Clinical trial NCT06232707: A Study to Evaluate Efficacy and Safety of Alnuctamab Compared to Standard of Care Regimens in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)
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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Relapsed or Refractory Multiple Myeloma
BMS-986349
CC-93269
RRMM
Alnuctamab
CA058-1019
ALUMMINATE RRMM
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2024-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

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.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 5 years
measure: Overall response (OR)
timeFrame: Up to 5 years
measure: Complete response (CR) or better
timeFrame: Up to 5 years
measure: Very good partial response (VGPR) or better
timeFrame: Up to 5 years
measure: Time to response (TTR)
timeFrame: Up to 5 years
measure: Duration of response (DOR)
timeFrame: Up to 5 years
measure: Time to progression (TTP)
timeFrame: Up to 5 years
measure: Time to next treatment (TTNT)
timeFrame: Up to 5 years
measure: Progression-free survival 2 (PFS2)
timeFrame: Up to 5 years
measure: Restricted mean DOR (RMDOR)
timeFrame: Up to 5 years
measure: Minimal residual disease (MRD) negativity rate
timeFrame: Up to 5 years
measure: Incidence of adverse events (AEs)
timeFrame: Up to 5 years
measure: Incidence of serious adverse events (SAEs)
timeFrame: Up to 5 years
measure: Change from baseline in subscale scores of European organization for research and treatment of cancer - quality of life core 30 (EORTC QLQ-C30)
timeFrame: Up to 5 years
measure: Change from baseline in subscale scores of European quality of life multiple myeloma module (EORTC QLQ-MY20)
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Local Institution - 0151
state: Alabama
city: Los Angeles
country: United States
facility: Local Institution - 0088
state: California
city: Stanford
country: United States
facility: Local Institution - 0358
state: California
city: New Haven
country: United States
facility: Local Institution - 0355
state: Connecticut
city: Washington
country: United States
facility: Local Institution - 0434
state: District of Columbia
city: Wichita
country: United States
facility: Local Institution - 0433
state: Kansas
city: Saint Matthews
country: United States
facility: Local Institution - 0439
state: Kentucky
city: New Orleans
country: United States
facility: Local Institution - 0323
state: Louisiana
city: Baltimore
country: United States
facility: Local Institution - 0324
state: Maryland
city: Bethesda
country: United States
facility: Local Institution - 0441
state: Maryland
city: Billings
country: United States
facility: Local Institution - 0435
state: Montana
city: Hackensack
country: United States
facility: Local Institution - 0157
state: New Jersey
city: Summit
country: United States
facility: Local Institution - 0359
state: New Jersey
city: Lake Success
country: United States
facility: Local Institution - 0430
state: New York
city: New York
country: United States
facility: Local Institution - 0396
state: New York
city: Cincinnati
country: United States
facility: Local Institution - 0306
state: Ohio
city: Cleveland
country: United States
facility: Local Institution - 0199
state: Ohio
city: Pittsburgh
country: United States
facility: Local Institution - 0437
state: Pennsylvania
city: Providence
country: United States
facility: Local Institution - 0352
state: Rhode Island
city: Watertown
country: United States
facility: Local Institution - 0420
state: South Dakota
city: Dallas
country: United States
facility: Local Institution - 0168
state: Texas
city: Seattle
country: United States
facility: Local Institution - 0405
state: Washington
city: Florencio Varela
country: Argentina
facility: Local Institution - 0222
state: Buenos Aires
city: La Plata
country: Argentina
facility: Local Institution - 0001
state: Buenos Aires
city: Pilar
country: Argentina
facility: Local Institution - 0262
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Local Institution - 0002
state: Ciudad Autónoma De Buenos Aires
city: Liverpool
country: Australia
facility: Local Institution - 0260
state: New South Wales
city: Macquarie University
country: Australia
facility: Local Institution - 0246
state: New South Wales
city: Waratah
country: Australia
facility: Local Institution - 0022
state: New South Wales
city: Brisbane
country: Australia
facility: Local Institution - 0397
state: Queensland
city: Box Hill
country: Australia
facility: Local Institution - 0021
state: Victoria
city: Clayton
country: Australia
facility: Local Institution - 0019
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0018
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution - 0003
state: Victoria
city: St. Polten
country: Austria
facility: Local Institution - 0333
state: Niederösterreich
city: Innsbruck
country: Austria
facility: Local Institution - 0337
state: Tirol
city: Salzburg
country: Austria
facility: Local Institution - 0334
city: Wien
country: Austria
facility: Local Institution - 0332
city: Brasschaat
country: Belgium
facility: Local Institution - 0284
state: Antwerpen
city: Verviers
country: Belgium
facility: Local Institution - 0280
state: Liège
city: Yvoir
country: Belgium
facility: Local Institution - 0279
state: Namur
city: Leuven
country: Belgium
facility: Local Institution - 0286
state: Vlaams-Brabant
city: Belo Horizonte
country: Brazil
facility: Local Institution - 0274
state: Minas Gerais
city: Natal
country: Brazil
facility: Local Institution - 0351
state: Rio Grande Do Norte
city: Sao Paulo
country: Brazil
facility: Local Institution - 0369
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Local Institution - 0291
city: São Paulo
country: Brazil
facility: Local Institution - 0211
city: Calgary
country: Canada
facility: Local Institution - 0417
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution - 0423
state: Alberta
city: London
country: Canada
facility: Local Institution - 0402
state: Ontario
city: Toronto
country: Canada
facility: Local Institution - 0395
state: Ontario
city: Montreal
country: Canada
facility: Local Institution - 0031
state: Quebec
city: Montréal
country: Canada
facility: Local Institution - 0098
state: Quebec
city: Santiago
country: Chile
facility: Local Institution - 0027
state: Metropolitana DE Santiago
city: Santiago
country: Chile
facility: Local Institution - 0030
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0026
state: Región Metropolitana De Santiago
city: Santiago
country: Chile
facility: Local Institution - 0029
state: Región Metropolitana De Santiago
city: Beijing
country: China
facility: Local Institution - 0413
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0230
state: Beijing
city: Beijing
country: China
facility: Local Institution - 0040
state: Beijing
city: Changping
country: China
facility: Local Institution - 0366
state: Beijing
city: Chongqing
country: China
facility: Local Institution - 0057
state: Chongqing
city: Guangzhou
country: China
facility: Local Institution - 0066
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0080
state: Guangdong
city: Guangzhou
country: China
facility: Local Institution - 0226
state: Guangdong
city: Shenzhen
country: China
facility: Local Institution - 0368
state: Guangdong
city: Baoding
country: China
facility: Local Institution - 0365
state: Hebei
city: Shijiazhuang
country: China
facility: Local Institution - 0082
state: Hebei
city: Zhengzhou
country: China
facility: Local Institution - 0041
state: Henan
city: Wuhan
country: China
facility: Local Institution - 0075
state: Hubei
city: Changsha
country: China
facility: Local Institution - 0062
state: Hunan
city: Changsha
country: China
facility: Local Institution - 0053
state: Hunan
city: Nanjing
country: China
facility: Local Institution - 0055
state: Jiangsu
city: Suzhou
country: China
facility: Local Institution - 0067
state: Jiangsu
city: Xuzhou
country: China
facility: Local Institution - 0377
state: Jiangsu
city: Shenyang
country: China
facility: Local Institution - 0044
state: Liaoning
city: Xi'An
country: China
facility: Local Institution - 0072
state: Shaanxi
city: Jinan
country: China
facility: Local Institution - 0077
state: Shandong
city: Jinan
country: China
facility: Local Institution - 0083
state: Shandong
city: Shanghai
country: China
facility: Local Institution - 0273
state: Shanghai
city: Shanghai
country: China
facility: Local Institution - 0421
state: Shanghai
city: Taiyuan
country: China
facility: Local Institution - 0245
state: Shanxi
city: Tianjin
country: China
facility: Local Institution - 0056
state: Tianjin
city: Tianjin
country: China
facility: Local Institution - 0422
state: Tianjin
city: Hangzhou
country: China
facility: Local Institution - 0070
state: Zhejiang
city: Hangzhou
country: China
facility: Local Institution - 0203
state: Zhejiang
city: Qingdao
country: China
facility: Local Institution - 0367
city: Brno
country: Czechia
facility: Local Institution - 0013
state: Brno-město
city: Olomouc
country: Czechia
facility: Local Institution - 0247
state: Olomoucký Kraj
city: Praha 2
country: Czechia
facility: Local Institution - 0012
city: Toulouse
country: France
facility: Local Institution - 0118
state: Haute-Garonne
city: Montpellier
country: France
facility: Local Institution - 0225
state: Languedoc-Roussillon
city: Vandoeuvre lès Nancy
country: France
facility: Local Institution - 0224
state: Lorraine
city: Lille
country: France
facility: Local Institution - 0084
state: Nord
city: Nantes
country: France
facility: Local Institution - 0085
state: Pays-de-la-Loire
city: Pierre-Bénite
country: France
facility: Local Institution - 0192
state: Rhône
city: Heidelberg
country: Germany
facility: Local Institution - 0331
state: Baden-Württemberg
city: Tübingen
country: Germany
facility: Local Institution - 0330
state: Baden-Württemberg
city: Dresden
country: Germany
facility: Local Institution - 0335
state: Sachsen
city: Leipzig
country: Germany
facility: Local Institution - 0329
state: Sachsen
city: Hamburg
country: Germany
facility: Local Institution - 0339
city: Athens
country: Greece
facility: Local Institution - 0004
state: Attikí
city: Chaidari
country: Greece
facility: Local Institution - 0136
state: Attikí
city: Nyiregyhaza
country: Hungary
