A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
Start Date
11/10/2022
Completion Date
10/3/2033
Summary
Elranatamab is a bispecific antibody: binding of elranatamab to CD3-expressing T-cells and BCMA-expressing multiple myeloma cells causes targeted T-cell-mediated cytotoxicity. The main purpose of the study is to evaluate if the combination of Elranatamab, Daratumumab and Lenalidomide offers superior clinical benefit compared with the combination of Daratumumab, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma. There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with lenalidomide and will identify the optimal dose(s) of the combination regimen. Part 2 of the study will evaluate the rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Elranatamab
Daratumumab
Lenalidomide
Dexamethasone
Bortezomib
Conditions
Locations
Jupiter Medical Center/Anderson Family Cancer Institute
Jupiter, Florida 33458
United States
MSK Basking Ridge
Basking Ridge, New Jersey 07920
United States
MSK Monmouth
Middletown, New Jersey 07748
United States
MSK Bergen
Montvale, New Jersey 07645
United States
MSK Commack
Commack, New York 11725
United States
MSK Westchester
Harrison, New York 10604
United States
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York 10021
United States
Memorial Sloan Kettering Cancer Center-Main Campus
New York, New York 10065
United States
MSK Nassau
Uniondale, New York 11553
United States
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
United States
Pindara Private Hospital
Benowa, Queensland 4217
Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
Australia
Epworth Freemasons
Melbourne, Victoria 3002
Australia
The Alfred Hospital
Melbourne, Victoria 3004
Australia
Epworth Healthcare
Richmond, Victoria 3121
Australia
Medizinische Universität Graz
Graz, Styria 8036
Austria
Landeskrankenhaus Feldkirch
Rankweil, Vorarlberg 6830
Austria
Uniklinikum Salzburg
Salzburg, 5020
Austria
Medizinische Universität Wien
Vienna, 1090
Austria
Clinique Saint Pierre
Ottignies, Brabant Wallon 1340
Belgium
Grand Hôpital de Charleroi
Gilly, Hainaut 6060
Belgium
AZ Delta vzw
Roeselare, West-vlaanderen 8800
Belgium
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP)
Ribeirão Preto, São Paulo 14051-140
Brazil
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Canada
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick E3B 5N5
Canada
QEII Health Sciences Centre
Halifax, Nova Scotia B3H 2Y9
Canada
Nova Scotia Health Authority
Halifax, Nova Scotia B3S 0H6
Canada
Princess Margaret Cancer Centre
Toronto, Ontario M5G 2M9
Canada
Peking University Third Hospital
Beijing, Beijing Municipality 100091
China
Fujian Medical University Union Hospital
Fuzhou, Fujian 350001
China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong 510515
China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510555
China
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei 430030
China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu 210008
China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
China
The first hospital of jilin university
Changchun, Jilin 130021
China
Tongji University - Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality 200434
China
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality 300020
China
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
China
The first Affiliated hospital of Wenzhou medical University
Wenzhou, Zhejiang 325000
China
Fakultní nemocnice Brno Bohunice
Brno, Brno-město 625 00
Czechia
Fakultni nemocnice Olomouc
Olomouc, 779 00
Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 12808
Czechia
Kuopion Yliopistollinen Sairaala
Kuopio, Northern Savonia 70210
Finland
Turku University Hospital
Turku, Southwest Finland 20520
Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, 00029
Finland
Oulu University Hospital
Oulu, 90220
Finland
Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
Nice, Alpes-maritimes 06200
France
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
Toulouse, Haute-garonne 31100
France
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne 86021
France
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
Nantes, 44093 Cedex 1
France
Hôpital Saint Antoine
Paris, 75012
France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg 72076
Germany
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg 89081
Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate 55131
Germany
Städtisches Klinikum Braunschweig
Braunschweig, 38114
Germany
Klinikum Chemnitz
Chemnitz, 09116
Germany
Evangelismos General Hospital of Athens
