AzTrials
AzTrials

Multiple MyelomaPhase 3MagnetisMM-7NCT05317416

Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

A Phase 3 study testing Elranatamab and Lenalidomide in people with Multiple Myeloma, run by Pfizer at 209 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma
What is being tested?
Elranatamab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
854 participants
Where
209 sitesin 27 countries
Study dates
25 Mar 2022to 31 Oct 2029
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis
  • Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive
  • History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT.
  • Partial Response or better according to IMWG criteria at the time of randomization
  • Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant.
  • ECOG performance status ≤1
  • Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1
  • Not pregnant and willing to use contraception

Who cannot join

  • Plasma cell leukemia
  • Amyloidosis, Waldenström's macroglobulinemia
  • POEMS syndrome
  • Known active CNS involvement or clinical signs of myelomatous meningeal involvement
  • Previous MM maintenance treatment
  • Prior treatment with BCMA targeted therapy
Show all 9Show fewer
  • Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
  • Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness
  • Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Trial locations and contacts

209 sites in 27 countries.

209 sites in 27 countries

United States24 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • OhioHealth Arthur G.H. Bing, MD, Cancer Center

    Columbus, Ohio, 43214

  • OhioHealth Research Institute

    Columbus, Ohio, 43214

  • OhioHealth Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Baylor University Medical Center

    Dallas, Texas, 75246

  • Banner Gateway Medical Center

    Gilbert, Arizona, 85234

  • Banner Gateway Medical Pavilion

    Gilbert, Arizona, 85234

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • WMCHealth Advanced Physician Services

    Hawthorne, New York, 10532

  • American Oncology Partners, P.A. Dba MidAmerica Cancer Care

    Kansas City, Missouri, 64132

  • Ascentist Doctor Hospital

    Leawood, Kansas, 66211

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • UCLA Department of Medicine - Hematology/Oncology

    Los Angeles, California, 90095

  • UCLA Hematology/Oncology

    Los Angeles, California, 90095

  • Loyola University Chicago

    Maywood, Illinois, 60153

  • Miami Cancer Institute at Baptist Health, Inc.

    Miami, Florida, 33176

  • Santa Monica UCLA Medical Center & Orthopaedic Hospital

    Santa Monica, California, 90404

  • UCLA Hematology/Oncology - Santa Monica

    Santa Monica, California, 90404

  • Baylor Scott & White Medical Center - Temple

    Temple, Texas, 76508

  • Westchester Medical Center

    Valhalla, New York, 10595

  • Georgetown University Medical Center

    Washington D.C., District of Columbia, 20007

Other trials in United States

Spain18 sites

  • Institut Catala d' Oncologia. Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital Universitari Vall d'Hebron

    Barcelona, Barcelona [barcelona], 08035

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [cataluña], 08036

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

  • Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta

    Girona, 17007

  • Institut Català d'Oncologia - L'Hospitalet

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

  • Clinica Universidad de Navarra

    Madrid, Madrid, Comunidad de, 28027

  • Hospital Universitario La Paz

    Madrid, Madrid, Comunidad de, 28046

  • Hospital La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario de