Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (RRMM)

Multiple Myeloma Clinical Trial

— EXCALIBER-RRMM  

Official title:

A Phase 3, Two-Stage, Randomized, Multicenter, Open-label Study Comparing Iberdomide, Daratumumab and Dexamethasone (IberDd) Versus Daratumumab, Bortezomib, and Dexamethasone (DVd) in Subjects With Relapsed or Refractory Multiple Myeloma (RRMM)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04975997
• Other study ID #: CC-220-MM-002
• Secondary ID: U1111-1260-28722
• Status: Recruiting
• Phase: Phase 3
• Start date: June 23, 2022
• Est. completion date: June 25, 2032

Study information

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

Clinical Trial Summary

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM).

Description:

This is a multicenter, two-stage, randomized, controlled, open-label, Phase 3 study comparing the efficacy and safety of iberdomide in combination with dexamethasone and daratumumab (IberDd) versus daratumumab, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (RRMM). Approximately 200 patients randomized in stage 1 to one of three iberdomide dose levels of 1, 1.3, or 1.6 mg in combination with daratumumab and dexamethasone (Treatment Arms A1, A2, or A3), or to the DVd comparator arm (Treatment Arm B).

In Stage 2 of the study, approximately 664 additional subjects will be randomized 1:1 between 2 treatment arms:

• Approximately 332 subjects will be randomized to receive Treatment Arm A (IberDd)

• Approximately 332 subjects will be randomized to receive Treatment Arm B (DVd)

Participants in both treatment arms will continue to receive treatment until confirmed progressive disease (PD), unacceptable toxicity or withdrawal of consent. To ensure accuracy and completeness of the primary endpoint assessment of progression-free survival (PFS), participants who permanently discontinue study treatment for any reason, other than confirmed PD or withdrawal of consent, will continue to be followed for disease assessment.

The study will be conducted in compliance with International Council for Harmonisation (ICH) and Good Clinical Practices (GCPs).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 864
• Est. completion date: June 25, 2032
• Est. primary completion date: March 18, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• Documented diagnosis of multiple myeloma (MM) and measurable disease.

• Received 1 to 2 prior lines of anti-myeloma therapy.

• Must have documented disease progression during or after their last anti-myeloma regimen.

• Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2.

Exclusion Criteria

• Any condition that confounds the ability to interpret data from the study.

• Has plasma cell leukemia, Waldenstrom's macroglobulinemia or POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or clinically significant amyloidosis.

• Known central nervous system involvement with MM.

• Prior therapy with iberdomide.

• Other protocol-defined Inclusion/Exclusion criteria apply.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Dexamethasone
Oral dexamethasone 40mg on days 1, 8, 15, 22 of a 28-day cycle
• Daratumumab
Subcutaneous Daratumumab 1800mg on Days 1, 8, 15 and 22 for Cycles 1 to 2, on Days 1 and 15 for Cycles 3 to 6, and then on Day 1 for Cycle 7 of a 28-day cycle
• Bortezomib
Subcutaneous Bortezomib 1.3 mg/m2 on Days 1, 4, 8 and 11 of each 21-day cycle for a total of 8 cycles.
• Iberdomide
Oral Iberdomide 1.0mg on Days 1 to 21 of a 28-day cycle
• Iberdomide
Oral Iberdomide 1.3mg on Days 1 to 21 of a 28-day cycle
• Iberdomide
Oral Iberdomide 1.6mg on Days 1 to 21 of a 28-day cycle

Locations

Country	Name	City	State
Argentina	Local Institution - 080	Ciudad Autanoma De Buenos Aires	Buenos Aires
Argentina	Local Institution - 083	Villa Elisa	Buenos Aires
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Flinders Medical Centre, Dept Of Oncology	Bedford Park	South Australia
Australia	Sunshine Coast University Hospital	Birtinya	Queensland
Australia	Royal Prince Alfred Hospital	Camperdown
Australia	Monash Medical Centre	Clayton	Victoria
Australia	The Townsville Hospital	Douglas	Queensland
Australia	Epworth Hospital	East Melbourne	Victoria
Australia	St Vincent's Hospital Melbourne	Fitzroy
Australia	The Canberra Hospital	Garran
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Fiona Stanley Hospital	Murdoch	Western Australia
Australia	Perth Blood Institute	West Perth	Western Australia
Austria	Medical University of Graz	Graz
Austria	Krankenhaus Der Barmherzigen Schwestern Linz	Linz
Austria	Universitatsklinik der PMU	Salzburg
Austria	University Hospital St. Poelten	St Polten
Austria	Medizinische Universität Wien	Vienna
Austria	Local Institution - 151	Wien
Austria	Local Institution - 157	Wien
Belgium	AZ Sint-Jan AV Brugge	Brugge
Belgium	Cliniques Universitaires Saint-Luc	Bruxelles
Brazil	Local Institution - 051	Barretos	São Paulo
Brazil	Local Institution - 056	Curitiba	Parana
Brazil	Local Institution - 054	Jau	SAO Paulo
Brazil	Local Institution - 050	Porto Alegre	RS
Brazil	Local Institution - 058	Porto Alegre	RIO Grande DO SUL
Brazil	Instituto COI de Pesquisa, Educacao e Gestao	Rio de Janeiro
Brazil	Clinica Sao Germano	Sao Paulo
Brazil	Fundacao Antonio Prudente - AC Camargo Cancer Center	Sao Paulo
Brazil	Local Institution - 055	Sao Paulo
Canada	Local Institution - 111	Calgary	Alberta
Canada	Local Institution - 103	Edmonton	Alberta
Canada	Queen Elizabeth Ii Health Sciences Centre	Halifax	Nova Scotia
Canada	Local Institution - 109	Ottawa	Quebec
Canada	CHU de Quebec-Universite Laval	Quebec
Canada	Local Institution - 104	Saint John	New Brunswick
Canada	Local Institution - 107	Saskatoon	Saskatchewan
Canada	Memorial University of NewfoundlandDr. H Bliss Murphy Cancer Center	St John's	Newfoundland and Labrador
Canada	BC Cancer Agency, Fraser Valley Center	Surrey	British Columbia
China	Beijing Boren Hospital	Beijing
China	Beijing Peking Union Medical College Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	First Hospital of Jilin University	Changchun
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Beijing Chaoyang Hospital Capital Medical University	Chaoyang District
China	Guangdong General Hospital	Guangzhou
China	Sun Yat-sen University Cancer Center	Guangzhou
China	The First Affiliated Hospital of Medical School of Zhejiang University	Hangzhou City
China	The First Affiliated Hospital of Medical School of Zhejiang University	Hangzhou, Zhejiang
China	The First Affiliated Hospital Of Harbin Medical University	Harbin
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University	Nanjing
China	Ruijin Hospital Shanghai Jiaotong University	Shanghai
China	Shanghai Fourth People's hospital	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai
China	Shengjing Hospital Of China Medical University	Shenyang
China	The First Affiliated Hospital Of Soochow University	Suzhu
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Institution of Hematology & Hospital of Blood Disease, Chinese Academy of Medical Sciences	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology	Wuhan
China	Local Institution - 143	Xian	Shaanxi
China	Xijing Hospital	Xian
China	Henan Cancer Hospital	Zhengzhou
Czechia	Fakultni nemocnice Brno	Brno
Czechia	Fakultni nemocnice Ostrava	Ostrava-Poruba
Czechia	Vseobecna Fakultni Nemocnice V Praze	Prague 2
Denmark	Aalborg Universitetshospital	Aalborg
Denmark	Odense University Hospital	Odense
Denmark	Sealand University Hospital	Roskilde
Finland	Helsinki University Central Hospital	Helsinki
Finland	Oulu University Hospital	Oulu
Finland	Turku University Hospital	Turku
France	CH Argenteuil Victor Dupouy	Argenteuil
France	Centre Hospitalier Departemental de Vendee	La Roche -Sur-Yon - Cedex 9
France	CHRU de Lille France	Lille Cedex
France	CHU de Nancy - Hopital Brabois- Service d'Hematologie et DE medecine Interne, 7eme etage	Nancy Cedex
France	Local Institution - 454	Nantes
France	Hopital Saint Antoine	Paris