Athens, Attikí 106 76
Greece
Alexandra General Hospital of Athens
Athens, Attikí 115 28
Greece
"Theagenio" Cancer Hospital of Thessaloniki
Thessaloniki, Kentrikí Makedonía 540 07
Greece
Evangelismos General Hospital of Athens
Athens, 10676
Greece
University Hospital of Ioannina
Ioannina, Ípeiros 455 00
Greece
Rabin Medical Center
Petah Tikva, Central District 4910021
Israel
The Edmond and Lily Safra Children's Hospital; The Chaim Sheba Medical Center
Ramat Gan, Central District 5265601
Israel
Hadassah Medical Center
Jerusalem, Jerusalem 9112001
Israel
Soroka Medical Center
Beersheba, Southern District 8410101
Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB 6423906
Israel
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l
Meldola (Fc), Emilia-Romagna 47014
Italy
AUSL di Piacenza
Piacenza, Emilia-Romagna 29121
Italy
Ospedale Santa Maria delle Croci
Ravenna, Emilia-Romagna 48121
Italy
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG 71013
Italy
Cro-Irccs
Aviano, Friuli Venezia Giulia 33081
Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy 20900
Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont 10126
Italy
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily 90127
Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany 56126
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, 24127
Italy
Istituto Europeo di Oncologia IRCCS
Milan, 20141
Italy
ASL PESCARA-Presidio Ospedaliero Pescara
Pescara, 65124
Italy
Azienda Sanitaria Locale di Pescara
Pescara, 65124
Italy
AOU Policlinico Umberto I
Roma, 00161
Italy
University of Fukui Hospital
Yoshida-gun, Fukui 910-1193
Japan
Gunma University Hospital
Maebashi, Gunma 371-8511
Japan
Iwate Medical University Hospital
Yahaba-cho, Iwate 028-3695
Japan
Tohoku University Hospital
Sendai, Miyagi 980-8574
Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka 411-8777
Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo 150-8935
Japan
Kyushu University Hospital
Fukuoka, 812-8582
Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192
Japan
Osaka Metropolitan University Hospital
Osaka, 545-0051
Japan
Yamagata University Hospital
Yamagata, 990-9585
Japan
Albert Schweitzer Ziekenhuis, locatie Dordwijk
Dordrecht, South Holland 3318 AT
Netherlands
Auckland City Hospital
Grafton, Auckland 1023
New Zealand
Waikato Hospital
Hamilton, Waikato Region 3204
New Zealand
North Shore Hospital
Auckland, 0622
New Zealand
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship 50-367
Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship 80-214
Poland
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship 40-519
Poland
Auxilio Mutuo Cancer Center
San Juan, 00917
Puerto Rico
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeonranamdo 58128
South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do 13620
South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul] 03080
South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul] 06351
South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)
Seoul, Seoul-teukbyeolsi [seoul] 06591
South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul] 06591
South Korea
CHUS - Hospital Clinico Universitario
Santiago de Compostela, A Coruña [LA Coruña] 15706
Spain
Institut Català d'Oncologia (ICO) - Badalona
Badalona, Barcelona [barcelona] 08916
Spain
Institut Català d'Oncologia - L'Hospitalet
L'Hospitalet Del Llobregat, Barcelona [barcelona] 08908
Spain
Hospital Universitari Mutua Terrassa
Terrassa, Barcelona [barcelona] 08221
Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria 39008
Spain
Hospital Clínic de Barcelona
Barcelona, Catalunya [cataluña] 08036
Spain
Institut Català d'Oncologia (ICO) - Girona
Girona, Girona [gerona] 17007
Spain
Clinica Universidad de Navarra
Madrid, Madrid, Comunidad de 28027
Spain
Clinica Universidad de Navarra
Pamplona, Navarre 31008
Spain
Hospital Universitario Doctor Peset
Valencia, València 46017
Spain
Hospital San Pedro de Alcántara
Cáceres, 10003
Spain
Hospital La Princesa
Madrid, 28006
Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Spain
H.R.U Málaga - Hospital General
Málaga, 29010
Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026
Spain
Kantonsspital Winterthur
Winterthur, 8401
Switzerland
China Medical University Hospital
Taichung, 404332
Taiwan
Taichung Veterans General Hospital
Taichung, 407
Taiwan
National Taiwan University Hospital
Taipei, 10002
Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan, 333
Taiwan
Leicester Royal Infirmary
Leicester, England LE1 5WW
United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW
United Kingdom