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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
Date last updated
31/05/2024

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
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United States of America
State/province [1] 0 0
Alabama
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United States of America
State/province [2] 0 0
California
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United States of America
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Connecticut
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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
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United States of America
State/province [6] 0 0
Kentucky
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United States of America
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Louisiana
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United States of America
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Maryland
Country [9] 0 0
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Montana
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New Jersey
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New York
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Ohio
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Pennsylvania
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State/province [14] 0 0
Rhode Island
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South Dakota
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United States of America
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Texas
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United States of America
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Washington
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma De Buenos Aires
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Austria
State/province [20] 0 0
Niederösterreich
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Austria
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Tirol
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Austria
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Salzburg
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Austria
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Wien
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Belgium
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Antwerpen
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Belgium
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Liège
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Belgium
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Namur
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Belgium
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Vlaams-Brabant
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Minas Gerais
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Rio Grande Do Norte
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São Paulo
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Brazil
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Rio de Janeiro
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Chile
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Hebei
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China
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Henan
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China
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Hubei
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China
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Hunan
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Jiangsu
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Liaoning
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China
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Shaanxi
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China
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Shandong
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China
State/province [48] 0 0
Shanghai
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China
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Shanxi
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China
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Tianjin
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Zhejiang
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Qingdao
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Czechia
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Brno-mesto
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Czechia
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Olomoucký Kraj
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Praha 2
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Languedoc-Roussillon
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Lorraine
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Nord
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Pays-de-la-Loire
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Rhône
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Sachsen
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Hamburg
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Attikí
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Vas
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Budapest
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Andhra Pradesh
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India
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Haryana
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Karnataka
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Uttar Pradesh
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West Bengal
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Cork
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Milano
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Sicilia
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Aichi
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Chiba
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Kanagawa
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Osaka
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Tochigi
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Japan
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Tokyo
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Japan
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Aomori
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Kumamoto
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Kyoto
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Japan
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Okayama
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Pusan-Kwangyokshi
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Korea, Republic of
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Seoul-teukbyeolsi [Seoul]
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Norway
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Akershus
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Norway
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Hordaland
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Norway
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Oslo
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Portugal
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Lisboa
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Romania
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Bucure?ti
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Romania
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Brasov
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Spain
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Barcelona [Barcelona]
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Spain
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Murcia, Región De
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Navarra
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Jerez de la Frontera
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Salamanca
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Santiago de Compostela
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Spain
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València
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Sweden
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Västra Götalands Län [se-14]
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Switzerland
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Berne
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Switzerland
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Sankt Gallen
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Switzerland
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Zürich
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Turkey
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Istanbul
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Ankara
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Turkey
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Izmir
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Turkey
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Kayseri
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United Kingdom
State/province [114] 0 0
Hampshire
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United Kingdom
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London, City Of
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United Kingdom
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Cardiff
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United Kingdom
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Derby
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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
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).
Trial website
https://clinicaltrials.gov/study/NCT06232707
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06232707