Phase
Condition
Leukemia
Bone Diseases
Multiple Myeloma
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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).
Must be ≥ 18 years at the time of signing the informed consent form.
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.
Must be able to adhere to the study visit schedule and other protocol requirements.
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).
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.
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.
Females must agree to abstain from breastfeeding during study participation and 28 days after study discontinuation.
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. .
Males must also agree to refrain from donating semen or sperm while on pomalidomide and for 28 days after discontinuation from this study treatment.
All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment.
All subjects must agree not to share study medication
Exclusion Criteria
- The presence of any of the following will exclude a subject from enrollment:
Subjects with multiple myeloma who were not treated as a part of Study CC-4047-MM-003 (Arm B).
Subjects who received any anti-myeloma or anti-cancer therapies within the last 14 days of wash-out period before initiation of study treatment.
Subjects who discontinued CC-4047-MM-003 study ≥120 days.
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.
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
- 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)
Hypersensitivity to thalidomide or lenalidomide. (This includes ≥ Grade 3 rash during prior thalidomide or lenalidomide therapy).
Peripheral neuropathy ≥ Grade 2.
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.
Subjects who are planning for or who are eligible for stem cell transplant.
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
- 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
Use of any investigational agents within 28 days or 5 half lives (whichever is longer) of treatment.
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.
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 subject from signing the informed consent form.
Pregnant or breastfeeding females.
Known human immunodeficiency virus (HIV) positivity or active infectious hepatitis A, B or C.
Study Design
Connect with a study center
Royal Adelaide Hospital - SA Pathology Haematology
Adelaide, 5000
AustraliaSite Not Available
Princess Alexandra Hospital - Haematology
Brisbane, 4102
AustraliaSite Not Available
Royal Prince Alfred Hospital - Institute of Haematology
Camperdown, 2050
AustraliaSite Not Available
Peter McCallum Cancer Institute - Directorate of Cancer Medicine
East Melbourne, 3002
AustraliaSite Not Available
Frankston Hospital-Peninsula Health - Oncology Day Unit
Frankston, 3199
AustraliaSite Not Available
The Alfred Hospital - Malignant Haematology & Stem Cell Transplantation
Melbourne, 3004
AustraliaSite Not Available
Calvary Mater Newcastle - Haematology
Waratah, 2298
AustraliaSite Not Available
Border Medical Oncology
Wodonga, 3690
AustraliaSite Not Available
Wollongong Hospital - Haematology
Wollongong, 2500
AustraliaSite Not Available
UZ Gent - Hematology
Gent, 9000
BelgiumSite Not Available
University Hospital Leuven - Hematology
Leuven, 3000
BelgiumSite Not Available
Cliniques Universitaires ULC de Mont-Godinne - Hematology
Yvoir, 5530
BelgiumSite Not Available
Tom Baker Cancer Center
Calgary, Alberta T2N 4N2
CanadaSite Not Available
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
CanadaSite Not Available
British Columbia Cancer Agency, Vancouver Centre
Vancouver, British Columbia V5Z 1M9
CanadaSite Not Available
Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia B3H 2Y9
CanadaSite Not Available
Juravinski Cancer Centre
Hamilton, Ontario L8V 5C2
CanadaSite Not Available
London Health Sciences Centre
London, Ontario N6A 5W9
CanadaSite Not Available
Princess Margaret Hospital, University Health Network
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Maisonneuve-Rosemont Hospital
Montreal, Quebec H1T 2M4
CanadaSite Not Available
Royal Victoria Hospital
Montreal, Quebec H3A1 A1
CanadaSite Not Available
Fakultní nemocnice Hradec Králové - Hematology
Hradec Kralove, 50005
Czech RepublicSite Not Available
Charles University Hospital - Internal Medicine
Prague, 12808
CzechiaSite Not Available
Aalborg Sygemus - Haematology
Aalborg, 9000
DenmarkSite Not Available
Aarhus University Hospital
Aarhus, 8000
DenmarkSite Not Available
Odense University Hospital
Odense, 5000
DenmarkSite Not Available
Vejle Hospital - Hematology
Vejle, 7100
DenmarkSite Not Available
CHU Angers - Service des maladies du sang
Angers, 49033
FranceSite Not Available
Centre Hospitalier de la côte basque - Hematologie
Bayonne, 64019
FranceSite Not Available
Centre Hospitalier Départemental Vendée - Onco-hematologie
La Roche, 85925
FranceSite Not Available
CHRU de Lille - Service des maladies du sang
Lille, 59037
FranceSite Not Available
Institut Paoli Calmette - Hematology 1
Marseille, 13009
FranceSite Not Available
CHU Hôtel-Dieu - Hematologie
Nantes, 44093
FranceSite Not Available
CHU Saint Antoine - Service des maladies du sang
Paris, 75012
FranceSite Not Available
Hôpital Saint Louis - Immuno-hematologie
Paris, 75010
FranceSite Not Available
CHRU - Hôpital du Haut Lévêque - Centre François Magendie Service des maladies du sang
Pessac, 33604
FranceSite Not Available
Centre Hospitalier Lyon sud - Hematologie
Pierre, 69495
FranceSite Not Available
Centre Hospitalier Lyon sud - Hematologie
Pierre-Benite, 69495
FranceSite Not Available
CHRU Hôpital Purpan - Hematologie
Toulouse, 31059
FranceSite Not Available
Hôpital Bretonneau - Hématologie & Thérapie cellulaire
Tours, 37044
FranceSite Not Available
CHU Nancy - Hematologie
Vandoeuvre-les-Nancy, 54511
FranceSite Not Available
Universitatsklinikum Carl Gustav Carus-Medizinische Klinik und Poliklinik I
Dresden, 01307
GermanySite Not Available
Universitätsklinikum Essen, Klinik für Hämatologie Westdeutsches Tumorzentrum
Essen, 45122
GermanySite Not Available
Askepios Klinik Altona-Abteilung Hamatologie und Internistische Onkologie
Hamburg, 22763
GermanySite Not Available
Universitätsklinikum Heidelberg - Medizinische Klinik und Poliklinik V
Heidelberg, 69120
GermanySite Not Available
Universitätsklinikum Jena - Klinik fur Innere Medizin II-Hamatologie/Onkologie
Jena, 07740
GermanySite Not Available
Universitätsklinikum Leipzig - Medizinische Klinik und Poliklinik II
Leipzig, 04103
GermanySite Not Available
Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A
Münster, 48149
GermanySite Not Available
Universitätsklinikum Münster - Medizinische Klinik und Poliklinik A
Münster, 48149
GermanySite Not Available
Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II
Tübingen, 72076
GermanySite Not Available
Universitätsklinikum Tübingen - Medizinische Klinik und Poliklinik - Abteilung II
Tübingen, 72076
GermanySite Not Available
Universitätsklinikum Ulm - Klinik fur Innere Medizin III
Ulm, 89081
GermanySite Not Available
Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II
Würzburg, 97080
GermanySite Not Available
Universitätsklinikum Würzburg - Medizinische Klinik und Poliklinik II
Würzburg, 97080
GermanySite Not Available
University of Athens - Alexandra Hospital
Athens, 14572
GreeceSite Not Available
Università degli Studi di Bologna - Policlinico S. Orsola - Hematology
Bologna, 40138
ItalySite Not Available
AO Universitaria San Martino - hematooncology
Genova, 16132
ItalySite Not Available
Fondazione "G. Pascale" - Hematology
Napoli, 80131
ItalySite Not Available
Ospedale San Luigi AO Luigi Gonzaga - Hematology
Orbassano, 10043
ItalySite Not Available
Universita degli Studi di Padova - Clinical & Experimental Medicine
Padova, 35128
ItalySite Not Available
Ospedale Guglielmo da Saliceto - hematooncology
Piacenza, 29100
ItalySite Not Available
Unità di Ematologia Arcispedale S. Maria Nuova - Haematology
Reggio Emilia, 42100
ItalySite Not Available
Policlinico Umberto I, Università "La Sapienza" di Roma - Hematology
Roma, 00161
ItalySite Not Available
A.O.U. San Giovanni Battista - Hematology
Torino, 10126
ItalySite Not Available
VUMC - Hematology
Amsterdam, 1081 HV
NetherlandsSite Not Available
Erasmus Medical Center - Hematology
Rotterdam, 3015 CE
NetherlandsSite Not Available
University Medical Center - Hematology
Utrecht, 3584 CX
NetherlandsSite Not Available
Hematological Research Center under the Russian Academy of Medical Sciences - Hematology & BMT
Moscow, 125167
Russian FederationSite Not Available
Moscow State Medical Institution Municipal Clinical Hospital n.a. S.P. Botkin - Hematology
Moscow, 125284
Russian FederationSite Not Available
Russian Research Institute of Hematology and Blood Transfusion - Hematology
St. Petersburg, 191024
Russian FederationSite Not Available
State Higher Educational Institution St. Petersburg State Medical University - Onco-hematology
St. Petersburg, 197341
Russian FederationSite Not Available
Hospital Germans Trias i Pujol - Hematology
Badalona, 08916
SpainSite Not Available
Hospital Clinic i Provincial de Barcelona - Hematology
Barcelona, 08036
SpainSite Not Available
Hospital de Donostia - Hematology
Guipúzcoa, 20014
SpainSite Not Available
Hospital de Donostia - Hematology
Guipúzcoa, 20014
SpainSite Not Available
Hospital 12 de Octubre - Hematology
Madrid, 28041
SpainSite Not Available
Hospital de La Princesa - Hematology
Madrid, 28006
SpainSite Not Available
Hospital de Salamanca - Hematology
Salamanca, 37007
SpainSite Not Available
Hospital Universitario Marqués de Valdecilla - Hematology
Santander, 39008
SpainSite Not Available
Hospital La Fe - Hematology
Valencia, 46009
SpainSite Not Available
Sahlgrenska Hospital, University of Goteborg - Hematology
Goteborg, S-41345
SwedenSite Not Available
Karolinska University Hospital Huddinge - Center of hematology
Stockholm, 14152
SwedenSite Not Available
Karolinska University Hospital Solna- medicine
Stockholm, 17176
SwedenSite Not Available
Karolinska University Hospital-medicine
Stockholm, 14186
SwedenSite Not Available
Overlakare Medocomcentrum - Hematology
Uppsala, 75185
SwedenSite Not Available
Inselspital, Institut für Medizinische Onkologie
Bern, 3010
SwitzerlandSite Not Available
Hôpitaux Universitaire de Genève - Oncologie
Genève, 1211
SwitzerlandSite Not Available
Hôpitaux Universitaire de Genève - Oncologie
Genève, 1211
SwitzerlandSite Not Available
Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich
Zürich, 8091
SwitzerlandSite Not Available
Klinik und Poliklinik für Onkologie - UniversitätsSpital Zürich
Zürich, 8091
SwitzerlandSite Not Available
Royal Bournemouth Hospital - Haematology
Bournemouth, BH7 7DW
United KingdomSite Not Available
St James's University Hospital - Haematology
Leeds, LS9 7TF
United KingdomSite Not Available
King's College Hospital - Haematology Clinical Trials
London, SE5 9RS
United KingdomSite Not Available
St Bartholomew's Hospital - Medical Oncology
London, EC1A 7BE
United KingdomSite Not Available
Freeman Hospital - Northern Centre for Cancer Care
Newcastle Upon Tyne, NE7 7DN
United KingdomSite Not Available
Nottingham City Hospital - Centre for Clinical Haematology
Nottingham, NG5 1PB
United KingdomSite Not Available
Derriford Hospital - Haematology
Plymouth, PL6 8DH
United KingdomSite Not Available
Royal hallamshire Hospital - Haematology
Sheffield, S10 2JF
United KingdomSite Not Available
Royal Marsden NHS Foundation Trust - Haematology
Surrey, SM2 5PT
United KingdomSite Not Available
Royal Wolverhampton Hospitals Trust - Research and Development
Wolverhampton, WV10 OQP
United KingdomSite 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.