Phase
Condition
Lymphoproliferative Disorders
Platelet Disorders
Bone Neoplasm
Treatment
Carfilzomib
Pomalidomide
Dexamethasone
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
A confirmed diagnosis of multiple myeloma (must have an M-component in serum and/orurine)
Measurable disease defined as: i. M-spike ≥ 500mg/dL, or ii. Urine protein M-spike of ≥ 200 mg/day, or iii. Serumfree light chains ≥ 10 mg/dL, and an abnormal κ:λ ratio
Participant has documented relapsed or progressive MM on or after any regimen or whoare refractory to the most recent line of therapy. i. Relapsed MM is defined as previously treated MM that progresses and requiresinitiation of salvage therapy but does not meet the criteria for refractory MM. ii. Refractory MM is defined as disease that is nonresponsive (failure to achieveminimal response or development of progressive disease) while on primary or salvagetherapy or progresses within 60 days of last therapy.
In Part 1 should have relapsed or progressive disease and have had ≥ 3 priorlines of therapy including a proteasome inhibitor, an IMiD, and an anti-CD38monoclonal antibody, and no more available approved therapies.
Participants in Part 2 should have relapsed or progressive disease and have had ≥ 1 prior line of therapy
Prior treatment with carfilzomib is allowed but the patient must not beconsidered carfilzomib refractory by the investigator.
Positivity for t(11;14) translocation must be confirmed by validated fluorescence insitu hybridization (FISH) testing assay in a pre-defined laboratory a. fresh bone marrow aspirate sample must be collected at screening and sent tocentral laboratory for t(11;14) FISH testing.
Adequate organ function defined as:
Hemoglobin ≥ 8.0 g/dL within 7 days before first dose of study treatment, (transfusions, in accordance with institutional guidelines, are permitted)
Platelet count ≥ 75,000/μL, within 7 days before first dose of study treatment,independent of growth factor support and transfusions
Absolute neutrophil count (ANC) ≥ 1000/mm^3 within 7 days before first dose ofstudy treatment
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upperlimit of normal (ULN) and total bilirubin ≤ 2.0 x ULN N (total bilirubin mustbe < 3 x ULN for patients with Gilbert's syndrome)
Exclusion
Exclusion Criteria:
Participant has any of the following conditions:
Non secretory MM (Serum free light chains < 10 mg/dL)
Solitary plasmacytoma
Active plasma cell leukemia (ie, either 20% of peripheral white blood cells or > 2.0 x 109/L circulating plasma cells by standard differential)
Waldenström macroglobulinemia
Amyloidosis.
Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, skin changes (POEMS) syndrome
Chronic respiratory disease that requires continuous oxygen
Significant cardiovascular disease, including but not limited to:
Myocardial infarction ≤ 6 months before screening
Ejection fraction ≤ 50%
Unstable angina≤ 3 months before screening
New York Heart Association Class III or IV congestive heart failure
History of clinically significant arrhythmias (eg, sustained ventriculartachycardia, ventricular fibrillation, or torsades de pointes)
Heart rate-corrected QT interval > 480 milliseconds based on Fridericia'sformula
History of Mobitz II second-degree or third-degree heart block without apermanent pacemaker in place
Uncontrolled hypertension at screening, defined as systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHg by ≥ 2 consecutivemeasurements. Prior therapy with sonrotoclax or other agents inhibiting BCL2activity (eg, venetoclax)
Known infection with human immunodeficiency virus (HIV)
Serologic status reflecting active viral hepatitis B (HBV) or viral hepatitis C (HCV) infection as follows:
Presence of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb). Participants with presence of HBcAb, but absence of HBsAg, areeligible if HBV DNA is undetectable (limitation of sensitivity < 20 IU/mL) ,),and if they are willing to undergo monthly monitoring for HBV reactivation.
Presence of HCV antibody. Participants with presence of HCV antibody areeligible if HCV RNA is undetectable (limitation of sensitivity < 15 IU/mL).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Canberra Hospital
Garra, Australian Capital Territory 2605
AustraliaSite Not Available
Canberra Hospital
Garran, Australian Capital Territory 2605
AustraliaSite Not Available
Nepean Hospital
Kingswood, New South Wales 2747
AustraliaActive - Recruiting
Monash Health
Clayton, Victoria 3168
AustraliaActive - Recruiting
St Vincents Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
Monash Health
Melbourne, Victoria
AustraliaActive - Recruiting
The Alfred Hospital
Melbourne, Victoria 3004
AustraliaActive - Recruiting
Royal Perth Hospital
Perth, Western Australia 6000
AustraliaActive - Recruiting
St. Vincent's Hospital Melbourne
Fitzroy, 3065
AustraliaActive - Recruiting
Hospital Sirio Libanes Brasilia
Brasilia, 70200-730
BrazilActive - Recruiting
Instituto Dor de Pesquisa E Ensino Distrito Federal
Brasilia, 70390140
BrazilActive - Recruiting
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus
Porto Alegre, 90850-170
BrazilActive - Recruiting
Hospital Sao Rafael (Rede Dor)
Salvador, 41253-190
BrazilSite Not Available
Accamargo Cancer Center
Sao Paulo, 01508-010
BrazilActive - Recruiting
Clinica Sao Germano
Sao Paulo, 04537-080
BrazilActive - Recruiting
Hospital Nove de Julho Dasa
Sao Paulo, 01409-902
BrazilActive - Recruiting
Hospital Sirio Libanes
Sao Paulo, 01308-050
BrazilActive - Recruiting
Hospital Sirio Libanes Sao Paulo
Sao Paulo, 01308-050
BrazilActive - Recruiting
Instituto Dor de Pesquisa E Ensino Sao Paulo
Sao Paulo, 01401-002
BrazilActive - Recruiting
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Sao Paulo, 05653-120
BrazilActive - Recruiting
Cross Cancer Institute
Edmonton, Alberta T6G1Z2
CanadaActive - Recruiting
British Columbia Cancer Agency the Vancouver Centre
Vancouver, British Columbia V5Z 4E6
CanadaActive - Recruiting
British Columbia Cancer Center
Vancouver, British Columbia V5Z4E6
CanadaSite Not Available
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2C9
CanadaActive - Recruiting
University Health Network - Princess Margaret Cancer Centre
Toronto, Ontario M5G 2C9
CanadaSite Not Available
Jewish General Hospital
Montreal, Quebec QC H3t 1E2
CanadaActive - Recruiting
CIUSSS de l'Est de-L'Île-de-Montréal installation Hôpital Maisonneuve-Rosemont
Montréal, Quebec H1T2M4
CanadaSite Not Available
Jewish General Hospital
Montréal, Quebec H3T1E2
CanadaSite Not Available
The First Affiliated Hospital of Wannan Medical College
Wuhu, Anhui 241001
ChinaSite Not Available
Beijing Chao Yang Hospital
Beijing, Beijing 100020
ChinaActive - Recruiting
Peking University Peoples Hospital
Beijing, Beijing 100044
ChinaActive - Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing 400030
ChinaActive - Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
ChinaActive - Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian 361003
ChinaActive - Recruiting
Sun Yat Sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting
The First Affiliated Hospital, Sun Yat Sen University
Guangzhou, Guangdong 510080
ChinaSite Not Available
Jieyang Peoples Hospital (Jieyang Affiliated Hospital, Sun Yat Sen University )
Jieyang, Guangdong 522000
ChinaSite Not Available
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei 050000
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou, Henan 450000
ChinaActive - Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan 450052
ChinaActive - Recruiting
Hunan Cancer Hospital
Changsha, Hunan 410013
ChinaActive - Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu 210029
ChinaActive - Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu 221000
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University Branch Donghu
Nanchang, Jiangxi 330006
ChinaSite Not Available
The First Affiliated Hospital of Nanchang University Branch Xianghu
Nanchang, Jiangxi 332000
ChinaActive - Recruiting
The First Hospital of China Medical University
Shenyang, Liaoning 110001
ChinaActive - Recruiting
Qingdao Municipal Hospital
Qingdao, Shandong 266000
ChinaActive - Recruiting
Affiliated Zhongshan Hospital of Fudan University
Shanghai, Shanghai 200032
ChinaActive - Recruiting
Shanghai Fourth Peoples Hospital Affiliated to Tongji University
Shanghai, Shanghai 200434
ChinaActive - Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin 300052
ChinaActive - Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
Hopital Claude Huriez Chu Lille
Lille, 59000
FranceActive - Recruiting
Centre Hospitalier Universitaire Nantes Hotel Dieu
Nantes Cedex, 44093
FranceActive - Recruiting
Chu de Poitiers Site de La Mileterie
Poitiers, 86000
FranceActive - Recruiting
Universitaetsklinikum Aachen
Aachen, 52074
GermanySite Not Available
Universitatsklinikum Carl Gustav Carus An Der Technischen Universitat Dresden
Dresden, 01307
GermanyActive - Recruiting
Universitatsklinikum Hamburg Eppendorf
Hamburg, 20251
GermanyActive - Recruiting
Universitatsklinikum Wurzburg
Wurzburg, 97080
GermanySite Not Available
University Hospital of Alexandroupolis
Alexandroupolis, 68100
GreeceActive - Recruiting
General Hospital of Athens Alexandra
Athens, 11528
GreeceActive - Recruiting
Rabin Medical Center
Petach Tikva, 49100
IsraelActive - Recruiting
Rabin Medical Center
Petah Tikva, 49100
IsraelSite Not Available
Sourasky Medical Center
Tel Aviv, 6423906
IsraelActive - Recruiting
Azienda Ospedaliera Policlinico Di Bari
Bari, 70124
ItalyActive - Recruiting
Policlinico Sorsola Malpighi, Aou Di Bologna
Bologna, 40138
ItalyActive - Recruiting
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori Irst
Meldola, 47014
ItalyActive - Recruiting
Istituto Europeo Di Oncologia
Milano, 20141
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
ItalyActive - Recruiting
Istituto Di Candiolo Irccs
Torino, 10060
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Delle Marche
Torrette, 60020
ItalyActive - Recruiting
Asan Medical Center
Seoul, Seoul Teugbyeolsi 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, Seoul Teugbyeolsi 06351
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi 03080
Korea, Republic ofActive - Recruiting
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic ofActive - Recruiting
The Catholic University of Korea, Seoul St Marys Hospital
Seoul, Seoul Teugbyeolsi 06591
Korea, Republic ofActive - Recruiting
Aotearoa Clinical Trials
Auckland, 2025
New ZealandActive - Recruiting
Middlemore Hospital
Auckland, 1640
New ZealandActive - Recruiting
National University Hospital Singapore
Singapore, 119074
SingaporeActive - Recruiting
Hospital Clinic de Barcelona
Barcelona, 8036
SpainActive - Recruiting
Hospital San Pedro de Alcantara
Caceres, 10003
SpainActive - Recruiting
Hospital Universitario Virgen de La Victoria
Malaga, 29010
SpainActive - Recruiting
Hospital Universitario Virgen Del Rocio
Sevilla, 41013
SpainActive - Recruiting
Inselspital Bern (Inselspital, Universitatsspital Bern)
Bern, 3010
SwitzerlandSite Not Available
Churchill Hospital Oxford University Hospital Nhs Trust
Headington, OX3 7LE
United KingdomActive - Recruiting
University College Hospital
London, NW1 2PG
United KingdomActive - Recruiting
Royal Marsden Nhs Foundation Royal Marsden Hospital
Sutton, SM2 5PT
United KingdomActive - Recruiting
Royal Cornwall Hospitalsnhs Trust
Truro, TR1 3LJ
United KingdomActive - Recruiting
University of Alabama At Birmingham Hospital
Birmingham, Alabama 35294
United StatesActive - Recruiting
University of Alabama at Birmingham
Birmingham, Alabama 35294
United StatesSite Not Available
City of Hope National Medical Center
Duarte, California 91010
United StatesActive - Recruiting
City of Hope At Irvine Lennar
Irvine, California 92618
United StatesActive - Recruiting
Valkyrie Clinical Trials
Los Angeles, California 90067
United StatesSite Not Available
University of California At San Francisco
San Francisco, California 94143
United StatesSite Not Available
Sylvester Cancer Centre, University of Miami
Miami, Florida 33136
United StatesActive - Recruiting
University of Miami
Miami, Florida 33136
United StatesActive - Recruiting
Tampa General Hospital
Tampa, Florida 33606
United StatesSite Not Available
Emory University Winship Cancer Center
Atlanta, Georgia 30322
United StatesActive - Recruiting
Winship Cancer Institute of Emory
Atlanta, Georgia 30322
United StatesSite Not Available
University of Chicago Medical Center
Chicago, Illinois 60637
United StatesActive - Recruiting
University of Illinois Cancer Center
Chicago, Illinois 60612
United StatesSite Not Available
Southern Illinois University School of Medicine
Springfield, Illinois 62629
United StatesActive - Recruiting
Luminis Health Anne Arundel Medical Center
Annapolis, Maryland 21401
United StatesSite Not Available
Maryland Oncology
Columbia, Maryland 21044
United StatesSite Not Available
Maryland Oncology Hematology, Pa
Columbia, Maryland 21044
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesActive - Recruiting
Emory University Winship Cancer Center
Detroit, Michigan 30322
United StatesSite Not Available
Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Hackensack University Medical Center
Hackensack, New Jersey 07601
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center Mskcc
New York, New York 10065
United StatesActive - Recruiting
Weill Cornell Medical College Newyork Presbyterian Hospital
New York, New York 10021
United StatesActive - Recruiting
Ohio State University Comprehensive Cancer Center- James Cancer Hospital
Columbus, Ohio 43210
United StatesSite Not Available
The James Cancer Hospital and Solove Research Institute At Ohio State University
Columbus, Ohio 43210
United StatesActive - Recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
United StatesSite Not Available
Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesActive - Recruiting
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah 84112
United StatesSite Not Available
University of Washington
Seattle, Washington 98195
United StatesActive - Recruiting
University of Wisconsin
Madison, Wisconsin 53792
United StatesSite Not Available
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin 53792
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
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