A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Multiple Myeloma Clinical Trial

— ALUMMINATE  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06232707
• Other study ID #: CA058-1019
• Secondary ID: 2023-509472-42U1
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 29, 2024
• Est. completion date: September 21, 2030

Study information

• Verified date: March 2024
• Source: Celgene
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 466
• 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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Alnuctamab
Specified dose on specified days
• Pomalidomide
Specified dose on specified days
• Daratumumab
Specified dose on specified days
• Elotuzumab
Specified dose on specified days
• Carfilzomib
Specified dose on specified days
• Dexamethasone
Specified dose on specified days

Locations

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 - 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 - 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 - 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

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

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, 

Outcome

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

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting