Clinical trial NCT06158841: Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma
Official title: A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Multiple Myeloma
Keywords: Cervino
Multiple Myeloma
Etentamig
Carfilzomib
Pomalidomide
Elotuzumab
Selinexor
Bortezomib
Dexamethasone
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-12-06
Enrollment: 380
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: Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM.

Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world.

In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.


Eligibility criteria: Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance of \<= 2.
* Diagnosis of relapsed/refractory (R/R) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.
* Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:

  * Serum M-protein \>= 0.5 g/dL (\>= 5 g/L).
  * Urine M-protein \>= 200 mg/24 hours.
  * In participants without measurable serum or urine M protein, serum free light chain (FLC) \>= 100 mg/L (10 mg/dL) (involved light chain)and an abnormal serum kappa lambda ratio.
* Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).
* Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.

Exclusion Criteria:

* Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.
* Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.
* Central nervous system involvement of MM.
* Has received B-cell maturation antigen (BCMA)-targeted therapy.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: Up to Approximately 5 Years
measure: Objective Response Rate (ORR)
timeFrame: Up to Approximately 5 Years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to Approximately 5 Years
measure: Change in Rate of Very Good Partial Response (VGPR) or Better (>= VGPR)
timeFrame: Up to Approximately 5 Years
measure: Change in Rate of CR or Better (>=CR)
timeFrame: Up to Approximately 5 Years
measure: Change in Rate of Minimum Residual Disease (MRD) negativity with >= CR
timeFrame: Up to Approximately 5 Years
measure: Change from Baseline in Disease Symptoms as Measured by the Disease Symptoms Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC QLQ-MY20)
timeFrame: Up to 6 Months
measure: Change from Baseline in Physical Functioning as Measured by the Physical Functioning Domain of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30)
timeFrame: Up to 6 Months
measure: Time to Response (TTR)
timeFrame: Up to Approximately 5 Years
measure: Duration of Response (DOR)
timeFrame: Up to Approximately 5 Years
measure: Time-to-Progression (TTP)
timeFrame: Up to Approximately 5 Years
measure: Time to Next Anti-lymphoma Therapy (TTNT)
timeFrame: Up to Approximately 5 Years
measure: Number of Participants with Event-free Survival (EFS)
timeFrame: Up to Approximately 5 Years
measure: Change from Baseline in Patient-Reported Outcomes Measurement Information System Fatigue Short Form 7a (PROMIS Fatigue SF 7a)
timeFrame: Up to Approximately 6 Months
measure: Change from Baseline in Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE)
timeFrame: Up to Approximately 6 Months
measure: Change from Baseline in Remaining Items in the EORTC QLQ-C30
timeFrame: Up to Approximately 6 Months
measure: Change from Baseline in Remaining Items in the EORTC QLQ-MY20
timeFrame: Up to Approximately 6 Months
measure: Change from Baseline in European Quality-of-Life 5-dimensional-5-level (EQ-5D-5L)
timeFrame: Up to Approximately 6 Months
measure: Change from Baseline in Patient Global Impression of Severity (PGIS)
timeFrame: Up to Approximately 6 Months
measure: Change from Baseline in Patient Global Impression of Change (PGIC)
timeFrame: Up to Approximately 6 Months
measure: Number of Participants with Skeletal-Related Event (SRE)
timeFrame: Up to Approximately 5 Years
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Main /ID# 261434
state: Alabama
city: Phoenix
country: United States
facility: Mayo Clinic Hospital - Phoenix /ID# 263326
state: Arizona
city: Berkeley
country: United States
facility: Alta Bates Summit Medical Center for Research /ID# 261438
state: California
city: Fullerton
country: United States
facility: Providence - St. Jude Medical Center /ID# 262031
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center /ID# 261008
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Hospital Jacksonville /ID# 263324
state: Florida
city: Jacksonville
country: United States
facility: Cancer Specialists of North Florida - Jacksonville - AC Skinner Parkway /ID# 246230
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University /ID# 262525
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago /ID# 246349
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic /ID# 262266
state: Illinois
city: Bethesda
country: United States
facility: Center for Cancer and Blood Disorders /ID# 263637
state: Maryland
city: Boston
country: United States
facility: Dana-Farber Cancer Institute /ID# 261554
state: Massachusetts
city: Ann Arbor
country: United States
facility: Regents of the University of Michigan /ID# 261577
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute - Detroit /ID# 266298
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital /ID# 262704
state: Michigan
city: Lansing
country: United States
facility: Barbara Ann Karmanos Cancer Institute - McLaren Greater Lansing /ID# 259891
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 246228
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Hospital /ID# 261553
state: Missouri
city: Bay Shore
country: United States
facility: New York Cancer & Blood Specialists - Bay Shore /ID# 261524
state: New York
city: Bronx
country: United States
facility: Eastchester Center for Cancer Care /ID# 262952
state: New York
