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| Name | Class |
|---|---|
| Celgene Corporation | INDUSTRY |
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The purpose of this study is to compare the efficacy and safety of arlo-cel (BMS-986393) versus standard regimens in adult participants with Relapsed or Refractory and Lenalidomide-exposed Multiple Myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986393 | Drug | Specified dose on specified days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival (PFS) | Up to 5 years after the last participant is randomized | |
| Minimal residual disease (MRD)-negativity in complete response (CR) | Up to 1 year after the last participant is randomized |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Up to 5 years after the last participant is randomized | |
| Overall response rate (ORR) | Up to 5 years after the last participant is randomized | |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35205 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
See Plan Description
See Plan Description
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| Cyclophosphamide | Drug | Specified dose on specified days |
|
| Fludarabine | Drug | Specified dose on specified days |
|
| Daratumumab | Drug | Specified dose on specified days |
|
| Pomalidomide | Drug | Specified dose on specified days |
|
| Dexamethasone | Drug | Specified dose on specified days |
|
| Carfilzomib | Drug | Specified dose on specified days |
|
| Minimal residual disease (MRD)-negative status |
| Up to 5 years after the last participant is randomized |
| Complete response rate (CRR) | Up to 5 years after the last participant is randomized |
| Time to response (TTR) | Up to 5 years after the last participant is randomized |
| Duration of response (DOR) | Up to 5 years after the last participant is randomized |
| Maximum observed concentration (Cmax) of transgene level | Up to 5 years after the last participant is randomized |
| Time of maximum observed plasma concentration (Tmax) of transgene level | Up to 5 years after the last participant is randomized |
| Area under the concentration-time curve (AUC) of transgene level | Up to 5 years after the last participant is randomized |
| Changes from baseline in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire- Core 30 items (QLQ-C30) primary domains | EORTC QLQ-C30 primary domains: fatigue, pain, physical functioning, role functioning, cognitive functioning, and global health status/quality of life (QoL). | Up to 5 years after the last participant is randomized |
| Changes from baseline in EORTC Quality of Life Multiple Myeloma Module- 20 items (QLQ-MY20) primary domains | EORTC QLQ-MY20 primary domains: disease symptoms and side effects of treatment | Up to 5 years after the last participant is randomized |
| Time to meaningful improvement in EORTC QLQ-C30 global health status/QoL. | Up to 5 years after the last participant is randomized |
| UCLA Hematology/Oncology - Santa Monica | Recruiting | Los Angeles | California | 90404 | United States |
|
| University of California, Irvine (UCI) Health - UC Irvine Medical Center | Recruiting | Orange | California | 92868 | United States |
|
| Local Institution - 0223 | Not yet recruiting | Washington D.C. | District of Columbia | 20007 | United States |
|
| Baptist MD Anderson Cancer Center | Recruiting | Jacksonville | Florida | 32207 | United States |
|
| University of Miami Hospital and Clinics, Sylvester Cancer Center | Recruiting | Miami | Florida | 33136 | United States |
|
| Local Institution - 0228 | Not yet recruiting | Orlando | Florida | 32803 | United States |
|
| Winship Cancer Institute, Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
|
| Louisiana State University Health Sciences Shreveport | Recruiting | Shreveport | Louisiana | 71103 | United States |
|
| Boston Medical Center | Recruiting | Boston | Massachusetts | 02118 | United States |
|
| Local Institution - 0219 | Not yet recruiting | Minneapolis | Minnesota | 55455 | United States |
|
| Weill Cornell Medical College | Recruiting | New York | New York | 10065 | United States |
|
| Local Institution - 0221 | Not yet recruiting | Stony Brook | New York | 11794 | United States |
|
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
|
| Levine Cancer Institute | Recruiting | Charlotte | North Carolina | 28204 | United States |
|
| Cleveland Clinic | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| Fox Chase Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19111 | United States |
|
| Local Institution - 0232 | Not yet recruiting | Pittsburgh | Pennsylvania | 15224 | United States |
|
| Local Institution - 0227 | Not yet recruiting | Charleston | South Carolina | 29425 | United States |
|
| University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| Medical College of Wisconsin | Recruiting | Milwaukee | Wisconsin | 53226 | United States |
|
| Hospital Italiano de Buenos Aires | Recruiting | ABB | Buenos Aires F.D. | C1199ABB | Argentina |
|
| Local Institution - 0214 | Withdrawn | ABB | Buenos Aires F.D. | C1199ABB | Argentina |
| Hospital Aleman | Recruiting | Buenos Aires | Buenos Aires F.D. | C1118AAT | Argentina |
|
| Royal Prince Alfred Hospital | Recruiting | Camperdown | New South Wales | 2050 | Australia |
|
| Liverpool Hospital | Recruiting | Liverpool | New South Wales | 2170 | Australia |
|
| Princess Alexandra Hospital | Recruiting | Brisbane | Queensland | 4102 | Australia |
|
| Royal Adelaide Hospital | Recruiting | Adelaide | South Australia | 5000 | Australia |
|
| Monash Health | Recruiting | Clayton | Victoria | 3168 | Australia |
|
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | 3000 | Australia |
|
| The Alfred Hospital | Recruiting | Melbourne | Victoria | 3004 | Australia |
|
| Fiona Stanley Hospital | Recruiting | Murdoch | Western Australia | 6150 | Australia |
|
| Ordensklinikum Linz GmbH Elisabethinen | Recruiting | Linz | Upper Austria | 4020 | Austria |
|
| Hanusch-Krankenhaus | Recruiting | Vienna | 1140 | Austria |
|
| Antwerp University Hospital | Recruiting | Edegem | Antwerpen | 2650 | Belgium |
|
| Cliniques universitaires Saint-Luc | Recruiting | Brussels | Bruxelles-Capitale, Région de | 1200 | Belgium |
|
| Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne | Recruiting | Yvoir | Namur | 5530 | Belgium |
|
| UZ Gent | Recruiting | Ghent | Oost-Vlaanderen | 9000 | Belgium |
|
| Local Institution - 0012 | Not yet recruiting | Nova Lima | Minas Gerais | 34000-000 | Brazil |
|
| A. C. Camargo Cancer Center | Recruiting | São Paulo | São Paulo | 01509-010 | Brazil |
|
| Instituto D'Or de Pesquisa e Ensino (IDOR) | Recruiting | São Paulo | 01401-002 | Brazil |
|
| Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein | Recruiting | São Paulo | 05652-900 | Brazil |
|
| Arthur J.E. Child Comprehensive Cancer Centre | Recruiting | Calgary | Alberta | T2N 5G2 | Canada |
|
| Vancouver General Hospital | Recruiting | Vancouver | British Columbia | V5Z 1M9 | Canada |
|
| QEII Health Sciences Centre - Victoria General Site | Recruiting | Halifax | Nova Scotia | B3H 2Y9 | Canada |
|
| Local Institution - 0192 | Not yet recruiting | Hamilton | Ontario | L8V5C2 | Canada |
|
| CIUSSS de l'Est-de-l'Île-de-Montréal | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
|
| Fakultní nemocnice Brno Bohunice | Recruiting | Brno | Brno-město | 625 00 | Czechia |
|
| Fakultni nemocnice Hradec Kralove | Recruiting | Hradec Králové | Hradec Králové | 500 05 | Czechia |
|
| Fakultni nemocnice Ostrava | Recruiting | Ostrava | Moravian-Silesian Region | 708 52 | Czechia |
|
| Vseobecna fakultni nemocnice v Praze | Recruiting | Prague | 12808 | Czechia |
|
| Rigshospitalet | Recruiting | Copenhagen | Capital Region | 2100 | Denmark |
|
| Aarhus Universitetshospital, Skejby | Recruiting | Aarhus | Central Jutland | 8200 | Denmark |
|
| Roskilde Sygehus | Recruiting | Roskilde | Region Sjælland | 4000 | Denmark |
|
| Odense Universitetshospital | Recruiting | Odense | Region Syddanmark | 5000 | Denmark |
|
| Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) | Recruiting | Helsinki | Uusimaa | 00029 | Finland |
|
| Oulun yliopistollinen sairaala | Recruiting | Oulu | 90220 | Finland |
|
| Turku University Hospital | Recruiting | Turku | 20251 | Finland |
|
| Hopital Claude Huriez - CHU de Lille | Recruiting | Lille | Nord | 59000 | France |
|
| Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu | Recruiting | Nantes | Pays de la Loire Region | 44000 | France |
|
| Centre Hospitalier Lyon Sud | Recruiting | Pierre-Bénite | Rhône | 69310 | France |
|
| Henri Mondor Hospital | Recruiting | Créteil | Val-de-Marne | 94010 | France |
|
| Hôpital Saint-Louis | Recruiting | Paris | 75010 | France |
|
| TUM Klinikum | Recruiting | Munich | Bavaria | 81675 | Germany |
|
| Medizinische Hochschule Hannover | Recruiting | Hanover | Lower Saxony | 30625 | Germany |
|
| Klinikum Chemnitz - Flemmingstraße | Recruiting | Chemnitz | Saxony | 09116 | Germany |
|
| Universitätsklinikum Leipzig | Recruiting | Leipzig | Saxony | 04103 | Germany |
|
| Universitaetsklinikum Magdeburg | Recruiting | Magdeburg | Saxony-Anhalt | 39120 | Germany |
|
| Universitaetsklinikum Schleswig-Holstein Campus Kiel | Recruiting | Kiel | Schleswig-Holstein | 24105 | Germany |
|
| Charité Campus Virchow-Klinikum | Recruiting | Berlin | 13353 | Germany |
|
| Universitaetsklinikum Hamburg-Eppendorf | Recruiting | Hamburg | 20246 | Germany |
|
| Universitaetsklinikum Heidelberg | Recruiting | Heidelberg | D-69120 | Germany |
|
| Klinikum Nuernberg Nord | Recruiting | Nuremberg | 90419 | Germany |
|
| Universitaetsklinikum Wuerzburg | Recruiting | Würzburg | 97080 | Germany |
|
| University Hospital of Patras | Recruiting | Pátrai | Achaḯa | 26504 | Greece |
|
| Evangelismos General Hospital of Athens | Recruiting | Athens | Attikí | 106 76 | Greece |
|
| Attikon General University Hospital | Recruiting | Chaïdári | Attikí | 12462 | Greece |
|
| Debreceni Egyetem Klinikai Kozpont | Recruiting | Debrecen | Hajdú-Bihar | 4032 | Hungary |
|
| Local Institution - 0125 | Not yet recruiting | Budapest | 1097 | Hungary |
|
| Sheba Medical Center | Recruiting | Ramat Gan | Central District | 5262100 | Israel |
|
| Hadassah Medical Center | Recruiting | Jerusalem | Jerusalem | 9112001 | Israel |
|
| Sourasky Medical Center | Recruiting | Tel Aviv | Tell Abīb | 6423906 | Israel |
|
| Fondazione IRCCS Istituto Nazionale dei Tumori | Recruiting | Milan | Lombardy | 20133 | Italy |
|
| Istituto Clinico Humanitas | Recruiting | Rozzano | Milano | 20089 | Italy |
|
| Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino | Recruiting | Turin | Piedmont | 10126 | Italy |
|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola | Recruiting | Bologna | 40138 | Italy |
|
| Ospedale San Martino | Recruiting | Genova | 16132 | Italy |
|
| P.O. "S. Maria della Misericordia" Azienda Sanitaria Universitaria Friuli Centrale | Recruiting | Udine | 33100 | Italy |
|
| Nagoya City University Hospital | Recruiting | Nagoya | Aichi-ken | 467-8602 | Japan |
|
| National Cancer Center Hospital East | Recruiting | Kashiwa | Chiba | 277-8577 | Japan |
|
| Hyogo Medical University Hospital | Recruiting | Nishinomiya | Hyōgo | 663-8501 | Japan |
|
| Kanazawa University Hospital | Recruiting | Kanazawa | Ishikawa-ken | 920-8641 | Japan |
|
| Japanese Red Cross Medical Center | Recruiting | Shibuya-ku | Tokyo | 150-8935 | Japan |
|
| Kyushu University Hospital | Recruiting | Fukuoka | 812-8582 | Japan |
|
| Kumamoto University Hospital | Recruiting | Kumamoto | 860-8556 | Japan |
|
| National Hospital Organization Okayama Medical Center | Recruiting | Okayama | 701-1192 | Japan |
|
| Osaka Red Cross Hospital | Recruiting | Osaka | 543-8555 | Japan |
|
| Yamagata University Hospital | Recruiting | Yamagata | 990-9585 | Japan |
|
| Radboudumc | Recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
|
| Maastricht UMC+ | Recruiting | Maastricht | Limburg | 6229 HX | Netherlands |