France	Hopital Saint-Louis	Paris Cedex
France	Chu Bordeaux	Pessac
France	Centre Henri Becquerel	Rouen
France	Institut Universitaire du Cancer de Toulouse - Oncopole	Toulouse Cedex 9
Germany	Klinikum der Johann Wolfgang Goethe Universitat	Frankfurt am Main
Germany	Asklepios Altona	Hamburg
Germany	Universitaetsklinik Hamburg - Eppendorf	Hamburg
Germany	Universitaetsklinikum Heidelberg	Heidelberg
Germany	Uniklinik Schleswig-Holstein Kiel	Kiel	Schleswig-Holstein
Germany	Universitatsklinikum Schleswig-Holstein	Lubeck
Greece	Alexandra General Hospital Of Athens	Athens
Greece	Olympion Clinic	Patra	Achaia
Greece	University General Hospital of Patras	Patras	Achaea
Greece	Georgios Papanikolaou General Hospital of Thessaloniki	Thessaloniki
Greece	Theagenio Anticancer Hospital of Thessaloniki	Thessaloniki
India	M. S. Ramaiah Medical College And Hospital	Bangalore	Karnataka
India	Local Institution - 934	Ernakulam	Kerala
India	Yashoda Hospitals Hitec City	Hyderabad	Andhra Pradesh
India	Nil Ratan Sircar Medical College and Hospital	Kolkata	West Bengal
India	Mumbai Oncocare Centre Vile Parle	Mumbai	Maharashtra
India	Jawaharlal Institute of Postgraduate Medical Education & Research	Pondicherry
Ireland	Cork University Hospital	Cork
Ireland	Beaumont Hospital	Dublin 9
Ireland	University Hospital Galway	Galway
Israel	Local Institution - 874	Afula	HaZafon
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medical Center	Jerusalem
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Israel	Sheba Medical Center - PPDS	Tel Hashomer
Italy	A.O.U. di Bologna Policlinico S.Orsola-Malpighi	Bologna
Italy	Università di Catania- Presidio Ospedaliero Ferrarotto	Catania
Italy	A.O.U. San Martino	Genova
Italy	Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milano
Italy	Local Institution - 407	Milano
Italy	A.O.U. Maggiore della Carit	Novara
Italy	Fondazione Irccs Policlinico San Matteo	Pavia
Italy	Azienda Ospedaliera Universitaria Pisana	Pisa
Italy	Local Institution - 405	Reggio Calabria
Italy	Local Institution - 413	Reggio Emilia
Italy	Azienda Ospedaliera S. Andrea - Università La Sapienza	Roma
Italy	Local Institution - 415	Roma	Lazio
Italy	IRCCS Ospedale Casa Sollievo della Sofferenza	San Giovanni Rotondo FG
Italy	Local Institution - 409	Terni
Italy	Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine	Udine
Japan	Aomori Prefectural Central Hospital	Aomori
Japan	Chiba Cancer Center	Chiba
Japan	University of Yamanashi Hospital	Chuo-shi	Yamanashi
Japan	National Hospital Organization Kyushu Medical Center	Fukuoka
Japan	Local Institution - 917	Higashi-Ibaraki-gun	Ibaraki
Japan	Kameda General Hospital	Kamogawa
Japan	University Hospital,Kyoto Prefectural University of Medicine	Kyoto-City
Japan	Matsuyama Red Cross Hospital	Matsuyama	Ehime
Japan	Aichi Cancer Center	Nagoya
Japan	Nagoya City University Hospital	Nagoya
Japan	Local Institution - 920	Nerima-ku	Tokyo
Japan	Okayama Medical Center	Okayama
Japan	Osaka Metropolitan university Hospital	Osaka
Japan	Kindai University Hospital- Osakasayama Campus	Osaka-Sayama
Japan	Sapporo Hokuyu Hospital	Sapporo
Japan	Tohoku University Hospital	Sendai
Japan	Japan Red Cross Medical Center	Shibuya-ku
Japan	Local Institution - 919	Shimotsuga	Tochigi
Japan	Local Institution - 918	Shinagawa-ku	Tokyo
Japan	NTT Medical Center Tokyo	Shinagawa-ku, Tokyo
Japan	Toyohashi Municipal Hospital	Toyohashi
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	National Cancer Center	Gyeonggi-do
Korea, Republic of	Hwasun Chonnam National University Hospital	Hwasun-gun
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	The Catholic University of Korea Seoul - Saint Mary's Hospital	Seoul
Mexico	Local Institution - 183	Guadalajara	Jalisco
Mexico	Local Institution - 181	La Raza
Mexico	Local Institution - 180	Mexico City
Mexico	Local Institution - 182	Mexico City	Distrito Federal
Netherlands	Vrije Universiteit Medisch Centrum (Vumc)	Amsterdam
Netherlands	Hagaziekenhuis	Den Haag
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht	Zuid-Holland
Norway	Haukeland University Hospital	Bergen
Norway	Oslo Myeloma Center - PPDS	Oslo
Norway	St. Olav's University Hospital	Trondheim
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bialystok	Podlaskie
Poland	Szpital Uniwersytecki W Krakowie	Krakow
Poland	Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu	Nowy Sacz
Poland	Szpital Kliniczny im. H.Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu	Poznan
Poland	Specjalistyczny Szpital im. dra Alfreda Sokolowskiego	Walbrzych
Poland	Centrum Onkologii-Instytut im.Marii Sklodowskiej-Curie	Warszawa
Portugal	Centro Hospital e Universitario de Coimbra	Coimbra
Portugal	Champalimaud Cancer Center	Lisboa
Portugal	Instituto Portugues de Oncologia de Lisboa, Francisco Gentil	Lisboa
Portugal	Centro Hospitalar de Sao Joao, EPE	Porto
Portugal	Ipo Instituto Portugues De Oncologia Porto	Porto
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitari Germans Trias I Pujol	Barcelona
Spain	Hospital Universitario Vall D hebron - PPDS	Barcelona
Spain	Hospital San Pedro de Alcántara	Caceres
Spain	Hospital Universitario Reina Sofia	Cordoba
Spain	Clinica Universidad de Navarra-Madrid	Madrid
Spain	Hospital De La Princesa	Madrid
Spain	Hospital Universitario Fundacion Jimenez Diaz	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Virgen De La Victoria	Malaga
Spain	Hospital Universitario Virgen de La Arrixaca	Murcia
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca	Salamanca
Spain	Hospital Clinico Universitario De Santiago	Santiago de Compostela
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza
Sweden	Sodra Alvsborgs Sjukhus Boras	Boras
Sweden	Helsingborgs Lasarett	Helsingborg
Switzerland	Kantonsspital Graubunden	Chur
Switzerland	Kantonsspital St. GallenBereich OnkologieHamatologie	St. Gallen
Taiwan	Chang Gung Medical Foundation, Kaohsiung Memorial Hospital	Niao-Sung Hsiang Kaohsiung County
Taiwan	Taichung Veterans General Hospital	Taichung
Taiwan	China Medical University Hospital	Taichung City
Taiwan	National Cheng Kung University Hospital	Tainan, Taiana
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	National Taiwan University Hospital	Taipei, Zhongzheng Dist.
Taiwan	Chang Gung Medical Foundation, Linkou Memorial Hospital	Taoyuan City
Turkey	Ankara University Medical Faculty	Ankara
Turkey	Dokuz Eylul University Medical Faculty	Balçova	Izmir
Turkey	Ege University Medical Faculty	Bornova	Izmir
Turkey	Gazi University Faculty Of Medicine	Gaziantep
Turkey	Liv Hospital Ankara	Kavaklidere	Ankara
Turkey	Erciyes University Medical Faculty	Kayseri
Turkey	Marmara University Pendik Training and Research Hospital	Pendik	Istanbul
Turkey	Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi	Samsun	Kurupelit
Turkey	Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi	Yenimahalle	Ankara
United Kingdom	Belfast City Hospital	Belfast Northern Ireland
United Kingdom	University Hospitals Birmingham NHS Foundation Trust - Queen Elizabeth Hospital	Birmingham
United Kingdom	Kent and Canterbury Hospital	Canterbury Kent
United Kingdom	Local Institution - 704	Lancashire Blackpool
United Kingdom	Guy's and St Thomas' Hospital - London	London
United Kingdom	University College London Hospitals NHS Foundation Trust - University College Hospital	London
United Kingdom	Local Institution - 702	Nottingham	Nottinghamshire
United Kingdom	Oxford University Hospitals NHS Foundation Trust-Churchill Hospital-Cancer and Haematology Centre	Oxford
United Kingdom	Local Institution - 711	Portsmouth
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton
United Kingdom	New Cross Hospital	Wolverhampton
United States	Christus St Francis Cabrini Hospital	Alexandria	Louisiana
United States	Emory University School of Medicine	Atlanta	Georgia
United States	Local Institution - 027	Baton Rouge	Louisiana
United States	Local Institution - 682	Baton Rouge	Louisiana
United States	Local Institution - 042	Bay Shore	New York
United States	Center For Cancer And Blood Disorders	Bethesda	Maryland
United States	St. Vincent Frontier Cancer Center	Billings	Montana
United States	Local Institution - 010	Boston	Massachusetts
United States	Tennessee Oncology	Chattanooga	Tennessee
United States	TriHealth, Good Samaritan Hospital	Cincinnati	Ohio
United States	Cleveland Clinic - Taussig Cancer Institute	Cleveland	Ohio
United States	MetroHealth Medical Center - Main Campus	Cleveland	Ohio
United States	Ohio Health Corporation	Columbus	Ohio
United States	Local Institution - 683	Corona	California
United States	Duke University Hospital	Durham	North Carolina
United States	Local Institution - 029	Fort Myers	Florida
