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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06232707




Registration number
NCT06232707
Ethics application status
Date submitted
22/01/2024
Date registered
31/01/2024

Titles & IDs
Public title
A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
Scientific 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
Secondary ID [1] 0 0
2023-509472-42
Secondary ID [2] 0 0
CA058-1019
Universal Trial Number (UTN)
Trial acronym
ALUMMINATE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Myeloma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alnuctamab
Treatment: Drugs - Pomalidomide
Treatment: Drugs - Daratumumab
Treatment: Drugs - Elotuzumab
Treatment: Drugs - Carfilzomib
Treatment: Drugs - Dexamethasone

Experimental: Arm A: Alnuctamab -

Active comparator: Arm B: Standard of Care Regimens -


Treatment: Drugs: Alnuctamab
Specified dose on specified days

Treatment: Drugs: Pomalidomide
Specified dose on specified days

Treatment: Drugs: Daratumumab
Specified dose on specified days

Treatment: Drugs: Elotuzumab
Specified dose on specified days

Treatment: Drugs: Carfilzomib
Specified dose on specified days

Treatment: Drugs: Dexamethasone
Specified dose on specified days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Up to 5 years
Secondary outcome [2] 0 0
Overall response (OR)
Timepoint [2] 0 0
Up to 5 years
Secondary outcome [3] 0 0
Complete response (CR) or better
Timepoint [3] 0 0
Up to 5 years
Secondary outcome [4] 0 0
Very good partial response (VGPR) or better
Timepoint [4] 0 0
Up to 5 years
Secondary outcome [5] 0 0
Time to response (TTR)
Timepoint [5] 0 0
Up to 5 years
Secondary outcome [6] 0 0
Duration of response (DOR)
Timepoint [6] 0 0
Up to 5 years
Secondary outcome [7] 0 0
Time to progression (TTP)
Timepoint [7] 0 0
Up to 5 years
Secondary outcome [8] 0 0
Time to next treatment (TTNT)
Timepoint [8] 0 0
Up to 5 years
Secondary outcome [9] 0 0
Progression-free survival 2 (PFS2)
Timepoint [9] 0 0
Up to 5 years
Secondary outcome [10] 0 0
Restricted mean DOR (RMDOR)
Timepoint [10] 0 0
Up to 5 years
Secondary outcome [11] 0 0
Minimal residual disease (MRD) negativity rate
Timepoint [11] 0 0
Up to 5 years
Secondary outcome [12] 0 0
Incidence of adverse events (AEs)
Timepoint [12] 0 0
Up to 5 years
Secondary outcome [13] 0 0
Incidence of serious adverse events (SAEs)
Timepoint [13] 0 0
Up to 5 years
Secondary outcome [14] 0 0
Change from baseline in subscale scores of European organization for research and treatment of cancer - quality of life core 30 (EORTC QLQ-C30)
Timepoint [14] 0 0
Up to 5 years
Secondary outcome [15] 0 0
Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20)
Timepoint [15] 0 0
Up to 5 years

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
3/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/09/2030
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Local Institution - 0260 - Liverpool
Recruitment hospital [2] 0 0
Local Institution - 0246 - Macquarie University
Recruitment hospital [3] 0 0
Local Institution - 0022 - Waratah
Recruitment hospital [4] 0 0
Local Institution - 0397 - Brisbane
Recruitment hospital [5] 0 0
Local Institution - 0021 - Box Hill
Recruitment hospital [6] 0 0
Local Institution - 0019 - Clayton
Recruitment hospital [7] 0 0
Local Institution - 0018 - Melbourne
Recruitment hospital [8] 0 0
Local Institution - 0003 - Melbourne
Recruitment postcode(s) [1] 0 0
2170 - Liverpool
Recruitment postcode(s) [2] 0 0
2109 - Macquarie University
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
4120 - Brisbane
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3004 - Melbourne
Recruitment postcode(s) [8] 0 0
3065 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Montana
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
South Dakota
Country [16] 0 0
United States of America
State/province [16] 0 0
Texas
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Ciudad Autónoma De Buenos Aires
Country [20] 0 0
Austria
State/province [20] 0 0
Niederösterreich
Country [21] 0 0
Austria
State/province [21] 0 0
Tirol
Country [22] 0 0
Austria
State/province [22] 0 0
Salzburg
Country [23] 0 0
Austria
State/province [23] 0 0
Wien
Country [24] 0 0
Belgium
State/province [24] 0 0
Antwerpen
Country [25] 0 0
Belgium
State/province [25] 0 0
Liège
Country [26] 0 0
Belgium
State/province [26] 0 0
Namur
Country [27] 0 0
Belgium
State/province [27] 0 0
Vlaams-Brabant
Country [28] 0 0
Brazil
State/province [28] 0 0
Minas Gerais
Country [29] 0 0
Brazil
State/province [29] 0 0
Rio Grande Do Norte
Country [30] 0 0
Brazil
State/province [30] 0 0
São Paulo
Country [31] 0 0
Brazil
State/province [31] 0 0
Rio de Janeiro
Country [32] 0 0
Canada
State/province [32] 0 0
Alberta
Country [33] 0 0
Canada
State/province [33] 0 0
Ontario
Country [34] 0 0
Canada
State/province [34] 0 0
Quebec
Country [35] 0 0
Chile
State/province [35] 0 0
Metropolitana DE Santiago
Country [36] 0 0
Chile
State/province [36] 0 0
Región Metropolitana De Santiago
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China
State/province [37] 0 0
Beijing
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China
State/province [38] 0 0
Chongqing
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China
State/province [39] 0 0
Guangdong
Country [40] 0 0
China
State/province [40] 0 0
Hebei
Country [41] 0 0
China
State/province [41] 0 0
Henan
Country [42] 0 0
China
State/province [42] 0 0
Hubei
Country [43] 0 0
China
State/province [43] 0 0
Hunan
Country [44] 0 0
China
State/province [44] 0 0
Jiangsu
Country [45] 0 0
China
State/province [45] 0 0
Liaoning
Country [46] 0 0
China
State/province [46] 0 0
Shaanxi
Country [47] 0 0
China
State/province [47] 0 0
Shandong
Country [48] 0 0
China
State/province [48] 0 0
Shanghai
Country [49] 0 0
China
State/province [49] 0 0
Shanxi
Country [50] 0 0
China
State/province [50] 0 0
Tianjin
Country [51] 0 0
China
State/province [51] 0 0
Zhejiang
Country [52] 0 0
China
State/province [52] 0 0
Qingdao
Country [53] 0 0
Czechia
State/province [53] 0 0
Brno-mesto
Country [54] 0 0
Czechia
State/province [54] 0 0
Olomoucký Kraj
Country [55] 0 0
Czechia
State/province [55] 0 0
Praha 2
Country [56] 0 0
France
State/province [56] 0 0
Haute-Garonne
Country [57] 0 0
France
State/province [57] 0 0
Languedoc-Roussillon
Country [58] 0 0
France
State/province [58] 0 0
Lorraine
Country [59] 0 0
France
State/province [59] 0 0
Nord
Country [60] 0 0
France
State/province [60] 0 0
Pays-de-la-Loire
Country [61] 0 0
France
State/province [61] 0 0
Rhône
Country [62] 0 0
Germany
State/province [62] 0 0
Baden-Württemberg
Country [63] 0 0
Germany
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Sachsen
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Germany
State/province [64] 0 0
Hamburg
Country [65] 0 0
Greece
State/province [65] 0 0
Attikí
Country [66] 0 0
Hungary
State/province [66] 0 0
Szabolcs-Szatmár-Bereg
Country [67] 0 0
Hungary
State/province [67] 0 0
Vas
Country [68] 0 0
Hungary
State/province [68] 0 0
Budapest
Country [69] 0 0
India
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Andhra Pradesh
Country [70] 0 0
India
State/province [70] 0 0
Haryana
Country [71] 0 0
India
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Karnataka
Country [72] 0 0
India
State/province [72] 0 0
Uttar Pradesh
Country [73] 0 0
India
State/province [73] 0 0
West Bengal
Country [74] 0 0
Ireland
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Cork
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Ireland
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Dublin
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Ireland
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Limerick
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Italy
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Emilia-Romagna
Country [78] 0 0
Italy
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Milano
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Italy
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Sicilia
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Kanagawa
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Japan
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Osaka
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Japan
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Tochigi
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Japan
State/province [85] 0 0
Tokyo
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Japan
State/province [86] 0 0
Aomori
Country [87] 0 0
Japan
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Kumamoto
Country [88] 0 0
Japan
State/province [88] 0 0
Kyoto
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Japan
State/province [89] 0 0
Okayama
Country [90] 0 0
Korea, Republic of
State/province [90] 0 0
Kyonggi-do
Country [91] 0 0
Korea, Republic of
State/province [91] 0 0
Pusan-Kwangyokshi
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Seoul-teukbyeolsi [Seoul]
Country [93] 0 0
Norway
State/province [93] 0 0
Akershus
Country [94] 0 0
Norway
State/province [94] 0 0
Hordaland
Country [95] 0 0
Norway
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Oslo
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Portugal
State/province [96] 0 0
Lisboa
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Romania
State/province [97] 0 0
Bucure?ti
Country [98] 0 0
Romania
State/province [98] 0 0
Brasov
Country [99] 0 0
Spain
State/province [99] 0 0
Barcelona [Barcelona]
Country [100] 0 0
Spain
State/province [100] 0 0
Murcia, Región De
Country [101] 0 0
Spain
State/province [101] 0 0
Navarra
Country [102] 0 0
Spain
State/province [102] 0 0
Jerez de la Frontera
Country [103] 0 0
Spain
State/province [103] 0 0
Salamanca
Country [104] 0 0
Spain
State/province [104] 0 0
Santiago de Compostela
Country [105] 0 0
Spain
State/province [105] 0 0
València
Country [106] 0 0
Sweden
State/province [106] 0 0
Västra Götalands Län [se-14]
Country [107] 0 0
Switzerland
State/province [107] 0 0
Berne
Country [108] 0 0
Switzerland
State/province [108] 0 0
Sankt Gallen
Country [109] 0 0
Switzerland
State/province [109] 0 0
Zürich
Country [110] 0 0
Turkey
State/province [110] 0 0
Istanbul
Country [111] 0 0
Turkey
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Ankara
Country [112] 0 0
Turkey
State/province [112] 0 0
Izmir
Country [113] 0 0
Turkey
State/province [113] 0 0
Kayseri
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Hampshire
Country [115] 0 0
United Kingdom
State/province [115] 0 0
London, City Of
Country [116] 0 0
United Kingdom
State/province [116] 0 0
Cardiff
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Derby
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Celgene
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
See Plan Description
Available to whom?
See Plan Description
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06232707