city: New Hyde Park
country: United States
facility: New York Cancer & Blood Specialists - Lake Success Medical Oncology /ID# 262953
state: New York
city: New York
country: United States
facility: New York Cancer and Blood Specialists - New York /ID# 262951
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina /ID# 259854
state: North Carolina
city: Charlotte
country: United States
facility: Levine Cancer Institute /ID# 246199
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center /ID# 259694
state: North Carolina
city: Cincinnati
country: United States
facility: University Of Cincinnati Medical Center /ID# 246415
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus /ID# 246183
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina /ID# 259692
state: South Carolina
city: Memphis
country: United States
facility: Baptist Memorial Hospital /ID# 270910
state: Tennessee
city: Memphis
country: United States
facility: The West Clinic /ID# 262444
state: Tennessee
city: Fairfax
country: United States
facility: Virginia Cancer Specialists - Fairfax /ID# 262792
state: Virginia
city: Richmond
country: United States
facility: VCU Massey Cancer Center: Dalton Oncology Clinic /ID# 261944
state: Virginia
city: Kogarah
country: Australia
facility: St George Hospital /ID# 261806
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital /ID# 262159
state: New South Wales
city: Waratah
country: Australia
facility: Calvary Mater Newcastle /ID# 261804
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital /ID# 261810
state: Queensland
city: Clayton
country: Australia
facility: Monash Health - Monash Medical Centre /ID# 262158
state: Victoria
city: Fitzroy Melbourne
country: Australia
facility: St Vincent's Hospital Melbourne /ID# 261808
state: Victoria
city: Melbourne
country: Australia
facility: Box Hill Hospital /ID# 262784
state: Victoria
city: Krems an der Donau
country: Austria
facility: Universitaetsklinikum Krems /ID# 261509
state: Niederoesterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen /ID# 245609
state: Oberoesterreich
city: Graz
country: Austria
facility: Medizinische Universitaet Graz /ID# 261908
state: Steiermark
city: Vienna
country: Austria
facility: Klinik Ottakring /ID# 245829
state: Wien
city: Brasschaat
country: Belgium
facility: Algemeen Ziekenhuis klina /ID# 260856
state: Antwerpen
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge /ID# 245345
city: Toronto
country: Canada
facility: University Health Network_Princess Margaret Cancer Centre /ID# 261566
state: Ontario
city: Beijing
country: China
facility: Beijing Chaoyang Hospital,Capital Medical University /ID# 245533
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital (East) - Dongdan Campus /ID# 245545
state: Beijing
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital /ID# 245558
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center /ID# 245542
state: Guangdong
city: Zhengzhou
country: China
facility: People's Hospital of Henan Province /ID# 260918
state: Henan
city: Zhengzhou
country: China
facility: Henan Cancer Hospital /ID# 245536
state: Henan
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technol /ID# 245549
state: Hubei
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University /ID# 245563
state: Jiangsu
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University /ID# 245544
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University /ID# 245537
state: Jiangxi
city: Shenyang
country: China
facility: The First Hospital of China Medical University /ID# 245547
state: Liaoning
city: Shanghai
country: China
facility: Shanghai Tongji Hospital /ID# 245539
state: Shanghai
city: Tianjin
country: China
facility: Institute of Hematology and Blood Diseases Hospital /ID# 265702
state: Tianjin
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital /ID# 260851
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 260883
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital Zhejiang University School of Medicine /ID# 260882
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University /ID# 245550
state: Zhejiang
city: Brno
country: Czechia
facility: Fakultní Nemocnice Brno - Jihlavská /ID# 245689
state: Brno-mesto
city: Hradec Králové
country: Czechia
facility: Fakultní nemocnice Hradec Králové - Sokolská /ID# 245690
state: Hradec Kralove
city: Ostrava
country: Czechia
facility: Fakultni Nemocnice Ostrava /ID# 245686
state: Ostrava-mesto
city: Praha
country: Czechia
facility: Vseobecna fakultni nemocnice v Praze /ID# 245691
city: Odense
country: Denmark
facility: Odense University Hospital /ID# 260924
state: Syddanmark
city: Vejle
country: Denmark
facility: Sygehus Lillebalt, Vejle /ID# 260923
state: Syddanmark
city: St Quentin CEDEX
country: France
facility: Ch Saint Quentin /Id# 261856
state: Aisne
city: Le Mans CEDEX 9
country: France
facility: Centre Hospitalier du Mans /ID# 261852
state: Sarthe
city: Avignon CEDEX 9
country: France
facility: CH Henri Duffaut /ID# 261844
state: Vaucluse
city: Orléans
country: France
facility: Centre Hospitalier Régional d'Orléans - Hôpital de la Source /ID# 261854
city: Freiburg
country: Germany
facility: Universitaetsklinikum Freiburg /ID# 262147
state: Baden-Wuerttemberg
city: Berlin
country: Germany
facility: Charite Universitaetsklinikum Berlin - Campus Benjamin Franklin /ID# 260689
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf /ID# 260651
city: Athens
country: Greece
facility: Alexandra General Hospital /ID# 240591
state: Attiki
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 240592
state: Attiki
city: Athens
country: Greece
facility: General Hospital of Athens Evaggelismos and Ophthalmiatrio of Athens Polyclinic /ID# 240596
city: Thessaloniki
country: Greece
