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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-509472-42 | Registry Identifier | EU Trial Number | |
| U1111-1281-8227 | Registry Identifier | WHO |
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Business objectives have changed
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The purpose of this study is to evaluate the efficacy and safety of alnuctamab compared to standard of care regimens in participants with relapsed or refractory multiple myeloma (RRMM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Alnuctamab | Experimental |
| |
| Arm B: Standard of Care Regimens | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alnuctamab | Drug | Specified dose on specified days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Up to 5 years | |
| Overall response (OR) | Up to 5 years | |
| Complete response (CR) or better |
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Inclusion Criteria
Participant is willing and able to adhere to the study visit schedule and other protocol requirements including bone marrow aspirations and/or biopsies and hospitalization during the first cycle.
Documented diagnosis of multiple myeloma (MM), and must:.
i) Received at least 1 but not more than 3 prior lines of anti-myeloma therapy.
ii) Received prior treatment with lenalidomide and an anti-CD38 monoclonal antibody (for at least 2 consecutive cycles).
iii) Achieved minimal response (MR) or better to at least 1 prior anti-myeloma therapy.
iv) Documented PD during or after their last anti-myeloma therapy or failure to achieve response.
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0151 | Birmingham | Alabama | 35294 | United States | ||
| Local Institution - 0088 |
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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/disclosurecommitment.html
See Plan Description
See Plan Description
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| Pomalidomide | Drug | Specified dose on specified days |
|
|
| Daratumumab | Drug | Specified dose on specified days |
|
|
| Elotuzumab | Drug | Specified dose on specified days |
|
|
| Carfilzomib | Drug | Specified dose on specified days |
|
|
| Dexamethasone | Drug | Specified dose on specified days |
|
| Up to 5 years |
| Very good partial response (VGPR) or better | Up to 5 years |
| Time to response (TTR) | Up to 5 years |
| Duration of response (DOR) | Up to 5 years |
| Time to progression (TTP) | Up to 5 years |
| Time to next treatment (TTNT) | Up to 5 years |
| Progression-free survival 2 (PFS2) | Up to 5 years |
| Restricted mean DOR (RMDOR) | Up to 5 years |
| Minimal residual disease (MRD) negativity rate | Up to 5 years |
| Incidence of adverse events (AEs) | Up to 5 years |
| Incidence of serious adverse events (SAEs) | Up to 5 years |
| Change from baseline in subscale scores of European organization for research and treatment of cancer - quality of life core 30 (EORTC QLQ-C30) | Up to 5 years |
| Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20) | Up to 5 years |
| Los Angeles |
| California |
| 90095 |
| United States |
| Local Institution - 0358 | Stanford | California | 94305 | United States |
| Local Institution - 0355 | New Haven | Connecticut | 06520 | United States |
| Local Institution - 0434 | Washington D.C. | District of Columbia | 20007 | United States |
| Local Institution - 0433 | Wichita | Kansas | 67214 | United States |
| Local Institution - 0439 | Saint Matthews | Kentucky | 40207 | United States |
| Local Institution - 0323 | New Orleans | Louisiana | 70112 | United States |
| Local Institution - 0324 | Baltimore | Maryland | 21218 | United States |
| Local Institution - 0441 | Bethesda | Maryland | 20889 | United States |
| Local Institution - 0435 | Billings | Montana | 59102 | United States |