United States	Compassionate Cancer Care Medical Group Inc.	Fountain Valley	California
United States	Penn State Hershey Cancer Institute	Hershey	Pennsylvania
United States	Genesis cancer and Blood Institute (GCBI) - Sarah Cannon	Hot Springs	Arkansas
United States	Baptist MD Anderson Cancer Center	Jacksonville	Florida
United States	HCA Midwest Health	Kansas City	Missouri
United States	USC Norris Comprehensive Cancer Center	Los Angeles	California
United States	Norton Cancer Institute - St. Matthews Campus	Louisville	Kentucky
United States	University Of Wisconsin	Madison	Wisconsin
United States	Sarah Cannon Research Institute (SCRI)	Nashville	Tennessee
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Local Institution - 684	Newport	California
United States	Oregon Health and Science University	Portland	Oregon
United States	Local Institution - 028	Saint Petersburg	Florida
United States	Local Institution - 015	Summit	New Jersey
United States	BRCR Global	Tamarac	Florida
United States	Oklahoma Cancer Specialists and Research Institute	Tulsa	Oklahoma
United States	Local Institution - 034	West Palm Beach	Florida
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)	To compare the efficacy of iberdomide, daratumumab, and dexamethasone (IberDd) to that of daratumumab, bortezomib, and dexamethasone (DVd) in terms of progression-free survival (PFS) in participants with relapsed or refractory multiple myeloma (RRMM).	Up to approximately 5 years
Secondary	Overall Survival (OS)	To evaluate clinical efficacy in terms of overall survival (OS) in participants with relapsed or refractory multiple myeloma (RRMM) treated with iberdomide, daratumumab, and dexamethasone (IberDd) compared to daratumumab, bortezomib, and dexamethasone (DVd).	Up to approximately 5 years
Secondary	Minimal Residual Disease (MRD) negativity rate	Proportion of participants who achieve complete response (CR) or better and are MRD negative (defined at a sensitivity of a minimum of 1 in 105 nucleated cells by next generation flow cytometry).	Up to approximately 5 years
Secondary	Overall Response Rate (ORR)	Calculated as percentage of participants who achieve best response of partial response (PR) or better according to the IMWG Uniform Response Criteria for multiple myeloma.	Up to approximately 5 years
Secondary	Time to response (TTR)	Time from randomization to the first documentation of response (PR or better).	Up to approximately 5 years
Secondary	Duration of Response (DoR)	Time from the first documentation of response (PR or better) to the first documentation of progressive disease (PD) or death due to any cause, whichever occurs first.	Up to approximately 5 years
Secondary	Time to Progression (TTP)	The time from randomization to the first documented disease progression.	Up to approximately 5 years
Secondary	Time to Next Treatment (TTNT)	Time from randomization to the start of the next antimyeloma treatment.	Up to approximately 5 years
Secondary	Progression-free Survival 2 (PFS2)	Time from randomization to progression on the next anti-myeloma treatment or death due to any cause, whichever occurs first.	Up to approximately 5 years
Secondary	Safety	Type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to study treatment.	Up to approximately 5 years
Secondary	European Organization for Research and Treatment of Cancer - Quality of Life C30 Questionnaire (EORTC QLQ-C30)	Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ-C30.	Up to approximately 5 years
Secondary	European Quality of Life Multiple Myeloma Module (EORTC QLQ-MY20)	EORTC QLQ-MY20 is a 20-item myeloma module intended for use among participants varying in disease stage and treatment modality. Mean changes from baseline in subscale scores in subject-reported health related quality of life outcomes and multiple myeloma-related symptoms as measured by the EORTC QLQ- MY20.	Up to approximately 5 years
Secondary	Recommended iberdomide dose for Stage 2		Up to approximately 1 year
Secondary	Area under the plasma concentration-time curve from time zero to tau (AUC(TAU))		Up to approximately 1 year
Secondary	Maximum plasma concentration (Cmax)		Up to approximately 1 year
Secondary	Time to maximum plasma concentration (Tmax)		Up to approximately 1 year

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting