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

Last updated: November 7, 2019
Sponsor: Celgene
Overall Status: Completed

Phase

3

Condition

Leukemia

Bone Diseases

Multiple Myeloma

Treatment

N/A

Clinical Study ID

NCT01324947
CC-4047-MM-003/C
2010-023343-16
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

  1. 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)

  1. Hypersensitivity to thalidomide or lenalidomide. (This includes ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy).

  2. Peripheral neuropathy ≥ Grade 2.

  3. 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.

  4. Subjects who are planning for or who are eligible for stem cell transplant.

  5. 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

  1. 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

  1. Use of any investigational agents within 28 days or 5 half lives (whichever is longer) of treatment.

  2. 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.

  3. Any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study.

  4. Incidence of gastrointestinal disease that may significantly alter the absorption of pomalidomide.

  5. Subjects unable or unwilling to undergo antithrombotic prophylactic treatment.

  6. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form.

  7. Pregnant or breastfeeding females.

  8. Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis A, B or C.

Study Design

Total Participants: 74
Study Start date:
March 01, 2011
Estimated Completion Date:
July 31, 2014

Connect with a study center

  • Royal Adelaide Hospital - SA Pathology Haematology

    Adelaide, 5000
    Australia

    Site Not Available

  • Princess Alexandra Hospital - Haematology

    Brisbane, 4102
    Australia

    Site Not Available

  • Royal Prince Alfred Hospital - Institute of Haematology

    Camperdown, 2050
    Australia

    Site Not Available

  • Peter McCallum Cancer Institute - Directorate of Cancer Medicine

    East Melbourne, 3002
    Australia

    Site Not Available

  • Frankston Hospital-Peninsula Health - Oncology Day Unit

    Frankston, 3199
    Australia

    Site Not Available

  • The Alfred Hospital - Malignant Haematology & Stem Cell Transplantation

    Melbourne, 3004
    Australia

    Site Not Available

  • Calvary Mater Newcastle - Haematology

    Waratah, 2298
    Australia

    Site Not Available

  • Border Medical Oncology

    Wodonga, 3690
    Australia

    Site Not Available

  • Wollongong Hospital - Haematology

    Wollongong, 2500
    Australia

    Site Not Available

  • UZ Gent - Hematology

    Gent, 9000
    Belgium

    Site Not Available

  • University Hospital Leuven - Hematology

    Leuven, 3000
    Belgium

    Site Not Available

  • Cliniques Universitaires ULC de Mont-Godinne - Hematology

    Yvoir, 5530
    Belgium

    Site Not Available

  • Tom Baker Cancer Center

    Calgary, Alberta T2N 4N2
    Canada

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • British Columbia Cancer Agency, Vancouver Centre

    Vancouver, British Columbia V5Z 1M9
    Canada

    Site Not Available

  • Queen Elizabeth II Health Sciences Centre

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Site Not Available

  • Juravinski Cancer Centre

    Hamilton, Ontario L8V 5C2
    Canada

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • Princess Margaret Hospital, University Health Network

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Royal Victoria Hospital

    Montreal, Quebec H3A1 A1
    Canada

    Site Not Available

  • Fakultní nemocnice Hradec Králové - Hematology

    Hradec Kralove, 50005
    Czech Republic

    Site Not Available

  • Charles University Hospital - Internal Medicine

    Prague, 12808
    Czechia

    Site Not Available

  • Aalborg Sygemus - Haematology

    Aalborg, 9000
    Denmark

    Site Not Available

  • Aarhus University Hospital

    Aarhus, 8000
    Denmark

    Site Not Available

  • Odense University Hospital

    Odense, 5000
    Denmark

    Site Not Available

  • Vejle Hospital - Hematology

    Vejle, 7100
    Denmark

    Site Not Available

  • CHU Angers - Service des maladies du sang

    Angers, 49033
    France

    Site Not Available

  • Centre Hospitalier de la côte basque - Hematologie

    Bayonne, 64019
    France

    Site Not Available

  • Centre Hospitalier Départemental Vendée - Onco-hematologie

    La Roche, 85925
    France

    Site Not Available

  • CHRU de Lille - Service des maladies du sang

    Lille, 59037
    France

    Site Not Available

  • Institut Paoli Calmette - Hematology 1

    Marseille, 13009
    France

    Site Not Available

  • CHU Hôtel-Dieu - Hematologie

    Nantes, 44093
    France

    Site Not Available

  • CHU Saint Antoine - Service des maladies du sang

    Paris, 75012
    France

    Site Not Available

  • Hôpital Saint Louis - Immuno-hematologie

    Paris, 75010
    France

    Site Not Available

  • CHRU - Hôpital du Haut Lévêque - Centre François Magendie Service des maladies du sang

    Pessac, 33604
    France

    Site Not Available

  • Centre Hospitalier Lyon sud - Hematologie

    Pierre, 69495
    France

    Site Not Available

  • Centre Hospitalier Lyon sud - Hematologie

    Pierre-Benite, 69495
    France

    Site Not Available

  • CHRU Hôpital Purpan - Hematologie

    Toulouse, 31059
    France

    Site Not Available

  • Hôpital Bretonneau - Hématologie & Thérapie cellulaire

    Tours, 37044
    France

    Site Not Available

  • CHU Nancy - Hematologie

    Vandoeuvre-les-Nancy, 54511
    France

    Site Not Available

  • Universitatsklinikum Carl Gustav Carus-Medizinische Klinik und Poliklinik I

    Dresden, 01307
    Germany

    Site Not Available

  • Universitätsklinikum Essen, Klinik für Hämatologie Westdeutsches Tumorzentrum

    Essen, 45122
    Germany

    Site Not Available

  • Askepios Klinik Altona-Abteilung Hamatologie und Internistische Onkologie

    Hamburg, 22763
    Germany

    Site Not Available

  • Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V

    Heidelberg, 69120
    Germany

    Site Not Available

  • Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie

    Jena, 07740
    Germany

    Site Not Available

  • Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A

    Münster, 48149
    Germany

    Site Not Available

  • Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A

    Münster, 48149
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II

    Tübingen, 72076
    Germany

    Site Not Available

  • Universitätsklinikum Ulm - Klinik fur Innere Medizin III

    Ulm, 89081
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II

    Würzburg, 97080
    Germany

    Site Not Available

  • Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II

    Würzburg, 97080
    Germany

    Site Not Available

  • University of Athens - Alexandra Hospital

    Athens, 14572
    Greece

    Site Not Available

  • Università degli Studi di Bologna - Policlinico S. Orsola - Hematology

    Bologna, 40138
    Italy

    Site Not Available

  • AO Universitaria San Martino - hematooncology

    Genova, 16132
    Italy

    Site Not Available

  • Fondazione "G. Pascale" - Hematology

    Napoli, 80131
    Italy

    Site Not Available

  • Ospedale San Luigi AO Luigi Gonzaga - Hematology

    Orbassano, 10043
    Italy

    Site Not Available

  • Universita degli Studi di Padova - Clinical & Experimental Medicine

    Padova, 35128
    Italy

    Site Not Available

  • Ospedale Guglielmo da Saliceto - hematooncology

    Piacenza, 29100
    Italy

    Site Not Available

  • Unità di Ematologia Arcispedale S. Maria Nuova - Haematology

    Reggio Emilia, 42100
    Italy

    Site Not Available

  • Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology

    Roma, 00161
    Italy

    Site Not Available

  • A.O.U. San Giovanni Battista - Hematology

    Torino, 10126
    Italy

    Site Not Available

  • VUMC - Hematology

    Amsterdam, 1081 HV
    Netherlands

    Site Not Available

  • Erasmus Medical Center - Hematology

    Rotterdam, 3015 CE
    Netherlands

    Site Not Available

  • University Medical Center - Hematology

    Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Hematological Research Center under the Russian Academy of Medical Sciences - Hematology & BMT

    Moscow, 125167
    Russian Federation

    Site Not Available

  • Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology

    Moscow, 125284
    Russian Federation

    Site Not Available

  • Russian Research Institute of Hematology and Blood Transfusion - Hematology

    St. Petersburg, 191024
    Russian Federation

    Site Not Available

  • State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology

    St. Petersburg, 197341
    Russian Federation

    Site Not Available

  • Hospital Germans Trias i Pujol - Hematology

    Badalona, 08916
    Spain

    Site Not Available

  • Hospital Clinic i Provincial de Barcelona - Hematology

    Barcelona, 08036
    Spain

    Site Not Available

  • Hospital de Donostia - Hematology

    Guipúzcoa, 20014
    Spain

    Site Not Available

  • Hospital de Donostia - Hematology

    Guipúzcoa, 20014
    Spain

    Site Not Available

  • Hospital 12 de Octubre - Hematology

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital de La Princesa - Hematology

    Madrid, 28006
    Spain

    Site Not Available

  • Hospital de Salamanca - Hematology

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Universitario Marqués de Valdecilla - Hematology

    Santander, 39008
    Spain

    Site Not Available

  • Hospital La Fe - Hematology

    Valencia, 46009
    Spain

    Site Not Available

  • Sahlgrenska Hospital, University of Goteborg - Hematology

    Goteborg, S-41345
    Sweden

    Site Not Available

  • Karolinska University Hospital Huddinge - Center of hematology

    Stockholm, 14152
    Sweden

    Site Not Available

  • Karolinska University Hospital Solna- medicine

    Stockholm, 17176
    Sweden

    Site Not Available

  • Karolinska University Hospital-medicine

    Stockholm, 14186
    Sweden

    Site Not Available

  • Overlakare Medocomcentrum - Hematology

    Uppsala, 75185
    Sweden

    Site Not Available

  • Inselspital, Institut für Medizinische Onkologie

    Bern, 3010
    Switzerland

    Site Not Available

  • Hôpitaux Universitaire de Genève - Oncologie

    Genève, 1211
    Switzerland

    Site Not Available

  • Hôpitaux Universitaire de Genève - Oncologie

    Genève, 1211
    Switzerland

    Site Not Available

  • Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich

    Zürich, 8091
    Switzerland

    Site Not Available

  • Royal Bournemouth Hospital - Haematology

    Bournemouth, BH7 7DW
    United Kingdom

    Site Not Available

  • St James's University Hospital - Haematology

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • King's College Hospital - Haematology Clinical Trials

    London, SE5 9RS
    United Kingdom

    Site Not Available

  • St Bartholomew's Hospital - Medical Oncology

    London, EC1A 7BE
    United Kingdom

    Site Not Available

  • Freeman Hospital - Northern Centre for Cancer Care

    Newcastle Upon Tyne, NE7 7DN
    United Kingdom

    Site Not Available

  • Nottingham City Hospital - Centre for Clinical Haematology

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Derriford Hospital - Haematology

    Plymouth, PL6 8DH
    United Kingdom

    Site Not Available

  • Royal hallamshire Hospital - Haematology

    Sheffield, S10 2JF
    United Kingdom

    Site Not Available

  • Royal Marsden NHS Foundation Trust - Haematology

    Surrey, SM2 5PT
    United Kingdom

    Site Not Available

  • Royal Wolverhampton Hospitals Trust - Research and Development

    Wolverhampton, WV10 OQP
    United Kingdom

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.