MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma

Multiple Myeloma Clinical Trial

— MAGNETISMM-5  

Official title:

AN OPEN-LABEL, 3-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) MONOTHERAPY AND ELRANATAMAB + DARATUMUMAB VERSUS DARATUMUMAB + POMALIDOMIDE + DEXAMETHASONE IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR LINE OF THERAPY INCLUDING LENALIDOMIDE AND A PROTEASOME INHIBITOR

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05020236
• Other study ID #: C1071005
• Secondary ID: 2021-000044-22MA
• Status: Recruiting
• Phase: Phase 3
• Start date: October 4, 2021
• Est. completion date: May 31, 2027

Study information

• Verified date: June 2024
• Source: Pfizer
• Contact: Pfizer CT.gov Call Center
• Phone: 1-800-718-1021
• Email: ClinicalTrials.gov_Inquiries[@]pfizer.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate whether the BCMA-CD3 bispecific antibody elranatamab, alone and/or in combination with the anti-CD38 monoclonal antibody, daratumumab, can provide more benefit to people with multiple myeloma compared to a combination therapy including daratumumab, pomalidomide, and dexamethasone. People with multiple myeloma who have received previous treatment including lenalidomide and a proteasome inhibitor will be enrolled in the study. Part 1 of the study will assess the safety and activity of different doses of elranatamab in combination with daratumumab. People participating in Part 2 of the study will be randomly assigned to receive either elranatamab alone, elranatamab plus daratumumab, or daratumumab, pomalidomide, and dexamethasone. Part 2 will compare the safety and activity of (1) elranatamab alone compared to daratumumab, pomalidomide, and dexamethasone, and (2) elranatamab plus daratumumab compared to daratumumab, pomalidomide, and dexamethasone. Participants in all parts of the study will receive study treatment until their disease progresses, they experience unacceptable side effects, or they choose to no longer participate in the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 761
• Est. completion date: May 31, 2027
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Prior diagnosis of multiple myeloma as defined by IMWG criteria (Rajkumar et al, 2014).
• Measurable disease based on IMWG criteria as defined by at least 1 of the following:
• Serum M-protein =0.5 g/dL.
• Urinary M-protein excretion =200 mg/24 hours.
• Serum immunoglobulin FLC =10 mg/dL (=100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
• Prior anti-multiple myeloma therapy including treatment with lenalidomide and a proteasome inhibitor.
• ECOG performance status =2.
• Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade =1.
• Not pregnant and willing to use contraception.

Exclusion Criteria:

• Smoldering multiple myeloma.
• Plasma cell leukemia.
• Amyloidosis.
• POEMS Syndrome.
• Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
• Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
• Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
• Previous treatment with a BCMA-directed therapy.
• Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study.
• Live attenuated vaccine within 4 weeks of the first dose of study intervention.
• Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Elranatamab
subcutaneous
• Daratumumab
Daratumumab / hyaluronidase, subcutaneous
• Pomalidomide
oral
• Dexamethasone
oral

Locations

Country	Name	City	State
Argentina	Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming)	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	FUNDALEU - Fundacion para combatir la Leucemia	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	FUNDALEU -Fundación para combatir la leucemia	Ciudad Autónoma de Buenos Aires	Buenos Aires
Argentina	Hospital Universitario Austral	Derqui, Pilar	Buenos Aires
Argentina	Hospital Italiano de La Plata	La Plata	Buenos Aires
Argentina	Sanatorio de La Mujer	Rosario	Santa FE
Australia	Pindara Private Hospital	Benowa	Queensland
Australia	Gallipoli Medical Research Ltd	Brisbane	Queensland
Australia	QScan Radiology Clinics	Clayfield	Queensland
Australia	Epworth Freemasons	East Melbourne	Victoria
Australia	St Vincent's Hospital (Melbourne)	Fitzroy	Victoria
Australia	Barwon Health	Geelong	Victoria
Australia	Gallipoli Medical Research Foundation	Greenslopes	Queensland
Australia	Greenslopes Private Hospital	Greenslopes	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Linear Clinical Research	Nedlands	Western Australia
Australia	Linear Clinical Research	Perth	Western Australia
Australia	Epworth Healthcare	Richmond	Victoria
Australia	Slade Pharmacy	Richmond	Victoria
Australia	Princess Alexandra Hospital	Woolloongabba	Queensland
Austria	Universitätsklinik für Innere Medizin V Innsbruck	Innsbruck
Austria	Universitätsklinikum Krems	Krems	Niederösterreich
Austria	Uniklinikum Salzburg	Salzburg
Austria	Klinik Ottakring	Vienna	Wien
Austria	Medizinische Universität Wien	Wien
Belgium	Grand Hôpital de Charleroi	Charleroi	Hainaut
Belgium	CHU UCL Namur (site Godinne)	Yvoir	Namur
Brazil	Centro de Pesquisa Clínica - Área Administrativa	Porto Alegre	RIO Grande DO SUL
Brazil	Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa	Porto Alegre	RIO Grande DO SUL
Brazil	Hospital Mae de Deus	Porto Alegre	RIO Grande DO SUL
Brazil	Hospital Américas Medical City	Rio de Janeiro
Brazil	Instituto de Educação, Pesquisa e Gestão em Saúde	Rio de Janeiro
Brazil	Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador	Salvador,	Bahia
Brazil	BP - A Beneficencia Portuguesa de São Paulo	Sao Paulo	SÃO Paulo
Brazil	Clínica Médica São Germano S/S Ltda	São Paulo
Brazil	ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis	São Paulo
Brazil	Hospital Japonês Santa Cruz	São Paulo
Brazil	HU UNIFESP / SPDM - Hospital São Paulo	São Paulo
Brazil	IDOR Ensino e Pesquisa	São Paulo
Brazil	Instituto D'Or de Pesquisa e Ensino (IDOR)	São Paulo
Brazil	Instituto D'Or de Pesquisa e Ensino (IDOR)	São Paulo
Brazil	Universidade Federal de Sao Paulo	São Paulo
Brazil	Clínica Médica São Germano LTDA	SP	SÃO Paulo
Canada	Tom Baker Cancer Center	Calgary	Alberta
Canada	Cross Cancer Institute	Edmonton	Alberta
Canada	QEII Health Sciences Centre - Victoria General Site	Halifax	Nova Scotia
Canada	Queen Elizabeth II Health Science Centre	Halifax	Nova Scotia
Canada	Hamilton Health Sciences-Juravinski Cancer Centre	Hamilton	Ontario
Canada	Jewish General Hospital	Montreal	Quebec
Canada	CIUSSS de l'Est-de-l'Île-de-Montréal	Montréal	Quebec
Canada	Saskatoon Cancer Center	Saskatoon	Saskatchewan
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
China	Beijing Boren Hospital	Beijing
China	Beijing Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	Jilin Province Cancer Hospital	Changchun	Jilin
China	The First Hospital of Jilin University	Changchun	Jilin
China	Chongqing University Cancer Hospital	Chongqing
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Jinan Central Hospital	Jinan	Shandong
China	Jinan Central Hospital	Jinan
China	Jinan Central Hospital	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical School	Nanjing	Jiangsu
China	Shenzhen Second People's Hospital	Shenzhen	Guangdong
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Institute of hematology&blood disease hospital	Tianjin	Tianjin
China	Institute of hematology&blood disease hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Henan Cancer Hospital	Zhengzhou	Henan
Czechia	Fakultní nemocnice Brno Bohunice	Brno	Brno-m?sto
Czechia	Fakultni nemocnice Hradec Kralove	Hradec Kralove
Czechia	Fakultni nemocnice Olomouc	Olomouc
Czechia	Fakultni nemocnice Ostrava	Ostrava-Poruba
Czechia	Fakultni Nemocnice Plzen	Plzen - Lochotin	Plzenský KRAJ
Czechia	Fakultni poliklinika	Praha	Praha 2
Czechia	Vseobecna fakultni nemocnice v Praze	Praha 2
Finland	Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)	Helsinki
Finland	Kuopion Yliopistollinen Sairaala	Kuopio	Pohjois-savo
Finland	Oulun yliopistollinen sairaala	Oulu	Pohjois-pohjanmaa
Finland	Tampereen yliopistollinen sairaala	Tampere
Finland	Tampereen yliopistollinen sairaala	Tampere	Pirkanmaa
Finland	Turku University Hospital	Turku	Varsinais-suomi
France	Hopital Claude Huriez - CHU de Lille	Lille	Nord
France	Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren	Limoges	Limousin
France	Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu	Nantes Cedex 1
France	Hopital Necker	Paris
France	Hôpital Saint Antoine	Paris Cedex 12
France	CHU Bordeaux Haut-Leveque	Pessac	Aquitaine
France	Centre Hospitalier Lyon Sud - Service d'Hematologie Clinique	Pierre Benite Cedex
France	CHU de Poitiers, Hôpital de la Milétrie, Pôle Régional de Cancérologie	Poitiers Cedex
France	Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE	Toulouse
Germany	Uniklinik RWTH Aachen	Aachen
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Staedtisches Klinikum Braunschweig gGmbH	Braunschweig
Germany	Klinikum Chemnitz gGMbH	Chemnitz
Germany	St. Barbara-Klinik Hamm-Heessen	Hamm
Germany	Universitaetsklinikum Koeln	Köln	Nordrhein-westfalen
Germany	Universitätsklinikum rechts der Isar, Technische Universität München (TUM)	Muenchen
Germany	Universitaetsklinikum Ulm	Ulm	Baden-württemberg
Germany	Universitätsklinikum Würzburg	Würzburg	Bayern
Greece	Alexandra General Hospital of Athens	Athens	Attikí
Greece	Evangelismos General Hospital of Athens	Athens	Attikí
Greece	University General Hospital of Ioannina	Ioannina
Greece	Theageneio Cancer Hospital of Thessaloniki	Thessaloniki	Kentrikí Makedonía
Italy	IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola	Bologna
Italy	Policlinico "G. Rodolico"	Catania	Sicilia
Italy	Ospedale San Martino	Genova	Liguria
Italy	IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"	Meldola	Emilia-romagna
Italy	ASST Santi Paolo e Carlo Ospedale San Carlo Borromeo SSD di Onco-Ematologia (Edificio C-piano terra)	Milano	Milan
Italy	Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico	Milano	Lombardia
Italy	Fondazione IRCCS San Gerardo dei Tintori	Monza	Lombardia
Italy	AOU Policlinico Umberto I	Roma
Italy	Fondazione Policlinico Universitario Agostino Gemelli	Roma
Italy	Azienda Ospedaliero Universitaria Senese	Siena	Toscana
Japan	Akita University Hospital	Akita
Japan	Kyushu University Hospital	Fukuoka
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	Hamamatsu University Hospital	Hamamatsu	Shizuoka
Japan	Kagoshima University Hospital	Kagoshima
Japan	National Hospital Organization Kumamoto Medical Center	Kumamoto
Japan	Nagasaki University Hospital	Nagasaki
Japan	Nagoya City University Hospital	Nagoya	Aichi
Japan	National Hospital Organization Okayama Medical Center	Okayama
Japan	Osaka Metropolitan University Hospital	Osaka
Japan	Tohoku University Hospital	Sendai	Miyagi
Japan	National Hospital Organization Shibukawa Medical Center	Shibukawa	Gunma
Japan	Japanese Red Cross Medical Center	Shibuya-ku	Tokyo
Japan	Shizuoka Cancer Center	Sunto-gun	Shizuoka
Japan	Tokushima University Hospital	Tokushima
Japan	Toyohashi Municipal Hospital	Toyohashi	Aichi
Japan	Iwate Medical University Hospital	Yahaba-cho, Shiwa-gun	Iwate
Japan	Yamagata University Hospital	Yamagata
Japan	University of Fukui Hospital	Yoshida-gun	Fukui
Korea, Republic of	Pusan National University Hospital	Busan	Pusan-kwangyokshi
Korea, Republic of	Kyungpook National University Hospital	Daegu	Taegu-kwangyokshi
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun-gun	Jeonranamdo
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Korea, Republic of	The Catholic Univ. of Korea Seoul St. Mary's Hospital	Seoul	Seoul-teukbyeolsi [seoul]
Mexico	Hematológica Alta Especialidad SC, consultorio 830	Colonia Valle De Las Palmas, Huixquilucan	México
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo LEÓN
Mexico	Centro de Investigacion Clinica de Oaxaca	Oaxaca
Mexico	Instituto Veracruzano en Investigación Clínica S.C.	Veracruz
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Erasmus Universitair Medisch Centrum	Rotterdam	Zuid-holland
New Zealand	Aotearoa Clinical Trials	Auckland
New Zealand	Labtests Auckland Ltd.	Auckland
New Zealand	North Shore Hospital	Auckland
New Zealand	Waikato District Health Board, Waikato Hospital	Hamilton
New Zealand	TRG Imaging	Milford, Auckland
New Zealand	Pacific Radiology	Newtown, Wellington
New Zealand	Broadway Radiology	Palmerston North
New Zealand	Palmerston North Hospital	Roslyn
New Zealand	Pharmacy on Shakespeare	Takapuna, Auckland
New Zealand	Capital, Coast and Hutt Valley District - Wellington Regional Hospital	Wellington
Norway	Haukeland Universitetssjukehus	Bergen	Hordaland
Norway	Oslo Universitetssykehus Ullevål	Oslo
Norway	Stavanger Universitetssykehus	Stavanger	Rogaland
Norway	St Olavs Hospital	Trondheim
Poland	Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy	Bydgoszcz
Poland	Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika Hematologii	Bydgoszcz
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk
Poland	Pratia Onkologia Katowice	Katowice
Poland	Uniwersytecki Szpital Kliniczny w Poznaniu	Poznan
Poland	Centrum Medyczne Pratia Poznan	Skorzewo
Poland	Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny	Warszawa
Poland	Klinika Hematologii, Nowotworow Krwi i Transplantacji Szpiku	Wroclaw
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Universitario Reina Sofía	Cordoba
Spain	Hospital Universitari De Girona Doctor Josep Trueta	Girona
Spain	Institut Català d'Oncologia - L'Hospitalet	L'Hospitalet Del Llobregat	Barcelona [barcelona]
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Madrid Sanchinarro	Madrid
Spain	Clinica Universidad de Navarra	Pamplona	Navarra
Spain	Hospital Universitario de Salamanca	Salamanca
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Complejo Hospitalario Universitario de Santiago	Santiago de Compostela	A Coruna
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Spain	Hospital Universitari Mutua Terrassa	Terrassa	Barcelona
Spain	Hospital Universitario de Toledo	Toledo	Other
Spain	Hospital Universitario y Politecnico La Fe	Valencia
Sweden	Södra Älvsborg Sjukhus	Borås
Sweden	Falu Lasarett	Falun
Sweden	Sahlgrenska Universitetssjukhuset	Göteborg
Sweden	Helsingborgs Lasarett	Helsingborg	Skåne LÄN [se-12]
Sweden	Universitetssjukhuset i Linköping	Linköping	Östergötlands LÄN [se-05]
Sweden	Sunderby Sjukhus	Luleå
Sweden	Skånes Universitetssjukhus Lund	Lund	Skåne LÄN [se-12]
Sweden	Universitetssjukhuset Örebro	Örebro	Örebro LÄN [se-18]
Taiwan	Chang Gung Memorial Hospital at Kaohsiung	Kaohsiung
Taiwan	China Medical University Hospital	Taichung
Taiwan	National Cheng Kung University Hospital	Tainan
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Turkey	Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi	Adana
Turkey	Ankara Universitesi Tip Fakultesi Hastanesi	Ankara
Turkey	Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi	Ankara
Turkey	Akdeniz Universitesi Hastanesi	Antalya
Turkey	Aydin Adnan Menderes Universitesi Hastanesi	Aydin
Turkey	Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi	Gaziantep
Turkey	Acibadem Universitesi Atakent Hastanesi	Istanbul	I?stanbul
Turkey	Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi	Istanbul	I?stanbul
Turkey	Medipol Mega Universite Hastanesi	Istanbul	I?stanbul
Turkey	Sisli Florence Nightingale Hastanesi	Istanbul / Sisli	I?stanbul
Turkey	Dokuz Eylul Universitesi Hastanesi	Izmir	I?zmir
Turkey	Ege Universitesi Hastanesi	Izmir	I?zmir
Turkey	Erciyes Universitesi Tip Fakultesi Hastaneleri	Kayseri
Turkey	Özel Anadolu Saglik Merkezi	Kocaeli
Turkey	Inonu Universitesi Turgut Ozal Tip Merkezi	Malatya
United Kingdom	Royal Bournemouth Hospital	Bournemouth	Dorset
United Kingdom	Bristol Haematology and Oncology Centre	Bristol
United Kingdom	Kent and Canterbury Hospital	Canterbury
United Kingdom	University Hospital of Wales	Cardiff	South Glamorgan
United Kingdom	The Christie NHS Foundation Trust	Manchester
United Kingdom	Churchill Hospital, Oxford University Hospitals NHS Foundation Trust	Oxford	Oxfordshire
United States	Sylvester Comprehensive Cancer Center - Aventura	Aventura	Florida
United States	MSK Basking Ridge	Basking Ridge	New Jersey
United States	Clovis Community Medical Center	Clovis	California
United States	Community Cancer Institute	Clovis	California
United States	MSK Commack	Commack	New York
United States	Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center	Coral Gables	Florida
United States	Sylvester Comprehensive Cancer Center - Coral Springs	Coral Springs	Florida
United States	Baylor University Medical Center	Dallas	Texas
United States	University of Miami Hospital and Clinics - Deerfield Beach	Deerfield Beach	Florida
United States	UCHealth Harmony	Fort Collins	Colorado
United States	UCHealth Poudre Valley Hospital	Fort Collins	Colorado
United States	Community Regional Medical Center	Fresno	California
United States	University of California San Francisco	Fresno	California
United States	UCHealth Greeley Hospital	Greeley	Colorado
United States	MSK Westchester	Harrison	New York
United States	Sylvester Comprehensive Cancer Center - Hollywood	Hollywood	Florida
United States	UCHealth - Medical Center of the Rockies	Loveland	Colorado
United States	Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Sylvester Comprehensive Cancer Center - Kendall	Miami	Florida
United States	University of Miami Hospital And Clinics	Miami	Florida
United States	MSK Monmouth	Middletown	New Jersey
United States	MSK Bergen	Montvale	New Jersey
United States	Tulane Cancer Center	New Orleans	Louisiana
United States	Tulane Medical Center	New Orleans	Louisiana
United States	Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).	New York	New York
United States	Memorial Sloan Kettering Cancer Center - Main Campus	New York	New York
United States	Sylvester Comprehensive Cancer Center - Plantation	Plantation	Florida
United States	Christus St. Vincent Regional Cancer Center	Santa Fe	New Mexico
United States	Christus St. Vincent Regional Medical Center	Santa Fe	New Mexico
United States	Santa Fe Imaging	Santa Fe	New Mexico
United States	MSK Nassau	Uniondale	New York

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  China,  Czechia,  Finland,  France,  Germany,  Greece,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Spain,  Sweden,  Taiwan,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part 1 Safety Lead-In: Incidence of dose limiting toxicities		First 42 days after first elranatamab dose
Primary	Part 2 Randomized: Progression free survival per International Myeloma Working Group criteria		From date of randomization to date of progressive disease, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months
Secondary	Part 1 Safety Lead-In: Progression free survival per International Myeloma Working Group criteria		From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Secondary	Overall survival		From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Secondary	Objective response rate per International Myeloma Working Group criteria		From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
Secondary	Duration of response per International Myeloma Working Group criteria		From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Secondary	Time to response per International Myeloma Working Group criteria		From date of randomization to date of confirmed objective response, assessed up to 51 months
Secondary	Complete response rate per International Myeloma Working Group criteria		From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
Secondary	Duration of complete response per International Myeloma Working Group criteria		From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first, assessed up to 51 months
Secondary	Minimal residual disease negativity rate per International Myeloma Working Group criteria		From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
Secondary	Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria		From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first, assessed up to 51 months
Secondary	Progression free survival on next-line treatment per International Myeloma Working Group criteria		From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first, assessed up to 51 months
Secondary	Frequency of treatment-emergent adverse events		From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.
Secondary	Frequency of abnormal laboratory results		From date of first dose of study intervention through minimum of 90 days after last study intervention administration. Reporting of non-serious AEs ends at start of new anti-cancer therapy.
Secondary	Rate of Grade =2 cytokine release syndrome		First 28 days after first elranatamab dose
Secondary	Elranatamab pharmacokinetics by pre- and post-dose concentrations		From date of first dose through up to 14 days after date of last dose of elranatamab
Secondary	Elranatamab immunogenicity by anti-drug antibodies against elranatamab		From date of first dose through up to 14 days after date of last dose of elranatamab
Secondary	Daratumumab pharmacokinetics by pre-dose concentrations		From date of first dose through up to 14 days after date of last dose of daratumumab
Secondary	Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30		From date of informed consent through up to 35 days after date of last dose of study intervention
Secondary	Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20		From date of informed consent through up to 35 days after date of last dose of study intervention

External Links

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