Multiple Myeloma Clinical Trial
Official title:
A Phase 3, Two-stage, Randomized, Multi-center, Controlled, Open-label Study Comparing Iberdomide Maintenance to Lenalidomide Maintenance Therapy After Autologous Stem Cell Transplantation (ASCT) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) (EXCALIBER-Maintenance)
The purpose of this study is to compare the effectiveness of iberdomide maintenance to lenalidomide maintenance therapy after autologous stem cell transplantation (ASCT) in participants with newly diagnosed multiple myeloma (NDMM).
| Status | Recruiting |
| Enrollment | 1216 |
| Est. completion date | January 1, 2036 |
| Est. primary completion date | March 15, 2029 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria - Confirmed diagnosis of symptomatic multiple myeloma (MM). - Eastern Cooperative Oncology Group performance status (ECOG) score of 0, 1, or 2. - Received 3 to 6 cycles of an induction therapy that includes a proteasome inhibitor (PI) and immunomodulatory (IMiD) [eg, bortezomib thalidomide and dexamethasone (VTd), lenalidomide, bortezomib and dexamethasone (RVd)] with or without a CD38 monoclonal antibody, or Velcade® (bortezomib), cyclophosphamide, dexamethasone (VCd), and followed by a single or tandem autologous stem cell transplantation (ASCT). Post-stem cell transplant consolidation is permitted. - Participants within 12 months from initiation of induction therapy who achieved at least a partial response (PR) after autologous stem cell transplantation (ASCT) with or without consolidation, according to International Myeloma Working Group (IMWG 2016) criteria. Exclusion Criteria - Progressive disease or clinical relapse (as defined by IMWG response criteria) following ASCT with or without consolidation or is not responsive to primary therapy. - Smoldering myeloma, solitary plasmacytoma or nonsecretory myeloma. - Known central nervous system/meningeal involvement of MM. - Prior history of malignancies, other than MM, unless the participant has been free of the disease for = 5 years. - Other protocol-defined Inclusion/Exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0183 | Ciudad Autonoma Buenos Aires | Caba |
| Argentina | Local Institution - 0227 | Ciudad Autonoma Buenos Aires | Caba |
| Argentina | Local Institution - 0182 | Córdoba | |
| Argentina | Local Institution - 0259 | Mar del Plata | B |
| Argentina | Local Institution - 0267 | Pilar | B |
| Australia | Royal Adelaide Hospital | Adelaide | South Australia |
| Australia | Box Hill Hospital | Box Hill | Victoria |
| Australia | Local Institution - 0078 | Clayton | Victoria |
| Australia | Local Institution - 0244 | Waratah | New South Wales |
| Austria | Ordensklinikum Linz Elisabethinen | Linz | |
| Austria | Universitätsklinikum St. Pölten | St. Pölten | |
| Austria | Hanusch-Krankenhaus | Vienna | |
| Austria | Medizinische Universitaet Wien - Universitaetsklinik fuer Augenheilkunde und Optometrie | Vienna | |
| Belgium | Local Institution - 0035 | Charleroi | WHT |
| Belgium | Local Institution - 0048 | Kortrijk | |
| Brazil | Local Institution - 0190 | Barretos | |
| Brazil | Local Institution - 0245 | Curitiba | PR |
| Brazil | Local Institution - 0214 | Niterói | RJ |
| Brazil | Local Institution - 0083 | Porto Alegre | |
| Brazil | Local Institution - 0081 | Ribeirão Preto | SP |
| Brazil | Local Institution - 0082 | Rio de Janeiro | RJ |
| Brazil | Local Institution - 0096 | Rio de Janeiro | |
| Brazil | Local Institution - 0098 | Salvador | |
| Brazil | Local Institution - 0277 | Sao Paulo | SP |
| Brazil | Local Institution - 0194 | São Paulo | SP |
| Brazil | Local Institution - 0241 | São Paulo | SP |
| Canada | Cross Cancer Institute | Edmonton | Alberta |
| Canada | Local Institution - 0307 | Montreal | Quebec |
| Canada | The Ottawa Hospital - General Campus | Ottawa | Ontario |
| Canada | CHUQ - The Hôtel-Dieu de Québec | Quebec | |
| Chile | Fundación Arturo López Pérez | Santiago | |
| Chile | Instituto Oncolologico del Sur | Temuco | |
| Chile | Clinica Alemana - Vitacura | Vitacura | |
| China | Peking University People's Hospital | Beijing | |
| China | The Fifth Medical Center of People's Liberation Army General Hospital | Beijing | Beijing |
| China | Local Institution - 0100 | Beijing Shi | Beijing |
| China | Local Institution - 0212 | Binzhou | |
| China | Local Institution - 0091 | Changchun | Jilin |
| China | Local Institution - 0234 | Changsha | |
| China | Local Institution - 0282 | Changsha | Hunan |
| China | Xiangya Hospital, Central South University | Changsha | Hunan |
| China | Local Institution - 0242 | Chongqing | Chongqing |
| China | Local Institution - 0273 | Fuzhou | |
| China | Local Institution - 0079 | Guangzhou | Guangdong |
| China | Local Institution - 0304 | Guangzhou | Guangdong |
| China | Guangdong Provincial People's Hospital | Guangzhou Shi | Guangdong |
| China | The First Affiliated Hospital - Zhejiang University School of Medicine | Hangzhou | Zhejiang |
| China | Anhui Provincial Hospital | Hefei | AH |
| China | Local Institution - 0240 | Jinan | Shandong |
| China | The First Affiliated Hospital of Nanchang University - Donghu District | Nanchang | Jiangxi |
| China | Local Institution - 0231 | Nanjing | |
| China | Local Institution - 0266 | Nanjing | Jiangsu |
| China | Local Institution - 0077 | Qingdao | |
| China | Local Institution - 0271 | Shanghai | Shanghai |
| China | Ruijin Hospital Affiliated to The Shanghai Jiao Tong University Medical School | Shanghai | |
| China | Local Institution - 0094 | Shenyang | Liaoning |
| China | Local Institution - 0256 | Shenzhen | Guangdong |
| China | Local Institution - 0305 | Suzhou Shi | |
| China | Tianjin Medical University Cancer Institute and Hospital | Tianjin | Tianjin |
| China | Wenzhou Medical University - The First Affiliated Hospital | Wenzhou Shi | |
| China | Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology | Wuhan | |
| China | Local Institution - 0248 | Wuhan Shi | |
| China | Local Institution - 0265 | Xi'an City | Shaanxi |
| China | Local Institution - 0239 | Xuzhou | Jiangsu |
| China | Henan Cancer Hospital | Zhengzhou City | Henan |
| Colombia | Local Institution - 0211 | Bogota | |
| Colombia | Local Institution - 0217 | Bogota | |
| Colombia | Local Institution - 0101 | Floridablanca | |
| Colombia | Local Institution - 0179 | Medellin | |
| Colombia | Local Institution - 0302 | Monteria | Cordoba |
| Colombia | Local Institution - 0093 | Valledupar | |
| Czechia | Fakultní Nemocnice Brno | Brno | |
| Czechia | Fakultní Nemocnice Olomouc | Olomouc | |
| Czechia | Fakultní nemocnice Královské Vinohrady | Prague | |
| Czechia | Všeobecná fakultní nemocnice v Praze | Praha | |
| Denmark | Odense Universitetshospital | Odense | |
| Finland | Helsingin Yliopistollinen Sairaala (HUS) - Syopakeskus (Comprehensive Cancer Center) | Helsinki | |
| Finland | Kuopio University Hospital | Kuopio | |
| France | CHU Hôpital Sud | Amiens Cedex 1 | |
| France | Institut d'Hématologie de Basse-Normandie (IHBN) | Caen | |
| France | Local Institution - 0050 | Creteil | |
| France | Local Institution - 0236 | La Roche Sur Yon | |
| France | Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez | Lille | |
| France | CHU Limoges - Hôpital Dupuytren | Limoges | |
| France | Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hotel-Dieu | Nantes | |
| France | Hopital Pitie-Salpetriere | Paris | |
| France | Local Institution - 0219 | Paris | |
| France | Local Institution - 0066 | Pierre Benite | |
| France | Institut Universitaire du Cancer de Toulouse - Oncopole | Toulouse | |
| Germany | Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF) | Berlin | BE |
| Germany | Local Institution - 0298 | Erlangen | BY |
| Germany | Local Institution - 0297 | Hamburg | |
| Germany | St. Barbara-Klinik Hamm-Heessen GmbH | Hamm | |
| Germany | Universitätsklinikum Jena | Jena | |
| Germany | Universitätsklinikum Tübingen | Tübingen | |
| Germany | Universitätsklinikum Ulm | Ulm | BW |
| Greece | Alexandra General Hospital of Athens | Athens | |
| Greece | Local Institution - 0185 | Athina | I |
| Greece | Local Institution - 0290 | Larisa | |
| Greece | Local Institution - 0097 | Rio | G |
| Greece | "General Hospital of Thessaloniki ""G. Papanikolaou""" | Thessaloniki | B |
| Greece | Theageneio Cancer Hospital of Thessaloniki | Thessaloniki | |
| Hong Kong | Local Institution - 0250 | Hong Kong | HK |
| India | Local Institution - 0110 | Bangalore | Karnataka |
| India | Sparsh Hospitals & Critical Care | Bhubaneswar | Odisha |
| India | Local Institution - 0128 | Chandigarh | CH |
| India | Local Institution - 0109 | Cochin | KL |
| India | Local Institution - 0200 | Kolhapur | MH |
| India | Local Institution - 0125 | Kolkata | WB |
| India | Local Institution - 0152 | Nagpur | MH |
| India | Local Institution - 0135 | Navi Mumbai | |
| India | Local Institution - 0123 | Pune | MH |
| India | Local Institution - 0142 | Pune | MH |
| Israel | Local Institution - 0057 | Ashdod | |
| Israel | Assaf Harofeh Medical Center | Beer Ya'Aqov | |
| Israel | Hillel Yaffe Medical Center | Hadera | |
| Israel | Rambam Medical Center | Haifa | |
| Israel | Hadassah University Medical Center | Jerusalem | |
| Israel | Shaare Zedek Medical Center | Jerusalem | |
| Israel | Local Institution - 0108 | Petah Tikva | |
| Israel | Local Institution - 0131 | Ramat Gan | |
| Israel | Local Institution - 0136 | Tel Aviv-Yafo | |
| Italy | Azienda Ospedaliero Universitaria Policlinico G. Rodolico San Marco - Ospedale San Marco | Catania | CT |
| Italy | Local Institution - 0306 | Firenze | FL |
| Italy | Local Institution - 0115 | Genova | GE |
| Italy | Local Institution - 0071 | Milano | MI |
| Italy | Local Institution - 0188 | Milano | MI |
| Italy | "Azienda Ospedaliera Universitaria ""Federico II""" | Naples | |
| Italy | Local Institution - 0278 | Pavia | |
| Italy | Azienda Ospedaliero Universitaria Pisana - Ospedale Santa Chiara | Pisa | PI |
| Italy | Fondazione Policlinico Universitario Agostino Gemelli | Roma | RM |
| Italy | Local Institution - 0065 | Rome | |
| Italy | Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino - Ospedale Molinette | Torino | TO |
| Japan | Chiba University Hospital | Chiba-shi | |
| Japan | Local Institution - 0118 | Gifu-Shi | |
| Japan | Local Institution - 0133 | Higashiibaraki-Gun | |
| Japan | Local Institution - 0112 | Hiroshima-shi | |
| Japan | Tokai University Hospital | Isehara-shi | |
| Japan | Kagoshima University Hospital | Kagoshima-Shi | |
| Japan | Shonan Kamakura General Hospital | Kamakura-Shi | Kanagawa |
| Japan | Kanazawa University Hospital | Kanazawa-shi | |
| Japan | Local Institution - 0134 | Kobe-Shi | |
| Japan | The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JFCR) | Koto-Ku | |
| Japan | Kumamoto University Hospital | Kumamoto-shi | Kumamoto |
| Japan | Gunma University Hospital | Maebashi-Shi | |
| Japan | The Jikei University Hospital | Minato-ku | |
| Japan | The Japanese Red Cross Nagasaki Genbaku Hospital | Nagasaki-Shi | |
| Japan | Nagoya City University Hospital | Nagoya-Shi | |
| Japan | Local Institution - 0268 | Osakasayama-shi | |
| Japan | Jichi Medical University Saitama Medical Center | Saitama-shi | |
| Japan | Local Institution - 0105 | Sapporo-shi | |
| Japan | National Hospital Organization Sendai Medical Center | Sendai-shi | |
| Japan | Local Institution - 0106 | Shibukawa-shi | |
| Japan | Japanese Red Cross Medical Center | Shibuya-ku | |
| Japan | Local Institution - 0130 | Shizuoka-shi | |
| Korea, Republic of | Pusan National University Hospital | Busan | |
| Korea, Republic of | National Cancer Center | Goyang-si | |
| Korea, Republic of | Local Institution - 0293 | Seongnam-si, Gyeonggi-do | |
| Korea, Republic of | Local Institution - 0295 | Seoul | |
| Korea, Republic of | Samsung Medical Center | Seoul | |
| Korea, Republic of | Ulsan University Hospital (UUH) | Ulsan | |
| Mexico | Local Institution - 0127 | Mexico | CMX |
| Mexico | Local Institution - 0107 | Mexico city | |
| Mexico | Local Institution - 0283 | Monterrey | NL |
| Mexico | Local Institution - 0146 | Toluca De Lerdo | MEX |
| Netherlands | Local Institution - 0129 | Amsterdam | NH |
| Poland | Local Institution - 0149 | Bydgoszcz | KP |
| Poland | Local Institution - 0195 | Gdansk | PM |
| Poland | Local Institution - 0252 | Gliwice | |
| Poland | Local Institution - 0039 | Katowice | |
| Poland | Local Institution - 0059 | Lodz | LD |
| Poland | Local Institution - 0044 | Lublin | |
| Poland | Local Institution - 0119 | Warsaw | |
| Portugal | Unidade Local de Saude Braga | Braga | |
| Portugal | Local Institution - 0151 | Coimbra | |
| Portugal | Instituto Português Oncologia do Porto Francisco Gentil, EPE | Porto | |
| Romania | Institutul Clinic Fundeni | Bucuresti | B |
| Romania | "Institutul Oncologic ""Prof. Dr. Ion Chiricuta"" Cluj Napoca" | Cluj-Napoca | Jud. Cluj |
| Romania | "Institutul Oncologic ""Prof. Dr. Ion Chiricuta"" Cluj Napoca" | Cluj-Napoca | |
| Romania | Local Institution - 0043 | Craiova | Dolj |
| Romania | Institutul Regional de Oncologie Ia?i | Iasi | IS |
| Singapore | Local Institution - 0138 | Singapore | |
| Singapore | Local Institution - 0187 | Singapore | |
| Spain | Hospital Universitari Germans Trias i Pujol | Badalona | |
| Spain | Local Institution - 0226 | Barcelona | B |
| Spain | Hospital San Pedro de Alcántara | Cáceres | CC |
| Spain | Hospital Universitario de Gran Canaria Doctor Negrín | Las Palmas de Gran Canaria | Las Palmas |
| Spain | Hospital Universitario Virgen Arrixaca | Murcia | MU |
| Spain | Hospital Universitario Central de Asturias | Oviedo | Asturias |
| Spain | Hospital Universitari Son Espases | Palma de Mallorca | |
| Spain | Local Institution - 0163 | Pamplona | |
| Spain | Hospital Universitari i Politècnic La Fe | Valencia | VC |
| Sweden | Södra Älvsborgs Sjukhus | Borås | |
| Sweden | Local Institution - 0171 | Luleå | BD |
| Sweden | Local Institution - 0291 | Uddevalla | |
| Switzerland | Local Institution - 0168 | Aarau 1 | |
| Taiwan | Local Institution - 0153 | Kao-Hsiung | |
| Taiwan | E-DA Cancer Hospital | Kaohsiung | |
| Taiwan | Far Eastern Memorial Hospital | New Taipei City | |
| Taiwan | Local Institution - 0165 | Tainan | |
| Taiwan | Local Institution - 0292 | Taipei | |
| Taiwan | Local Institution - 0289 | Taoyuan | |
| Turkey | Local Institution - 0167 | Ankara | |
| Turkey | Local Institution - 0287 | Cankaya | |
| Turkey | Local Institution - 0052 | Edirne | |
| Turkey | Local Institution - 0068 | Istanbul | |
| Turkey | Local Institution - 0073 | Izmir | |
| Turkey | Local Institution - 0158 | Izmir | |
| Turkey | Local Institution - 0024 | Kayseri | |
| Turkey | Local Institution - 0032 | Yenimahalle | |
| United Kingdom | NHS Grampian - Aberdeen Royal Infirmary | Aberdeen | ABD |
| United Kingdom | Local Institution - 0162 | Bournemouth | DOR |
| United Kingdom | University Hospitals of Derby and Burton NHS Foundation Trust - Royal Derby Hospital | Derby | DBY |
| United Kingdom | NHS Lothian - Western General Hospital | Edinburgh | |
| United Kingdom | Barts Health NHS Trust - St Bartholomew's Hospital | London | |
| United Kingdom | GenesisCare-Oxford | Oxford | |
| United Kingdom | Local Institution - 0284 | Portsmouth | HAM |
| United Kingdom | University Hospitals of North Midlands NHS Trust (UHNM) - Royal Stoke University Hospital | Stoke-on-Trent | Staffordshire |
| United Kingdom | GenesisCare -Windosr | Windsor | Berkshire |
| United States | University of Michigan - Rogel Cancer Center | Ann Arbor | Michigan |
| United States | University Cancer Blood Ctr | Athens | Georgia |
| United States | The Winship Cancer Institute of Emory University | Atlanta | Georgia |
| United States | Augusta University - Georgia Cancer Center | Augusta | Georgia |
| United States | Rocky Mountain Cancer Centers | Aurora | Colorado |
| United States | Novant Health Cancer Institute - Elizabeth | Charlotte | North Carolina |
| United States | The University of Chicago Medical Center - Duchossois Center for Advanced Medicine | Chicago | Illinois |
| United States | Oncology Hematology Care, Inc. - Cincinnati - Galbraith Rd | Cincinnati | Ohio |
| United States | Cleveland Clinic | Cleveland | Ohio |
| United States | Cleveland Clinic - Fairview Hospital - Cancer Center (Moll Cancer Center) | Cleveland | Ohio |
| United States | Maryland Oncology Hematology, PA- Clinton | Clinton | Maryland |
| United States | Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas |
| United States | UT Southwestern-Harold C. Simmons Cancer Center | Dallas | Texas |
| United States | Henry Ford Health System - The Henry Ford Cancer Institute (HFCI) - Detroit | Detroit | Michigan |
| United States | Duke University Hospital | Durham | North Carolina |
| United States | Willamette Valley Cancer Institute | Eugene | Oregon |
| United States | West Cancer Center | Germantown | Tennessee |
| United States | Cancer & Hematology Centers of Western Michigan (CHCWM) | Grand Rapids | Michigan |
| United States | Hattiesburg Clinic - Hematology & Oncology | Hattiesburg | Mississippi |
| United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Mayo Clinic Florida | Jacksonville | Florida |
| United States | Midwest Oncology Associates - Kansas City | Kansas City | Missouri |
| United States | Cleveland Clinic - Hillcrest Hospital - Hillcrest Cancer Center | Mayfield Heights | Ohio |
| United States | Perlmutter Cancer Center at NYU Langone Hematology Oncology Associates-Mineola | Mineola | New York |
| United States | Morristown Medical Center | Morristown | New Jersey |
| United States | Tennessee Oncology | Nashville | Tennessee |
| United States | Columbia University Medical Center - Herbert Irving Pavilion Location | New York | New York |
| United States | NYU Langone Health | New York | New York |
| United States | Local Institution - 0011 | Philadelphia | Pennsylvania |
| United States | Thomas Jefferson University Hospital | Philadelphia | Pennsylvania |
| United States | University of Pittsburgh - Hillman Cancer Center | Pittsburgh | Pennsylvania |
| United States | Local Institution - 0303 | Rochester | Minnesota |
| United States | Local Institution - 0192 | Tampa | Florida |
| United States | Local Institution - 0308 | Tampa | Florida |
| United States | Toledo Clinic Cancer Centers | Toledo | Ohio |
| United States | Clinical Research Alliance | Westbury | New York |
| United States | Cleveland Clinic | Weston | Florida |
| United States | University of Kansas Cancer Center - The Richard and Annette Bloch Cancer Care Pavilion | Westwood | Kansas |
| United States | Novant Health Cancer Institute Hematology - Forsyth | Winston-Salem | North Carolina |
| United States | Wooster Milltown Specialty and Surgery Center | Wooster | Ohio |
| United States | Local Institution - 0279 | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Portugal, Romania, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free survival (PFS) | Up to 6 years | ||
| Secondary | Achieving minimal residual disease (MRD) negativity in participants with complete response (CR) or better at 12 (± 3) months of maintenance treatment | Up to 6 years | ||
| Secondary | Overall Survival | Up to 12 years | ||
| Secondary | Recommended iberdomide dose for Stage 2 | Up to 1 year | ||
| Secondary | Area under the iberdomide plasma concentration-time curve from time zero to tau | Up to 1 year | ||
| Secondary | Area under the iberdomide plasma concentration-time curve within a dosing interval AUC (TAU) | Up to 1 year | ||
| Secondary | Maximum iberdomide concentration (Cmax) | Up to 1 year | ||
| Secondary | Time to maximum iberdomide plasma concentration (Tmax) | Up to 1 year | ||
| Secondary | Number of participants with adverse events (AEs) | Up to 6 years | ||
| Secondary | Progression-free survival on next line of treatment (PFS2) | Up to 6 years | ||
| Secondary | Achieving MRD negativity in participants with CR or better at any time after the date of randomization | Up to 6 years | ||
| Secondary | Conversion from MRD positive to MRD negative in participants with CR or better | Up to 6 years | ||
| Secondary | Achievement of CR or better and maintaining MRD-negative status in 2 bone marrow aspirate assessments that are a minimum of 6 months or 1 year apart, without any examination showing MRD positive status in between assessments | Up to 6 years | ||
| Secondary | Time to progression (TTP) | Up to 6 years | ||
| Secondary | Time to next treatment (TTNT) | Up to 6 years | ||
| Secondary | Best response achieved prior to progressive disease (PD) | Up to 6 years | ||
| Secondary | Patient-reported health-related quality of life (HRQoL) outcomes and multiple myeloma-related symptoms as measured by the European Organization for Research and Treatment of Cancer [EORTC] Quality of Life C30 questionnaire (QLQ-C30) | Up to 6 years | ||
| Secondary | Patient-reported HRQoL outcomes and multiple myeloma-related symptoms as measured by the EORTC Quality of Life Multiple Myeloma Module (QLQ-MY20) | Up to 6 years |
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