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

Last updated: June 22, 2026
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Platelet Disorders

Lymphoproliferative Disorders

Bone Diseases

Treatment

Bortezomib

Dexamethasone

Lenalidomide

Clinical Study ID

NCT05623020
C1071006
MAGNETISMM-6
2021-000803-20
2024-514139-50-00
  • Ages > 18
  • All Genders

Study 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

Inclusion

Inclusion Criteria:

  • Diagnosis of multiple myeloma (MM) as defined by IMWG criteria (Rajkumar et al.,
  • Measurable disease based on IMWG criteria as defined by at least 1 of the following:

  • Serum M-protein ≥0.5 g/dL (Part 1) and ≥1 g/dL (Part 2);

  • Urinary M-protein excretion ≥200 mg/24 hours;

  • Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa tolambda FLC ratio (<0.26 or >1.65).

  • Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who havereceived 1-2 prior lines of therapy including at least one immunomodulatory drug andone proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years ortransplant-ineligible as defined by age <65 years with comorbidities impacting thepossibility of transplant.

  • Part 2: participants with newly-diagnosed multiple myeloma that aretransplant-ineligible defined as:

  • Participants not considered candidates for high-dose chemotherapy and ASCT dueto age or

  • Participants with important comorbidities likely to have a negative impact ontolerability of high dose chemotherapy and ASCT.

  • ECOG performance status ≤2.

  • Not pregnant and willing to use contraception

  • For participants with RRMM: Resolved acute effects of any prior therapy to baselineseverity or CTCAE Grade ≤1.

Exclusion

Exclusion Criteria:

  • Smoldering Multiple Myeloma.

  • Monoclonal gammopathy of undetermined significance.

  • Waldenströms Macroglobulinemia

  • Plasma cell leukemia.

  • Active, uncontrolled bacterial, fungal, or viral infection, including (but notlimited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.

  • Any other active malignancy within 3 years prior to enrollment, except foradequately treated basal cell or squamous cell skin cancer, carcinoma in situ, orStage 0/1 with minimal risk of recurrence per investigator.

  • For participants with RRMM: Previous treatment with a BCMA-directed therapy oranti-CD38-directed therapy within 6 months preceding the first dose of studyintervention in this study. Stem cell transplant ≤3 months prior to first dose ofstudy intervention or active GVHD.

  • For participants with NDMM: Previous systemic treatment for MM except for a shortcourse of corticosteroids (ie, total of 160 mg dexamethasone or equivalent beforethe first dose of study intervention). A cumulative dose of systemic corticosteroidsequivalent to ≥20 mg of dexamethasone during screening.

  • Live attenuated vaccine administered within 4 weeks of the first dose of studyintervention.

  • Administration of investigational product (eg, drug or vaccine) concurrent withstudy intervention or within 30 days (or as determined by the local requirement)preceding the first dose of study intervention used in this study.

Study Design

Total Participants: 1116
Treatment Group(s): 5
Primary Treatment: Bortezomib
Phase: 3
Study Start date:
November 10, 2022
Estimated Completion Date:
October 03, 2033

Connect with a study center

  • Pindara Private Hospital

    Benowa, Queensland 4217
    Australia

    Active - Recruiting

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Epworth Freemasons

    Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Epworth Healthcare

    Richmond, Victoria 3121
    Australia

    Active - Recruiting

  • Epworth Hospital

    Richmond, Victoria 3121
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne 2158177, Victoria 2145234 3004
    Australia

    Active - Recruiting

  • Medizinische Universität Graz

    Graz, Styria 8036
    Austria

    Site Not Available

  • Uniklinikum Salzburg

    Salzburg, 5020
    Austria

    Site Not Available

  • Medizinische Universität Wien

    Vienna, 1090
    Austria

    Site Not Available

  • Grand Hôpital de Charleroi

    Gilly, Hainaut 6060
    Belgium

    Site Not Available

  • AZ Delta vzw

    Roeselare, West-vlaanderen 8800
    Belgium

    Active - Recruiting

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • Dr. Everett Chalmers Regional Hospital

    Fredericton, New Brunswick E3B 5N5
    Canada

    Site Not Available

  • Nova Scotia Health Authority

    Halifax, Nova Scotia B3S 0H6
    Canada

    Active - Recruiting

  • QEII Health Sciences Centre

    Halifax, Nova Scotia B3H 2Y9
    Canada

    Active - Recruiting

  • QEII Health Sciences Centre

    Halifax 6324729, Nova Scotia 6091530 B3H 2Y9
    Canada

    Active - Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality 100091
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350001
    China

    Active - Recruiting

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510555
    China

    Active - Recruiting

  • Southern Medical University Nanfang Hospital

    Guangzhou 1809858, Guangdong 1809935 510515
    China

    Site Not Available

  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210008
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • The first hospital of jilin university

