Renner C, Bahlis NJ, Yu X, Teasdale T, Sternas L, Jacques C, Zaki MH, Dimopoulos MA. Impact of prior treatment and depth of response on survival in MM-003, a randomized phase 3 study comparing pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed/refractory multiple myeloma. Haematologica. 2015 Oct;100(10):1334-9. doi: 10.3324/haematol.2015.125864. Epub 2015 Jul 9.
Weisel K, Dimopoulos M, Song KW, Moreau P, Palumbo A, Belch A, Schey S, Sonneveld P, Sternas L, Yu X, Amatya R, Gibson CJ, Zaki M, Jacques C, San Miguel J. Pomalidomide and Low-Dose Dexamethasone Improves Health-Related Quality of Life and Prolongs Time to Worsening in Relapsed/Refractory Patients With Multiple Myeloma Enrolled in the MM-003 Randomized Phase III Trial. Clin Lymphoma Myeloma Leuk. 2015 Sep;15(9):519-30. doi: 10.1016/j.clml.2015.05.007. Epub 2015 Jun 6.
Song KW, Dimopoulos MA, Weisel KC, Moreau P, Palumbo A, Belch A, Schey S, Sonneveld P, Sternas L, Yu X, Amatya R, Monzini MS, Zaki M, Jacques C, San Miguel J. Health-related quality of life from the MM-003 trial of pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone in relapsed and/or refractory multiple myeloma. Haematologica. 2015 Feb;100(2):e63-7. doi: 10.3324/haematol.2014.112557. Epub 2014 Nov 25. No abstract available.
Other Identifiers
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2010-019820-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CC-4047-MM-003
Identifier Type: -
Identifier Source: org_study_id
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