| Local Institution - 0157 | Hackensack | New Jersey | 07601 | United States |
| Local Institution - 0359 | Summit | New Jersey | 07901 | United States |
| Local Institution - 0430 | Lake Success | New York | 11042 | United States |
| Local Institution - 0396 | New York | New York | 10065 | United States |
| Local Institution - 0306 | Cincinnati | Ohio | 45220 | United States |
| Local Institution - 0199 | Cleveland | Ohio | 44109 | United States |
| Local Institution - 0437 | Pittsburgh | Pennsylvania | 15224 | United States |
| Local Institution - 0352 | Providence | Rhode Island | 02903 | United States |
| Local Institution - 0420 | Watertown | South Dakota | 57201 | United States |
| Local Institution - 0168 | Dallas | Texas | 75390-88520 | United States |
| Local Institution - 0405 | Seattle | Washington | 98109 | United States |
| Local Institution - 0001 | La Plata | Buenos Aires | 1900 | Argentina |
| Local Institution - 0262 | Pilar | Buenos Aires | 1629 | Argentina |
| Local Institution - 0222 | San Juan Bautista | Buenos Aires | 1888 | Argentina |
| Local Institution - 0002 | Buenos Aires | Buenos Aires F.D. | C1118AAT | Argentina |
| Local Institution - 0260 | Liverpool | New South Wales | 2170 | Australia |
| Local Institution - 0246 | Macquarie University | New South Wales | 2109 | Australia |
| Local Institution - 0022 | Waratah | New South Wales | 2298 | Australia |
| Local Institution - 0397 | Brisbane | Queensland | 4120 | Australia |
| Local Institution - 0021 | Box Hill | Victoria | 3128 | Australia |
| Local Institution - 0019 | Clayton | Victoria | 3168 | Australia |
| Local Institution - 0018 | Melbourne | Victoria | 3004 | Australia |
| Local Institution - 0003 | Melbourne | Victoria | 3065 | Australia |
| Local Institution - 0333 | Sankt Pölten | Lower Austria | 3100 | Austria |
| Local Institution - 0337 | Innsbruck | Tyrol | 6020 | Austria |
| Local Institution - 0334 | Salzburg | 5020 | Austria |
| Local Institution - 0332 | Vienna | 1090 | Austria |
| Local Institution - 0284 | Brasschaat | Antwerpen | 2930 | Belgium |
| Local Institution - 0280 | Verviers | Liège | 4800 | Belgium |
| Local Institution - 0279 | Yvoir | Namur | 5530 | Belgium |
| Local Institution - 0286 | Leuven | Vlaams-Brabant | 3000 | Belgium |
| Local Institution - 0274 | Belo Horizonte | Minas Gerais | 30110-022 | Brazil |
| Local Institution - 0351 | Natal | Rio Grande do Norte | 59025050 | Brazil |
| Local Institution - 0369 | São Paulo | São Paulo | 01509-010 | Brazil |
| Local Institution - 0291 | Rio de Janeiro | 22250-905 | Brazil |
| Local Institution - 0211 | São Paulo | 05652-900 | Brazil |
| Local Institution - 0417 | Calgary | Alberta | T2N 4N2 | Canada |
| Local Institution - 0423 | Edmonton | Alberta | T6G1Z2 | Canada |
| Local Institution - 0402 | London | Ontario | N6A 5W9 | Canada |
| Local Institution - 0395 | Toronto | Ontario | M5G 2M9 | Canada |
| Local Institution - 0031 | Montreal | Quebec | H1T 2M4 | Canada |
| Local Institution - 0098 | Montreal | Quebec | H2X 1P1 | Canada |
| Local Institution - 0027 | Santiago | Metropolitana de Santiago | 7580206 | Chile |
| Local Institution - 0030 | Santiago | Santiago Metropolitan | 7500921 | Chile |
| Local Institution - 0026 | Santiago | Santiago Metropolitan | 7620002 | Chile |
| Local Institution - 0029 | Santiago | Santiago Metropolitan | 7650568 | Chile |
| Local Institution - 0413 | Beijing | Beijing Municipality | 0 | China |
| Local Institution - 0230 | Beijing | Beijing Municipality | 100020 | China |
| Local Institution - 0040 | Beijing | Beijing Municipality | 100034 | China |
| Local Institution - 0366 | Changping | Beijing Municipality | 102200 | China |
| Local Institution - 0057 | Chongqing | Chongqing Municipality | 400016 | China |
| Local Institution - 0066 | Guangzhou | Guangdong | 510060 | China |
| Local Institution - 0080 | Guangzhou | Guangdong | 510120 | China |
| Local Institution - 0226 | Guangzhou | Guangdong | 510515 | China |
| Local Institution - 0368 | Shenzhen | Guangdong | 518036 | China |
| Local Institution - 0365 | Baoding | Hebei | 071030 | China |
| Local Institution - 0082 | Shijiazhuang | Hebei | 050051 | China |
| Local Institution - 0041 | Zhengzhou | Henan | 450008 | China |
| Local Institution - 0075 | Wuhan | Hubei | 430030 | China |
| Local Institution - 0062 | Changsha | Hunan | 410011 | China |
| Local Institution - 0053 | Changsha | Hunan | 410013 | China |
| Local Institution - 0055 | Nanjing | Jiangsu | 210000 | China |
| Local Institution - 0067 | Suzhou | Jiangsu | 215006 | China |
| Local Institution - 0377 | Xuzhou | Jiangsu | 221006 | China |
| Local Institution - 0044 | Shenyang | Liaoning | 110004 | China |
| Local Institution - 0072 | Xi'an | Shaanxi | 710004 | China |
| Local Institution - 0077 | Jinan | Shandong | 250014 | China |
| Local Institution - 0083 | Jinan | Shandong | 250117 | China |
| Local Institution - 0273 | Shanghai | Shanghai Municipality | 200032 | China |
| Local Institution - 0421 | Shanghai | Shanghai Municipality | 200081 | China |
| Local Institution - 0245 | Taiyuan | Shanxi | 030000 | China |
| Local Institution - 0056 | Tianjin | Tianjin Municipality | 300052 | China |
| Local Institution - 0422 | Tianjin | Tianjin Municipality | 300308 | China |
| Local Institution - 0070 | Hangzhou | Zhejiang | 310003 | China |
| Local Institution - 0203 | Hangzhou | Zhejiang | 310003 | China |
| Local Institution - 0367 | Qingdao | 266011 | China |
| Local Institution - 0013 | Brno | Brno-město | 625 00 | Czechia |
| Local Institution - 0247 | Olomouc | Olomouc Region | 779 00 | Czechia |
| Local Institution - 0012 | Prague | 12808 | Czechia |
| Local Institution - 0118 | Toulouse | Haute-Garonne | 31100 | France |
| Local Institution - 0225 | Montpellier | Languedoc-Roussillon | 34295 | France |
| Local Institution - 0224 | Vandœuvre-lès-Nancy | Lorraine | 54511 | France |
| Local Institution - 0084 | Lille | Nord | 59000 | France |
| Local Institution - 0085 | Nantes | Pays de la Loire Region | 44000 | France |
| Local Institution - 0192 | Pierre-Bénite | Rhône | 69310 | France |
| Local Institution - 0331 | Heidelberg | Baden-Wurttemberg | 69120 | Germany |
| Local Institution - 0330 | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Local Institution - 0335 | Dresden | Saxony | 01307 | Germany |
| Local Institution - 0329 | Leipzig | Saxony | 04103 | Germany |
| Local Institution - 0339 | Hamburg | 22763 | Germany |
| Local Institution - 0004 | Athens | Attikí | 115 28 | Greece |
| Local Institution - 0136 | Chaïdári | Attikí | 12462 | Greece |
| Local Institution - 0103 | Nyíregyháza | Szabolcs-Szatmár-Bereg | 4400 | Hungary |
| Local Institution - 0108 | Szombathely | Vas County | 9700 | Hungary |
| Local Institution - 0104 | Budapest | 1088 | Hungary |
| Local Institution - 0105 | Budapest | 1097 | Hungary |
| Local Institution - 0370 | Visakhapatnam | Andhra Pradesh | 530040 | India |
| Local Institution - 0362 | Gurugram | Haryana | 122011 | India |
| Local Institution - 0403 | Bangalore | Karnataka | 560092 | India |
| Local Institution - 0399 | Lucknow | Uttar Pradesh | 226014 | India |
| Local Institution - 0398 | Kolkata | West Bengal | 700094 | India |
| Local Institution - 0281 | Cork | T12 E8YV | Ireland |
| Local Institution - 0371 | Dublin | D04 N2E0 | Ireland |
| Local Institution - 0285 | Dublin | D08 E9P6 | Ireland |
| Local Institution - 0269 | Limerick | V94 F858 | Ireland |
| Local Institution - 0096 | Meldola | Emilia-Romagna | 47014 | Italy |
| Local Institution - 0294 | Legnano | Milano | 20025 | Italy |
| Local Institution - 0265 | Milan | Milano | 20162 | Italy |
| Local Institution - 0410 | Palermo | Sicily | 90127 | Italy |
| Local Institution - 0409 | Anjo | Aichi-ken | 446-8602 | Japan |
| Local Institution - 0387 | Nagoya | Aichi-ken | 467-8602 | Japan |
| Local Institution - 0407 | Kamogawa | Chiba | 296-0041 | Japan |
| Local Institution - 0385 | Kashiwa | Chiba | 277-8577 | Japan |
| Local Institution - 0386 | Isehara | Kanagawa | 259-1193 | Japan |
| Local Institution - 0390 | Ōsaka-sayama | Osaka | 589-8511 | Japan |
| Local Institution - 0381 | Shimotsuga | Tochigi | 321-0293 | Japan |
| Local Institution - 0382 | Koto | Tokyo | 135-8550 | Japan |
| Local Institution - 0419 | Aomori | 030-8553 | Japan |
| Local Institution - 0383 | Chiba | 260-8677 | Japan |
| Local Institution - 0391 | Kumamoto | 860-8556 | Japan |
| Local Institution - 0389 | Kyoto | 602-8566 | Japan |
| Local Institution - 0388 | Okayama | 701-1192 | Japan |
| Local Institution - 0384 | Tokyo | 150-8935 | Japan |
| Local Institution - 0137 | Løenskog | Akershus | 1474 | Norway |
| Local Institution - 0115 | Bergen | Hordaland | 5021 | Norway |
| Local Institution - 0193 | Oslo | 0450 | Norway |
| Local Institution - 0242 | Lisbon | Lisbon District | 1099-023 | Portugal |
| Local Institution - 0415 | Lisbon | Lisbon District | 1649-035 | Portugal |
| Local Institution - 0255 | Lisbon | 1500-650 | Portugal |
| Local Institution - 0169 | Bucharest | Bucharest | 022328 | Romania |
| Local Institution - 0171 | Brasov | 500052 | Romania |
| Local Institution - 0414 | Bucharest | 050098 | Romania |
| Local Institution - 0240 | Seongnam | Kyǒnggi-do | 13620 | South Korea |
| Local Institution - 0221 | Busan | Pusan-Kwangyǒkshi | 49201 | South Korea |
| Local Institution - 0036 | Seoul | Seoul-teukbyeolsi [Seoul] | 03080 | South Korea |
| Local Institution - 0239 | Seoul | Seoul-teukbyeolsi [Seoul] | 05505 | South Korea |
| Local Institution - 0034 | Seoul | Seoul-teukbyeolsi [Seoul] | 06351 | South Korea |
| Local Institution - 0035 | Seoul | Seoul-teukbyeolsi [Seoul] | 06591 | South Korea |
| Local Institution - 0011 | Badalona | Barcelona [Barcelona] | 08916 | Spain |
| Local Institution - 0234 | El Palmar, Murcia | Murcia, Región de | 30120 | Spain |
| Local Institution - 0008 | Pamplona | Navarre | 31008 | Spain |
| Local Institution - 0202 | Jerez de la Frontera | 11407 | Spain |
| Local Institution - 0006 | Salamanca | 37007 | Spain |
| Local Institution - 0007 | Santiago de Compostela | 15706 | Spain |
| Local Institution - 0009 | Valencia | 46026 | Spain |
| Local Institution - 0114 | Borås | Västra Götalands Län [se-14] | 501 82 | Sweden |
| Local Institution - 0111 | Gothenburg | Västra Götalands Län [se-14] | 413 45 | Sweden |
| Local Institution - 0336 | Bern | Canton of Bern | 3010 | Switzerland |
| Local Institution - 0411 | Sankt Gallen | Canton of St. Gallen | 9007 | Switzerland |
| Local Institution - 0338 | Zurich | 8063 | Switzerland |
| Local Institution - 0325 | Stanbul | Istanbul | 34214 | Turkey (Türkiye) |
| Local Institution - 0375 | Ankara | 06200 | Turkey (Türkiye) |
| Local Institution - 0188 | Izmir | 35100 | Turkey (Türkiye) |
| Local Institution - 0187 | Kayseri | 0 | Turkey (Türkiye) |
| Local Institution - 0349 | Southampton | Hampshire | SO16 0YD | United Kingdom |
| Local Institution - 0342 | London | London, City of | NW1 2PG | United Kingdom |
| Local Institution - 0350 | Cardiff | CF14 4XW | United Kingdom |
| Local Institution - 0344 | Derby | DE22 3NE | United Kingdom |
| Local Institution - 0343 | Manchester | M20 4BX | United Kingdom |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| 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 |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C467566 | pomalidomide |
| C556306 | daratumumab |
| C546027 | elotuzumab |
| C524865 | carfilzomib |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
Not provided
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