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • Tongji University - Shanghai Fourth People's Hospital

    Shanghai, Shanghai Municipality 200434
    China

    Active - Recruiting

  • Institute of hematology&blood disease hospital

    Tianjin, Tianjin Municipality 300020
    China

    Active - Recruiting

  • The first Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • The first Affiliated hospital of Wenzhou medical University

    Wenzhou, Zhejiang 325000
    China

    Active - Recruiting

  • The first hospital of jilin university

    Changchun 2038180, 130021
    China

    Site Not Available

  • Fakultní nemocnice Brno Bohunice

    Brno, Brno-město 625 00
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Ostrava

    Ostrava, Moravskoslezský KRAJ 708 52
    Czechia

    Active - Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00
    Czechia

    Active - Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808
    Czechia

    Active - Recruiting

  • Kuopion Yliopistollinen Sairaala

    Kuopio, Northern Savonia 70210
    Finland

    Active - Recruiting

  • Turku University Hospital

    Turku, Southwest Finland 20520
    Finland

    Active - Recruiting

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

    Helsinki, 00029
    Finland

    Active - Recruiting

  • Oulu University Hospital

    Oulu, 90220
    Finland

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

    Nice, Alpes-maritimes 06200
    France

    Site Not Available

  • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

    Toulouse, Haute-garonne 31100
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne 86021
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

    Nantes, 44093 Cedex 1
    France

    Active - Recruiting

  • Hôpital Saint Antoine

    Paris, 75012
    France

    Site Not Available

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg 72076
    Germany

    Active - Recruiting

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg 89081
    Germany

    Site Not Available

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate 55131
    Germany

    Active - Recruiting

  • Städtisches Klinikum Braunschweig

    Braunschweig, 38114
    Germany

    Site Not Available

  • Klinikum Chemnitz

    Chemnitz, 09116
    Germany

    Active - Recruiting

  • Alexandra General Hospital of Athens

    Athens, Attikí 115 28
    Greece

    Active - Recruiting

  • Evangelismos General Hospital of Athens

    Athens, Attikí 106 76
    Greece

    Active - Recruiting

  • Evangelismos General Hospital of Athens

    Athens 264371, Attikí 106 76
    Greece

    Active - Recruiting

  • "Theagenio" Cancer Hospital of Thessaloniki

    Thessaloniki, Kentrikí Makedonía 540 07
    Greece

    Active - Recruiting

  • University Hospital of Ioannina

    Ioannina, Ípeiros 455 00
    Greece

    Active - Recruiting

  • Rabin Medical Center

    Petah Tikva, Central District 4910021
    Israel

    Active - Recruiting

  • The Edmond and Lily Safra Children's Hospital; The Chaim Sheba Medical Center

    Ramat Gan, Central District 5265601
    Israel

    Active - Recruiting

  • The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric

    Ramat Gan, Central District 294904 5265601
    Israel

    Site Not Available

  • The Edmond and Lily Safra Children's HospitalnThe Chaim Sheba Medical CenternDepartment of Pediatric

    Ramat Gan, Central District 294904 5265601
    Israel

    Site Not Available

  • Hadassah Medical Center

    Jerusalem, Jerusalem 9112001
    Israel

    Active - Recruiting

  • Soroka Medical Center

    Beersheba, Southern District 8410101
    Israel

    Active - Recruiting

  • Sourasky Medical Center

    Tel Aviv, TELL ABĪB 6423906
    Israel

    Active - Recruiting

  • IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l

    Meldola (Fc), Emilia-Romagna 47014
    Italy

    Active - Recruiting

  • AUSL di Piacenza

    Piacenza, Emilia-Romagna 29121
    Italy

    Active - Recruiting

  • Ospedale Santa Maria delle Croci

    Ravenna, Emilia-Romagna 48121
    Italy

    Active - Recruiting

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo, FG 71013
    Italy

    Active - Recruiting

  • Cro-Irccs

    Aviano, Friuli Venezia Giulia 33081
    Italy

    Active - Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Lombardy 20900
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

    Turin, Piedmont 10126
    Italy

    Active - Recruiting

  • A.O.U. Policlinico Paolo Giaccone

    Palermo, Sicily 90127
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany 56126
    Italy

    Active - Recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127
    Italy

    Active - Recruiting

  • Istituto Europeo di Oncologia IRCCS

    Milan, 20141
    Italy

    Active - Recruiting

  • ASL PESCARA-Presidio Ospedaliero Pescara

    Pescara, 65124
    Italy

    Active - Recruiting

  • Azienda Sanitaria Locale di Pescara

    Pescara, 65124
    Italy

    Active - Recruiting

  • ASL PESCARA-Presidio Ospedaliero Pescara

    Pescara 3171168, 65124
    Italy

    Active - Recruiting

  • AOU Policlinico Umberto I

    Roma, 00161
    Italy

    Active - Recruiting

  • University of Fukui Hospital

    Yoshida-gun, Fukui 910-1193
    Japan

    Active - Recruiting

  • Gunma University Hospital

    Maebashi, Gunma 371-8511
    Japan

    Active - Recruiting

  • Iwate Medical University Hospital

    Yahaba-cho, Iwate 028-3695
    Japan

    Active - Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi 980-8574
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho,Sunto-gun, Shizuoka 411-8777
    Japan

    Active - Recruiting

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo 150-8935
    Japan

    Active - Recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-0051
    Japan

    Active - Recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585
    Japan

    Active - Recruiting

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon-gwangyeoksi [incheon] 21565
    Korea, Republic of

    Active - Recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeonranamdo 58128
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do 13620
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 03080
    Korea, Republic of

    Active - Recruiting

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk

    Dordrecht, South Holland 3318 AT
    Netherlands

    Active - Recruiting

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

    Wroclaw, Lower Silesian Voivodeship 50-367
    Poland

    Site Not Available

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship 80-214
    Poland

    Active - Recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdańsk, Pomorskie 80-214
    Poland

    Active - Recruiting

  • Pratia Onkologia Katowice

    Katowice, Silesian Voivodeship 40-519
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Poznań

    Skorzewo, Wielkopolskie 60-185
    Poland

    Active - Recruiting

  • Auxilio Mutuo Cancer Center

    San Juan, 00917
    Puerto Rico

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeonranamdo 58128
    South Korea

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do 13620
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul] 06351
    South Korea

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 03080
    South Korea

    Active - Recruiting

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul, Seoul-teukbyeolsi [seoul] 06591
    South Korea

    Active - Recruiting

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)

    Seoul, Seoul-teukbyeolsi [seoul] 06591
    South Korea

    Active - Recruiting

  • Samsung Medical Center

    Seoul 1835848, Seoul-teukbyeolsi [seoul] 06351
    South Korea

    Site Not Available

  • Seoul National University Hospital

    Seoul 1835848, Seoul-teukbyeolsi [seoul] 03080
    South Korea

    Active - Recruiting

  • The Catholic Univ. of Korea Seoul St. Mary's Hospital

    Seoul 1835848, Seoul-teukbyeolsi [seoul] 06591
    South Korea

    Site Not Available

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, A Coruña [LA Coruña] 15706
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia (ICO) - Badalona

    Badalona, Barcelona [barcelona] 08916
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia - L'Hospitalet

    L'Hospitalet Del Llobregat, Barcelona [barcelona] 08908
    Spain

    Active - Recruiting

  • Hospital Universitari Mutua Terrassa

    Terrassa, Barcelona [barcelona] 08221
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria 39008
    Spain

    Site Not Available

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [cataluña] 08036
    Spain

    Active - Recruiting

  • Institut Català d'Oncologia (ICO) - Girona

    Girona, Girona [gerona] 17007
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Madrid, Madrid, Comunidad de 28027
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Madrid 3117735, Madrid, Comunidad de 28027
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarre 31008
    Spain

    Active - Recruiting

  • Hospital Universitario Doctor Peset

    Valencia, València 46017
    Spain

    Active - Recruiting

  • Hospital San Pedro de Alcántara

    Cáceres, 10003
    Spain

    Active - Recruiting

  • Hospital La Princesa

    Madrid, 28006
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid 3117735, 28040
    Spain

    Active - Recruiting

  • H.R.U Málaga - Hospital General

    Málaga, 29010
    Spain

    Active - Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • Kantonsspital Winterthur

    Winterthur, 8401
    Switzerland

    Site Not Available

  • China Medical University Hospital

    Taichung, 404332
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    Taichung 1668399, 404332
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Leicester Royal Infirmary

    Leicester, England LE1 5WW
    United Kingdom

    Active - Recruiting

  • Jupiter Medical Center/Anderson Family Cancer Institute

    Jupiter, Florida 33458
    United States

    Site Not Available

  • MSK Basking Ridge

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • MSK Monmouth

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • MSK Bergen

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • MSK Commack

    Commack, New York 11725
    United States

    Active - Recruiting

  • MSK Westchester

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).

    New York, New York 10021
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center - Main Campus

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center-Main Campus

    New York, New York 10065
    United States

    Active - Recruiting

  • MSK Nassau

    Uniondale, New York 11553
    United States

    Active - Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Active - Recruiting

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