|
| Amsterdam UMC, locatie VUmc | Recruiting | Amsterdam | North Holland | 1081 HV | Netherlands |
|
| Universitair Medisch Centrum Utrecht | Recruiting | Utrecht | 3584 CX | Netherlands |
|
| Sykehusapoteket Ull | Recruiting | Oslo | 0450 | Norway |
|
| Centrum Onkologii Ziemi Lubelskiej | Recruiting | Lublin | Lublin Voivodeship | 20-090 | Poland |
|
| Uniwersyteckie Centrum Kliniczne | Recruiting | Gdansk | Pomeranian Voivodeship | 80-214 | Poland |
|
| Local Institution - 0084 | Not yet recruiting | Katowice | 40-519 | Poland |
|
| Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi | Recruiting | Lodz | Łódź Voivodeship | 93-513 | Poland |
|
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE | Recruiting | Porto | 4200-072 | Portugal |
|
| Fundeni Clinical Institute | Recruiting | Bucharest | Bucharest | 022328 | Romania |
|
| Institutul Regional de Oncologie | Recruiting | Iași | 700483 | Romania |
|
| Local Institution - 0178 | Not yet recruiting | Riyadh | 12713 | Saudi Arabia |
|
| National University Hospital | Recruiting | Singapore | Central Singapore | 119074 | Singapore |
|
| Local Institution - 0181 | Withdrawn | Singapore | Central Singapore | 169608 | Singapore |
| Seoul National University Hospital | Recruiting | Seoul | Seoul-teukbyeolsi [Seoul] | 03080 | South Korea |
|
| Asan Medical Center | Recruiting | Seoul | Seoul-teukbyeolsi [Seoul] | 05505 | South Korea |
|
| Samsung Medical Center | Recruiting | Seoul | Seoul-teukbyeolsi [Seoul] | 06351 | South Korea |
|
| The Catholic Univ. of Korea Seoul St. Mary's Hospital | Recruiting | Seoul | Seoul-teukbyeolsi [Seoul] | 06591 | South Korea |
|
| CHUS - Hospital Clinico Universitario | Recruiting | Santiago de Compostela | A Coruña [La Coruña] | 15706 | Spain |
|
| Hospital Universitari Son Espases | Recruiting | Palma | Balears [Baleares] | 07120 | Spain |
|
| Institut Catalan d Oncologia (ICO) - Badalona | Recruiting | Badalona | Barcelona [Barcelona] | 08916 | Spain |
|
| Clinica Universidad de Navarra | Recruiting | Pamplona | Navarre | 31008 | Spain |
|
| Hospital Universitario Virgen Nieves | Recruiting | Granada | 18012 | Spain |
|
| Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca | Recruiting | Salamanca | 37007 | Spain |
|
| Sahlgrenska Universitetssjukhuset | Recruiting | Gothenburg | Västra Götalands Län [se-14] | 413 45 | Sweden |
|
| Karolinska Universitetssjukhuset Huddinge | Recruiting | Huddinge | 141 86 | Sweden |
|
| Skånes Universitetssjukhus Lund | Recruiting | Lund | 222 42 | Sweden |
|
| Inselspital Bern | Recruiting | Bern | Canton of Bern | 3010 | Switzerland |
|
| Cantonal Hospital St.Gallen | Recruiting | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
|
| National Taiwan University Cancer Center (NTUCC) | Recruiting | Taipei City | Taipei | 106 | Taiwan |
|
| China Medical University Hospital | Recruiting | Taichung | 404332 | Taiwan |
|
| National Taiwan University Hospital | Recruiting | Taipei | 10002 | Taiwan |
|
| Taipei Veterans General Hospital | Recruiting | Taipei | 11217 | Taiwan |
|
| Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi | Recruiting | Ankara | 06200 | Turkey (Türkiye) |
|
| Addenbrooke's Hospital | Recruiting | Cambridge | Cambridgeshire | CB2 2QQ | United Kingdom |
|
| University College London Hospital | Recruiting | London | London, City of | NW1 2PG | United Kingdom |
|
| Churchill Hospital | Recruiting | Oxford | Oxfordshire | OX3 7LE | United Kingdom |
|
| The Christie NHS Foundation Trust | Recruiting | Manchester | M20 4BX | United Kingdom |
|
| Freeman Hospital | Recruiting | Newcastle upon Tyne | NE7 7DN | United Kingdom |
|
| Sheffield Teaching Hospitals NHS Foundation Trust | Recruiting | Sheffield | S10 2JF | United Kingdom |
|
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| C556306 | daratumumab |
| C467566 | pomalidomide |
| D003907 | Dexamethasone |
| C524865 | carfilzomib |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
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