facility: Local Institution - 0103
state: Szabolcs-Szatmár-Bereg
city: Szombathely
country: Hungary
facility: Local Institution - 0108
state: Vas
city: Budapest
country: Hungary
facility: Local Institution - 0104
city: Budapest
country: Hungary
facility: Local Institution - 0105
city: Visakhapatnam
country: India
facility: Local Institution - 0370
state: Andhra Pradesh
city: Gurugram
country: India
facility: Local Institution - 0362
state: Haryana
city: Bangalore
country: India
facility: Local Institution - 0403
state: Karnataka
city: Lucknow
country: India
facility: Local Institution - 0399
state: Uttar Pradesh
city: Kolkata
country: India
facility: Local Institution - 0398
state: West Bengal
city: Cork
country: Ireland
facility: Local Institution - 0281
city: Dublin
country: Ireland
facility: Local Institution - 0371
city: Dublin
country: Ireland
facility: Local Institution - 0285
city: Limerick
country: Ireland
facility: Local Institution - 0269
city: Meldola
country: Italy
facility: Local Institution - 0096
state: Emilia-Romagna
city: Legnano
country: Italy
facility: Local Institution - 0294
state: Milano
city: Milan
country: Italy
facility: Local Institution - 0265
state: Milano
city: Palermo
country: Italy
facility: Local Institution - 0410
state: Sicilia
city: Anjo
country: Japan
facility: Local Institution - 0409
state: Aichi
city: Nagoya
country: Japan
facility: Local Institution - 0387
state: Aichi
city: Kamogawa
country: Japan
facility: Local Institution - 0407
state: Chiba
city: Kashiwa
country: Japan
facility: Local Institution - 0385
state: Chiba
city: Isehara
country: Japan
facility: Local Institution - 0386
state: Kanagawa
city: Osaka-sayama
country: Japan
facility: Local Institution - 0390
state: Osaka
city: Shimotsuga
country: Japan
facility: Local Institution - 0381
state: Tochigi
city: Koto
country: Japan
facility: Local Institution - 0382
state: Tokyo
city: Aomori
country: Japan
facility: Local Institution - 0419
city: Chiba
country: Japan
facility: Local Institution - 0383
city: Kumamoto
country: Japan
facility: Local Institution - 0391
city: Kyoto
country: Japan
facility: Local Institution - 0389
city: Okayama
country: Japan
facility: Local Institution - 0388
city: Tokyo
country: Japan
facility: Local Institution - 0384
city: Seongnam
country: Korea, Republic of
facility: Local Institution - 0240
state: Kyǒnggi-do
city: Busan
country: Korea, Republic of
facility: Local Institution - 0221
state: Pusan-Kwangyǒkshi
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0036
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0239
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0034
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Local Institution - 0035
state: Seoul-teukbyeolsi [Seoul]
city: Løenskog
country: Norway
facility: Local Institution - 0137
state: Akershus
city: Bergen
country: Norway
facility: Local Institution - 0115
state: Hordaland
city: Oslo
country: Norway
facility: Local Institution - 0193
city: Lisbon
country: Portugal
facility: Local Institution - 0242
state: Lisboa
city: Lisbon
country: Portugal
facility: Local Institution - 0415
state: Lisboa
city: Lisboa
country: Portugal
facility: Local Institution - 0255
city: Bucuresti
country: Romania
facility: Local Institution - 0169
state: București
city: Brasov
country: Romania
facility: Local Institution - 0171
city: București
country: Romania
facility: Local Institution - 0414
city: Badalona
country: Spain
facility: Local Institution - 0011
state: Barcelona [Barcelona]
city: El Palmar, Murcia
country: Spain
facility: Local Institution - 0234
state: Murcia, Región De
city: Pamplona
country: Spain
facility: Local Institution - 0008
state: Navarra
city: Jerez de la Frontera
country: Spain
facility: Local Institution - 0202
city: Salamanca
country: Spain
facility: Local Institution - 0006
city: Santiago de Compostela
country: Spain
facility: Local Institution - 0007
city: València
country: Spain
facility: Local Institution - 0009
city: Borås
country: Sweden
facility: Local Institution - 0114
state: Västra Götalands Län [se-14]
city: Gothenburg
country: Sweden
facility: Local Institution - 0111
state: Västra Götalands Län [se-14]
city: Bern
country: Switzerland
facility: Local Institution - 0336
state: Berne
city: st.Gallen
country: Switzerland
facility: Local Institution - 0411
state: Sankt Gallen
city: Zürich
country: Switzerland
facility: Local Institution - 0338
city: Stanbul
country: Turkey
facility: Local Institution - 0325
state: İstanbul
city: Ankara
country: Turkey
facility: Local Institution - 0375
city: İzmir
country: Turkey
facility: Local Institution - 0188
city: Kayseri
country: Turkey
facility: Local Institution - 0187
city: Southampton
country: United Kingdom
facility: Local Institution - 0349
state: Hampshire
city: London
country: United Kingdom
facility: Local Institution - 0342
state: London, City Of
city: Cardiff
country: United Kingdom
facility: Local Institution - 0350
city: Derby
country: United Kingdom
facility: Local Institution - 0344
city: Manchester
country: United Kingdom
facility: Local Institution - 0343
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: