Study to Evaluate the Safety and Efficacy of Pomalidomide Monotherapy in Subjects With Refractory or Relapsed Refractory Multiple Myeloma

Open-label, Multi-center, Single Arm Study For The Safety And Efficacy Of Pomalidomide Monotherapy For Subjects With Refractory Or Relapsed And Refractory Multiple Myeloma. A Companion Study For Clinical Trial CC-4047-MM003

The purpose of this study is to evaluate the efficacy and safety of pomalidomide monotherapy in subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in study CC-4047-MM-003 (NCT01311687) and discontinued treatment with high-dose dexamethasone due to disease progression.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: pomalidomide

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Royal Adelaide Hospital - SA Pathology Haematology
  • Brisbane, Australia, 4102
    • Princess Alexandra Hospital - Haematology
  • Camperdown, Australia, 2050
    • Royal Prince Alfred Hospital - Institute of Haematology
  • East Melbourne, Australia, 3002
    • Peter McCallum Cancer Institute - Directorate of Cancer Medicine
  • Frankston, Australia, 3199
    • Frankston Hospital-Peninsula Health - Oncology Day Unit
  • Melbourne, Australia, 3004
    • The Alfred Hospital - Malignant Haematology & Stem Cell Transplantation
  • Waratah, Australia, 2298
    • Calvary Mater Newcastle - Haematology
  • Wodonga, Australia, 3690
    • Border Medical Oncology
  • Wollongong, Australia, 2500
    • Wollongong Hospital - Haematology
• Belgium
  • Gent, Belgium, 9000
    • UZ Gent - Hematology
  • Leuven, Belgium, 3000
    • University Hospital Leuven - Hematology
  • Yvoir, Belgium, 5530
    • Cliniques Universitaires ULC de Mont-Godinne - Hematology
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N2
      • Tom Baker Cancer Center
    • Edmonton, Alberta, Canada, T6G 1Z2
      • Cross Cancer Institute
  • British Columbia
    • Vancouver, British Columbia, Canada, V5Z 1M9
      • British Columbia Cancer Agency, Vancouver Centre
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 2Y9
      • Queen Elizabeth II Health Sciences Centre
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital, University Health Network
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Maisonneuve-Rosemont Hospital
    • Montreal, Quebec, Canada, H3A1 A1
      • Royal Victoria Hospital
• Czechia
  • Prague, Czechia, 12808
    • Charles University Hospital - Internal Medicine
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Sygemus - Haematology
  • Aarhus, Denmark, 8000
    • Aarhus University Hospital
  • Odense, Denmark, 5000
    • Odense University Hospital
  • Vejle, Denmark, 7100
    • Vejle Hospital - Hematology
• France
  • Angers, France, 49033
    • CHU Angers - Service des maladies du sang
  • Bayonne, France, 64019
    • Centre Hospitalier de la côte basque - Hematologie
  • La Roche, France, 85925
    • Centre Hospitalier Départemental Vendée - Onco-hematologie
  • Lille, France, 59037
    • CHRU de Lille - Service des maladies du sang
  • Marseille, France, 13009
    • Institut Paoli Calmette - Hematology 1
  • Nantes, France, 44093
    • CHU Hôtel-Dieu - Hematologie
  • Paris, France, 75010
    • Hôpital Saint Louis - Immuno-hematologie
  • Paris, France, 75012
    • CHU Saint Antoine - Service des maladies du sang
  • Pessac, France, 33604
    • CHRU - Hôpital du Haut Lévêque - Centre François Magendie Service des maladies du sang
  • Pierre-Benite, France, 69495
    • Centre Hospitalier Lyon Sud - Hématologie
  • Toulouse, France, 31059
    • CHRU Hôpital Purpan - Hematologie
  • Tours, France, 37044
    • Hôpital Bretonneau - Hématologie & Thérapie cellulaire
  • Vandoeuvre-les-Nancy, France, 54511
    • CHU Nancy - Hematologie
• Germany
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carus-Medizinische Klinik und Poliklinik I
  • Essen, Germany, 45122
    • Universitätsklinikum Essen, Klinik für Hämatologie Westdeutsches Tumorzentrum
  • Hamburg, Germany, 22763
    • Askepios Klinik Altona-Abteilung Hamatologie und Internistische Onkologie
  • Heidelberg, Germany, 69120
    • Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V
  • Jena, Germany, 07740
    • Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie
  • Leipzig, Germany, 04103
    • Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II
  • Münster, Germany, 48149
    • Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A
  • Tübingen, Germany, 72076
    • Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm - Klinik fur Innere Medizin III
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II
• Greece
  • Athens, Greece, 14572
    • University of Athens - Alexandra Hospital
• Italy
  • Bologna, Italy, 40138
    • Università degli Studi di Bologna - Policlinico S. Orsola - Hematology
  • Genova, Italy, 16132
    • AO Universitaria San Martino - hematooncology
  • Napoli, Italy, 80131
    • Fondazione "G. Pascale" - Hematology
  • Orbassano, Italy, 10043
    • Ospedale San Luigi AO Luigi Gonzaga - Hematology
  • Padova, Italy, 35128
    • Universita degli Studi di Padova - Clinical & Experimental Medicine
  • Piacenza, Italy, 29100
    • Ospedale Guglielmo da Saliceto - hematooncology
  • Reggio Emilia, Italy, 42100
    • Unità di Ematologia Arcispedale S. Maria Nuova - Haematology
  • Roma, Italy, 00161
    • Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology
  • Torino, Italy, 10126
    • A.O.U. San Giovanni Battista - Hematology
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VUMC - Hematology
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medical Center - Hematology
  • Utrecht, Netherlands, 3584 CX
    • University Medical Center - Hematology
• Russian Federation
  • Moscow, Russian Federation, 125284
    • Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology
  • Moscow, Russian Federation, 125167
    • Hematological Research Center under the Russian Academy of Medical Sciences - Hematology & BMT
  • St. Petersburg, Russian Federation, 191024
    • Russian Research Institute of Hematology and Blood Transfusion - Hematology
  • St. Petersburg, Russian Federation, 197341
    • State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology
• Spain
  • Badalona, Spain, 08916
    • Hospital Germans Trias i Pujol - Hematology
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona - Hematology
  • Guipúzcoa, Spain, 20014
    • Hospital de Donostia - Hematology
  • Madrid, Spain, 28006
    • Hospital de La Princesa - Hematology
  • Madrid, Spain, 28041
    • Hospital 12 de Octubre - Hematology
  • Salamanca, Spain, 37007
    • Hospital de Salamanca - Hematology
  • Santander, Spain, 39008
    • Hospital Universitario Marqués de Valdecilla - Hematology
  • Valencia, Spain, 46009
    • Hospital La Fe - Hematology
• Sweden
  • Goteborg, Sweden, S-41345
    • Sahlgrenska Hospital, University of Goteborg - Hematology
  • Stockholm, Sweden, 14152
    • Karolinska University Hospital Huddinge - Center of hematology
  • Stockholm, Sweden, 17176
    • Karolinska University Hospital Solna- medicine
  • Stockholm, Sweden, 14186
    • Karolinska University Hospital-medicine
  • Uppsala, Sweden, 75185
    • Overlakare Medocomcentrum - Hematology
• Switzerland
  • Bern, Switzerland, 3010
    • Inselspital, Institut für Medizinische Onkologie
  • Genève, Switzerland, 1211
    • Hôpitaux Universitaire de Genève - Oncologie
  • Zürich, Switzerland, 8091
    • Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich
• United Kingdom
  • Bournemouth, United Kingdom, BH7 7DW
    • Royal Bournemouth Hospital - Haematology
  • Leeds, United Kingdom, LS9 7TF
    • St James's University Hospital - Haematology
  • London, United Kingdom, EC1A 7BE
    • St Bartholomew's Hospital - Medical Oncology
  • London, United Kingdom, SE5 9RS
    • King's College Hospital - Haematology Clinical Trials
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Freeman Hospital - Northern Centre for Cancer Care
  • Nottingham, United Kingdom, NG5 1PB
    • Nottingham City Hospital - Centre for Clinical Haematology
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital - Haematology
  • Sheffield, United Kingdom, S10 2JF
    • Royal hallamshire Hospital - Haematology
  • Surrey, United Kingdom, SM2 5PT
    • Royal Marsden NHS Foundation Trust - Haematology
  • Wolverhampton, United Kingdom, WV10 OQP
    • Royal Wolverhampton Hospitals Trust - Research and Development

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Subjects with refractory or relapsed and refractory multiple myeloma who were enrolled in Study CC-4047-MM-003 and discontinued study therapy with dexamethasone alone (Treatment Arm B) after at least starting the second cycle of dexamethasone treatment and due to development of documented disease progression according to the International Myeloma Working Group (IMWG) criteria and as decided by an Independent Review Adjudication Committee (IRAC).
2. Must be ≥ 18 years at the time of signing the informed consent form.
3. The subject must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted. The only exception is if a skeletal survey was performed within 90 days prior to the start of Cycle 1, then a new survey will not be required.
4. Must be able to adhere to the study visit schedule and other protocol requirements.
5. Subjects must have documented diagnosis of multiple myeloma and have measurable disease (serum M-protein ≥ 0.5g/dL or urine M-protein ≥ 200 mg/24 hours).
6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
7. Females of childbearing potential (FCBP†) must agree to utilize two reliable forms of contraception simultaneously or practice true abstinence [when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post ovulation methods) and withdrawal are not acceptable methods of contraception]from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe.
8. Females must agree to abstain from breastfeeding during study participation and 28 days after study discontinuation.
9. Males must agree to either use a latex condom during any sexual contact with FCBP or practice true abstinence [when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception] while participating in the study and for 28 days following discontinuation from this study, even if he has undergone a successful vasectomy. .
10. Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this study treatment.
11. All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.
12. All subjects must agree not to share study medication

Exclusion Criteria

• The presence of any of the following will exclude a subject from enrollment:

  1. Subjects with multiple myeloma who were not treated as a part of Study CC-4047-MM-003 (Arm B).
  2. Subjects who received any anti-myeloma or anti-cancer therapies within the last 14 days of wash-out period before initiation of study treatment.
  3. Subjects who discontinued CC-4047-MM-003 study ≥120 days.
  4. Subjects who initiate another anti-myeloma therapy from the time of disease progression on study CC-4047-MM-003 to the time of treatment initiation in the companion study.

  5. Any of the following laboratory abnormalities:

     • 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; or a platelet count < 30,000/µL for subjects in whom ≥ 50% of bone marrow nucleated cells are plasma cells
     • Creatinine Clearance < 45 mL/min according to Cockcroft-Gault formula (If creatinine clearance calculated from the 24-hour urine sample is ≥45 ml/min, patient will qualify for the trial)
     • Corrected serum calcium > 14 mg/dL (> 3.5 mmol/L);
     • Hemoglobin < 8 g/dL (< 4.9 mmol/L; prior RBC transfusion or recombinant human erythropoietin use is permitted)
     • Serum SGOT/AST or SGPT/ALT > 3.0 x upper limit of normal (ULN)
     • Serum total bilirubin > 2.0 mg/dL (34.2 μmol/L); or > 3.0 x ULN for subjects with hereditary benign hyperbilirubinaemia

  6. Prior history of malignancies, other than Multiple Myeloma (MM), unless the subject has been free of the disease for ≥ 5 years. Exceptions include the following:

     • Basal or Squamous cell carcinoma of the skin
     • Carcinoma in situ of the cervix or breast
     • Incidental histologic finding of prostate cancer (TNM stage of T1a or T1b)
  7. Hypersensitivity to thalidomide or lenalidomide. (This includes ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy).
  8. Peripheral neuropathy ≥ Grade 2.
  9. Subjects who received an allogeneic bone marrow or allogeneic peripheral blood stem cell transplant less than 12 months prior to initiation of study treatment and who have not discontinued immunosuppressive treatment for at least 4 weeks prior to initiation of study treatment and are currently dependent on such treatment.
  10. Subjects who are planning for or who are eligible for stem cell transplant.

  11. Subjects with any one of the following:

      • Congestive heart failure (NY Heart Association Class III or IV)
      • Myocardial infarction within 12 months prior to starting study treatment
      • Unstable or poorly controlled angina pectoris, including Prinzmetal variant angina pectoris

  12. Subjects who received any of the following within the last 14 days of initiation of study treatment:

      • Plasmapheresis
      • Major surgery (kyphoplasty is not considered major surgery)
      • Radiation therapy
  13. Use of any investigational agents within 28 days or 5 half lives (whichever is longer) of treatment.
  14. Subjects with chronic conditions such as rheumatoid arthritis, multiple sclerosis and lupus, which likely need additional steroid or immunosuppressive treatments in addition to the study treatment.
  15. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.
  16. Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide.
  17. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment.
  18. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.
  19. Pregnant or breastfeeding females.
  20. Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis A, B or C.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pomalidomide; Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity	Drug: pomalidomide; Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity; Other Names: CC-4047

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With an Objective Response According to International Myeloma Working Group (IMWG) Uniform Response Criteria Based on Investigator Assessment	Objective response defined as a best overall response of stringent complete response (SCR), complete response (CR), very good partial response (VGPR) or partial response (PR) based on Investigator Assessment. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. A ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas.	From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Objective Response According to European Group for Blood and Marrow Transplantation (EBMT) Criteria Based on Investigator Assessment	Objective response defined as a best overall response of complete response (CR) or partial response (PR) based on the CR and requires all of the following: Absence of original monoclonal paraprotein in serum and urine by immunofixation maintained at least 42 days.; <5% plasma cell in bone marrow aspirate and on bone marrow biopsy, if performed.; No increase in size or number of lytic bone lesions.; Disappearance of soft tissue plasmacytomas. PR requires all of the following: ≥50% reduction in level of serum monoclonal paraprotein, maintained at least 42 days.; Reduction in 24-hour urinary light chain extraction by ≥90% or to <200 mg, maintained at least 42 days.; For patients with non-secretory myeloma, ≥50% reduction in plasma cells in bone marrow aspirate and on biopsy, if performed, for at least 42 days.	From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum time on follow-up was 141.1 weeks.
Number of Participants With Adverse Events and Type of Adverse Events	An adverse event is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. A serious AE is any AE occurring at any dose that: Results in death;; Is life-threatening;; Requires or prolongs existing inpatient hospitalization;; Results in persistent or significant disability/incapacity;; Is a congenital anomaly/birth defect;; Constitutes an important medical event. The Investigator assessed the relationship of each AE to study drug and graded the severity according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required);-Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death	From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 31 July 2014. Maximum time on treatment was 94.1 weeks.
Kaplan Meier Estimates for Progression Free Survival (PFS) by Investigator Based on IMWG	Progression-free survival was calculated as the time from randomization to disease progression as determined by the Investigator based on the International Myeloma Working Group Uniform Response criteria (IMWG), or death on study, whichever occurred earlier. Progressive disease requires 1 of the following: Increase of ≥ 25% from nadir in:Serum M-component (absolute increase ≥ 0.5 g/dl)Urine M-component (absolute increase ≥ 200 mg/24 hours)In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)Bone marrow plasma cell percentage (absolute % ≥ 10%); Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.	From randomization through the follow-up phase; Maximum duration of follow-up for PFS was 90.3 weeks.
Kaplan-Meier Estimate for Time to Progression (TTP) Based on Investigator Assessment Using IMWG Criteria	Time to progression (TTP) was calculated as the time from randomization to the first documented progression confirmed by the investigator and based on the International Myeloma Working Group Uniform Response criteria (IMWG). Progressive disease requires 1 of the following: Increase of ≥ 25% from nadir in:Serum M-component (absolute increase ≥ 0.5 g/dl)Urine M-component (absolute increase ≥ 200 mg/24 hours)In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/dl)Bone marrow plasma cell percentage (absolute % ≥ 10%); Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas.; Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease.	From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to progression follow-up was 90.3 weeks.
Kaplan-Meier Estimate Duration of Response Based on Investigator Assessment Using IMWG Criteria	Duration of Response (calculated for responders only) is defined as the time from the initial documented response (partial response or better) to confirmed disease progression by the investigator based on IMWG criteria.	From randomization through the study follow-up phase; up to the data cut-off of 31 July 2014; Maximum duration of response follow-up was 90.3 weeks.
Kaplan-Meier Estimate for Overall Survival	Overall survival was calculated as the time from randomization to death from any cause. Overall survival was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented.	From randomization through the follow-up phase; Maximum time on follow-up was 141.1 weeks.
Time to Response Based on IMWG and Assessed by the Investigator	Time to Response was calculated as the time from enrollment to the initial response (PR or better) based on IMWG and assessed by the investigator.	From randomization through the follow-up phase; up to the data-cut off of 31 July 2014; Maximum time to response was 23.1 weeks

Collaborators and Investigators

• Sponsor: Celgene
• Investigators: Study Director: Mohamed Zaki, MD, PhD, Celgene Corporation

Publications and helpful links

General Publications

• 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.
• 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.
• Morgan G, Palumbo A, Dhanasiri S, Lee D, Weisel K, Facon T, Delforge M, Oriol A, Zaki M, Yu X, Sternas L, Jacques C, Akehurst R, Offner F, Dimopoulos MA. Overall survival of relapsed and refractory multiple myeloma patients after adjusting for crossover in the MM-003 trial for pomalidomide plus low-dose dexamethasone. Br J Haematol. 2015 Mar;168(6):820-3. doi: 10.1111/bjh.13227. Epub 2014 Nov 18.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2011
• Primary Completion (Actual): July 31, 2014
• Study Completion (Actual): July 31, 2014

Study Registration Dates

• First Submitted: March 27, 2011
• First Submitted That Met QC Criteria: March 27, 2011
• First Posted (Estimate): March 29, 2011

Study Record Updates

• Last Update Posted (Actual): November 19, 2019
• Last Update Submitted That Met QC Criteria: November 7, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Pomalidomide; Multiple Myeloma; Myeloma; Relapsed Multiple Myeloma; Refractory Myeloma; Relapsed and Refractory Multiple Myeloma; Resistant Multiple Myeloma; Treatment-resistant Multiple Myeloma; Lenalidomide-resistant; Bortezomib-resistant; Companion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Pomalidomide
• Other Study ID Numbers: CC-4047-MM-003/C; 2010-023343-16 (EudraCT Number)