facility: General University Hospital of Thessaloniki AXEPA /ID# 240595
city: Gyor
country: Hungary
facility: Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz /ID# 261648
state: Gyor-Moson-Sopron
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 261647
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz Orszagos Hematologiai es Infektologiai Intezet /ID# 261646
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 245497
state: Tel-Aviv
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 245495
state: Tel-Aviv
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center /ID# 245681
state: Yerushalayim
city: Petah Tikva
country: Israel
facility: Rabin Medical Center /ID# 245498
city: Legnano
country: Italy
facility: ASST Ovest Milanese /ID# 256813
state: Milano
city: Torino
country: Italy
facility: A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 256808
state: Piemonte
city: Rome
country: Italy
facility: Azienda Ospedaliero-Universitaria Policlinico Umberto I /ID# 256810
state: Roma
city: Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria delle Marche /ID# 256812
city: Catania
country: Italy
facility: AOU Policlinico G. Rodolico - San Marco /ID# 256814
city: Anjo
country: Japan
facility: Anjo Kosei Hospital /ID# 263434
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital /ID# 263320
state: Aichi
city: Chiba-shi
country: Japan
facility: Chiba University Hospital /ID# 262006
state: Chiba
city: Yoshida-gun
country: Japan
facility: University of Fukui Hospital /ID# 264222
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 264704
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Gifu Municipal Hospital /ID# 263321
state: Gifu
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital /ID# 262580
state: Gunma
city: Fukuyama
country: Japan
facility: Chugoku Central Hospital /ID# 263431
state: Hiroshima
city: Amagasaki
country: Japan
facility: Hyogo Prefectural Amagasaki General Medical Center /ID# 265696
state: Hyogo
city: Kyoto-shi
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine /ID# 262585
state: Kyoto
city: Natori
country: Japan
facility: Miyagi Cancer Center /ID# 265094
state: Miyagi
city: Naha
country: Japan
facility: Naha City Hospital /ID# 263972
state: Okinawa
city: Suita-shi
country: Japan
facility: The University of Osaka Hospital /ID# 263974
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center /ID# 262586
state: Saitama
city: Shibuya-ku
country: Japan
facility: Japanese Red Cross Medical Center /ID# 261717
state: Tokyo
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital /ID# 245491
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center /ID# 245492
state: Seoul Teugbyeolsi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Marys Hospital /ID# 245493
state: Seoul Teugbyeolsi
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital /ID# 245490
state: Ulsan Gwang Yeogsi
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Severance Hospital /ID# 245489
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny We Wrocławiu /ID# 260172
state: Dolnoslaskie
city: Lublin
country: Poland
facility: Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie /ID# 260168
state: Lubelskie
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne /ID# 260169
state: Pomorskie
city: Lisbon
country: Portugal
facility: Fundacao Champalimaud /ID# 246258
state: Lisboa
city: Lisboa
country: Portugal
facility: Unidade Local de Saude de Santa Maria, EPE /ID# 246255
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia do Porto Francisco Gentil, EPE /ID# 246257
city: Pretoria
country: South Africa
facility: Alberts Cellular Therapy /ID# 245725
state: Gauteng
city: Cape Town
country: South Africa
facility: Constantiaberg Haematology /ID# 261320
state: Western Cape
city: Kuilsrivier
country: South Africa
facility: Haemalife Inc. /ID# 245724
state: Western Cape
city: Badalona
country: Spain
facility: Instituto Catalan de Oncologia (ICO) Badalona /ID# 246398
state: Barcelona
city: Orense
country: Spain
facility: Complejo Hospitalario Universitario Ourense /ID# 246400
state: Ourense
city: Leon
country: Spain
facility: Hospital de Leon /ID# 261624
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 246401
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca /ID# 262218
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 261625
city: Helsingborg
country: Sweden
facility: Helsingborgs Lasarett /ID# 262513
state: Skane Lan
city: Uddevalla
country: Sweden
facility: Uddevalla sjukhus /ID# 262034
state: Vastra Gotalands Lan
city: Falun
country: Sweden
facility: Falu Lasarett /ID# 262231
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital /ID# 245482
state: Taipei
city: Taichung
country: Taiwan
facility: China Medical University Hospital /ID# 245483
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital /ID# 261142
city: Ankara
country: Turkey
facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi /ID# 261672
city: Antalya
country: Turkey
facility: Antalya Egitim Ve Arastirma Hastanesi /ID# 261674
city: Edirne, Istanbul
country: Turkey
facility: Trakya University Medical Facu /ID# 261673
city: Şişli
country: Turkey
facility: Istanbul Florence Nightingale Hospital /ID# 271543
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital /ID# 261104
state: Cambridgeshire
city: London
country: United Kingdom
facility: Guys and St Thomas NHS Foundation Trust /ID# 262488
state: Greater London
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital /ID# 261105
state: Nottinghamshire
city: Edinburgh
country: United Kingdom
facility: NHS Lothian /ID# 261106
city: Manchester
country: United Kingdom
facility: The Christie Hospital /ID# 261102
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: