Multiple Myeloma Clinical Trial
— ALUMMINATEOfficial title:
A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM) - ALUMMINATE RRMM
| Verified date | May 2024 |
| Source | Celgene |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | September 21, 2030 |
| Est. primary completion date | November 16, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. - Must have measurable disease (as determined by central laboratory). - Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, or 2 at the time of the screening. Exclusion Criteria - Active, uncontrolled, or suspected infection. - Known current, or history of, central nervous system involvement of multiple myeloma. - History or presence of clinically relevant CNS pathology. - Received prior BCMA-targeted TCE or BCMA-targeted CAR-T therapy. - Previously received allogeneic stem cell transplantation at any time or received autologous stem cell transplantation within 3 months of initiating study intervention. - Other protocol-defined Inclusion/Exclusion criteria apply. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Local Institution - 0002 | Buenos Aires | Ciudad Autónoma De Buenos Aires |
| Argentina | Local Institution - 0222 | Florencio Varela | Buenos Aires |
| Argentina | Local Institution - 0001 | La Plata | Buenos Aires |
| Argentina | Local Institution - 0262 | Pilar | Buenos Aires |
| Australia | Local Institution - 0021 | Box Hill | Victoria |
| Australia | Local Institution - 0397 | Brisbane | Queensland |
| Australia | Local Institution - 0019 | Clayton | Victoria |
| Australia | Local Institution - 0260 | Liverpool | New South Wales |
| Australia | Local Institution - 0246 | Macquarie University | New South Wales |
| Australia | Local Institution - 0003 | Melbourne | Victoria |
| Australia | Local Institution - 0018 | Melbourne | Victoria |
| Australia | Local Institution - 0022 | Waratah | New South Wales |
| Austria | Local Institution - 0337 | Innsbruck | Tirol |
| Austria | Local Institution - 0334 | Salzburg | |
| Austria | Local Institution - 0333 | St. Polten | Niederösterreich |
| Austria | Local Institution - 0332 | Wien | |
| Belgium | Local Institution - 0284 | Brasschaat | Antwerpen |
| Belgium | Local Institution - 0286 | Leuven | Vlaams-Brabant |
| Belgium | Local Institution - 0280 | Verviers | Liège |
| Belgium | Local Institution - 0279 | Yvoir | Namur |
| Brazil | Local Institution - 0274 | Belo Horizonte | Minas Gerais |
| Brazil | Local Institution - 0351 | Natal | Rio Grande Do Norte |
| Brazil | Local Institution - 0291 | Rio de Janeiro | |
| Brazil | Local Institution - 0369 | Sao Paulo | São Paulo |
| Brazil | Local Institution - 0211 | São Paulo | |
| Canada | Local Institution - 0417 | Calgary | Alberta |
| Canada | Local Institution - 0423 | Edmonton | Alberta |
| Canada | Local Institution - 0402 | London | Ontario |
| Canada | Local Institution - 0031 | Montreal | Quebec |
| Canada | Local Institution - 0098 | Montréal | Quebec |
| Canada | Local Institution - 0395 | Toronto | Ontario |
| Chile | Local Institution - 0026 | Santiago | Región Metropolitana De Santiago |
| Chile | Local Institution - 0027 | Santiago | Metropolitana DE Santiago |
| Chile | Local Institution - 0029 | Santiago | Región Metropolitana De Santiago |
| Chile | Local Institution - 0030 | Santiago | Región Metropolitana De Santiago |
| China | Local Institution - 0365 | Baoding | Hebei |
| China | Local Institution - 0040 | Beijing | Beijing |
| China | Local Institution - 0230 | Beijing | Beijing |
| China | Local Institution - 0413 | Beijing | Beijing |
| China | Local Institution - 0366 | Changping | Beijing |
| China | Local Institution - 0053 | Changsha | Hunan |
| China | Local Institution - 0062 | Changsha | Hunan |
| China | Local Institution - 0057 | Chongqing | Chongqing |
| China | Local Institution - 0066 | Guangzhou | Guangdong |
| China | Local Institution - 0080 | Guangzhou | Guangdong |
| China | Local Institution - 0226 | Guangzhou | Guangdong |
| China | Local Institution - 0070 | Hangzhou | Zhejiang |
| China | Local Institution - 0203 | Hangzhou | Zhejiang |
| China | Local Institution - 0077 | Jinan | Shandong |
| China | Local Institution - 0083 | Jinan | Shandong |
| China | Local Institution - 0055 | Nanjing | Jiangsu |
| China | Local Institution - 0367 | Qingdao | |
| China | Local Institution - 0273 | Shanghai | Shanghai |
| China | Local Institution - 0421 | Shanghai | Shanghai |
| China | Local Institution - 0044 | Shenyang | Liaoning |
| China | Local Institution - 0368 | Shenzhen | Guangdong |
| China | Local Institution - 0082 | Shijiazhuang | Hebei |
| China | Local Institution - 0067 | Suzhou | Jiangsu |
| China | Local Institution - 0245 | Taiyuan | Shanxi |
| China | Local Institution - 0056 | Tianjin | Tianjin |
| China | Local Institution - 0422 | Tianjin | Tianjin |
| China | Local Institution - 0075 | Wuhan | Hubei |
| China | Local Institution - 0072 | Xi'An | Shaanxi |
| China | Local Institution - 0377 | Xuzhou | Jiangsu |
| China | Local Institution - 0041 | Zhengzhou | Henan |
| Czechia | Local Institution - 0013 | Brno | Brno-mesto |
| Czechia | Local Institution - 0247 | Olomouc | Olomoucký Kraj |
| Czechia | Local Institution - 0012 | Praha 2 | |
| France | Local Institution - 0084 | Lille | Nord |
| France | Local Institution - 0225 | Montpellier | Languedoc-Roussillon |
| France | Local Institution - 0085 | Nantes | Pays-de-la-Loire |
| France | Local Institution - 0192 | Pierre-Bénite | Rhône |
| France | Local Institution - 0118 | Toulouse | Haute-Garonne |
| France | Local Institution - 0224 | Vandoeuvre lès Nancy | Lorraine |
| Germany | Local Institution - 0335 | Dresden | Sachsen |
| Germany | Local Institution - 0339 | Hamburg | |
| Germany | Local Institution - 0331 | Heidelberg | Baden-Württemberg |
| Germany | Local Institution - 0329 | Leipzig | Sachsen |
| Germany | Local Institution - 0330 | Tübingen | Baden-Württemberg |
| Greece | Local Institution - 0004 | Athens | Attikí |
| Greece | Local Institution - 0136 | Chaidari | Attikí |
| Hungary | Local Institution - 0104 | Budapest | |
| Hungary | Local Institution - 0105 | Budapest | |
| Hungary | Local Institution - 0103 | Nyiregyhaza | Szabolcs-Szatmár-Bereg |
| Hungary | Local Institution - 0108 | Szombathely | Vas |
| India | Local Institution - 0403 | Bangalore | Karnataka |
| India | Local Institution - 0362 | Gurugram | Haryana |
| India | Local Institution - 0398 | Kolkata | West Bengal |
| India | Local Institution - 0399 | Lucknow | Uttar Pradesh |
| India | Local Institution - 0370 | Visakhapatnam | Andhra Pradesh |
| Ireland | Local Institution - 0281 | Cork | |
| Ireland | Local Institution - 0285 | Dublin | |
| Ireland | Local Institution - 0371 | Dublin | |
| Ireland | Local Institution - 0269 | Limerick | |
| Italy | Local Institution - 0294 | Legnano | Milano |
| Italy | Local Institution - 0096 | Meldola | Emilia-Romagna |
| Italy | Local Institution - 0265 | Milan | Milano |
| Italy | Local Institution - 0410 | Palermo | Sicilia |
| Japan | Local Institution - 0409 | Anjo | Aichi |
| Japan | Local Institution - 0419 | Aomori | |
| Japan | Local Institution - 0383 | Chiba | |
| Japan | Local Institution - 0386 | Isehara | Kanagawa |
| Japan | Local Institution - 0407 | Kamogawa | Chiba |
| Japan | Local Institution - 0385 | Kashiwa | Chiba |
| Japan | Local Institution - 0382 | Koto | Tokyo |
| Japan | Local Institution - 0391 | Kumamoto | |
| Japan | Local Institution - 0389 | Kyoto | |
| Japan | Local Institution - 0387 | Nagoya | Aichi |
| Japan | Local Institution - 0388 | Okayama | |
| Japan | Local Institution - 0390 | Osaka-sayama | Osaka |
| Japan | Local Institution - 0381 | Shimotsuga | Tochigi |
| Japan | Local Institution - 0384 | Tokyo | |
| Korea, Republic of | Local Institution - 0221 | Busan | Pusan-Kwangyokshi |
| Korea, Republic of | Local Institution - 0240 | Seongnam | Kyonggi-do |
| Korea, Republic of | Local Institution - 0034 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Local Institution - 0035 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Local Institution - 0036 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Korea, Republic of | Local Institution - 0239 | Seoul | Seoul-teukbyeolsi [Seoul] |
| Norway | Local Institution - 0115 | Bergen | Hordaland |
| Norway | Local Institution - 0137 | Løenskog | Akershus |
| Norway | Local Institution - 0193 | Oslo | |
| Portugal | Local Institution - 0255 | Lisboa | |
| Portugal | Local Institution - 0242 | Lisbon | Lisboa |
| Portugal | Local Institution - 0415 | Lisbon | Lisboa |
| Romania | Local Institution - 0171 | Brasov | |
| Romania | Local Institution - 0414 | Bucure?ti | |
| Romania | Local Institution - 0169 | Bucuresti | Bucure?ti |
| Spain | Local Institution - 0011 | Badalona | Barcelona [Barcelona] |
| Spain | Local Institution - 0234 | El Palmar, Murcia | Murcia, Región De |
| Spain | Local Institution - 0202 | Jerez de la Frontera | |
| Spain | Local Institution - 0008 | Pamplona | Navarra |
| Spain | Local Institution - 0006 | Salamanca | |
| Spain | Local Institution - 0007 | Santiago de Compostela | |
| Spain | Local Institution - 0009 | València | |
| Sweden | Local Institution - 0114 | Borås | Västra Götalands Län [se-14] |
| Sweden | Local Institution - 0111 | Gothenburg | Västra Götalands Län [se-14] |
| Switzerland | Local Institution - 0336 | Bern | Berne |
| Switzerland | Local Institution - 0411 | st.Gallen | Sankt Gallen |
| Switzerland | Local Institution - 0338 | Zürich | |
| Turkey | Local Institution - 0375 | Ankara | |
| Turkey | Local Institution - 0188 | Izmir | |
| Turkey | Local Institution - 0187 | Kayseri | |
| Turkey | Local Institution - 0325 | Stanbul | Istanbul |
| United Kingdom | Local Institution - 0350 | Cardiff | |
| United Kingdom | Local Institution - 0344 | Derby | |
| United Kingdom | Local Institution - 0342 | London | London, City Of |
| United Kingdom | Local Institution - 0343 | Manchester | |
| United Kingdom | Local Institution - 0349 | Southampton | Hampshire |
| United States | Local Institution - 0324 | Baltimore | Maryland |
| United States | Local Institution - 0441 | Bethesda | Maryland |
| United States | Local Institution - 0435 | Billings | Montana |
| United States | Local Institution - 0151 | Birmingham | Alabama |
| United States | Local Institution - 0306 | Cincinnati | Ohio |
| United States | Local Institution - 0199 | Cleveland | Ohio |
| United States | Local Institution - 0168 | Dallas | Texas |
| United States | Local Institution - 0157 | Hackensack | New Jersey |
| United States | Local Institution - 0430 | Lake Success | New York |
| United States | Local Institution - 0088 | Los Angeles | California |
| United States | Local Institution - 0355 | New Haven | Connecticut |
| United States | Local Institution - 0323 | New Orleans | Louisiana |
| United States | Local Institution - 0396 | New York | New York |
| United States | Local Institution - 0437 | Pittsburgh | Pennsylvania |
| United States | Local Institution - 0352 | Providence | Rhode Island |
| United States | Local Institution - 0439 | Saint Matthews | Kentucky |
| United States | Local Institution - 0405 | Seattle | Washington |
| United States | Local Institution - 0358 | Stanford | California |
| United States | Local Institution - 0359 | Summit | New Jersey |
| United States | Local Institution - 0434 | Washington | District of Columbia |
| United States | Local Institution - 0420 | Watertown | South Dakota |
| United States | Local Institution - 0433 | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Celgene |
United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, France, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Korea, Republic of, Norway, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-free Survival (PFS) | Up to 5 years | ||
| Secondary | Overall Survival (OS) | Up to 5 years | ||
| Secondary | Overall response (OR) | Up to 5 years | ||
| Secondary | Complete response (CR) or better | Up to 5 years | ||
| Secondary | Very good partial response (VGPR) or better | Up to 5 years | ||
| Secondary | Time to response (TTR) | Up to 5 years | ||
| Secondary | Duration of response (DOR) | Up to 5 years | ||
| Secondary | Time to progression (TTP) | Up to 5 years | ||
| Secondary | Time to next treatment (TTNT) | Up to 5 years | ||
| Secondary | Progression-free survival 2 (PFS2) | Up to 5 years | ||
| Secondary | Restricted mean DOR (RMDOR) | Up to 5 years | ||
| Secondary | Minimal residual disease (MRD) negativity rate | Up to 5 years | ||
| Secondary | Incidence of adverse events (AEs) | Up to 5 years | ||
| Secondary | Incidence of serious adverse events (SAEs) | Up to 5 years | ||
| Secondary | 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 | ||
| Secondary | Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20) | Up to 5 years |
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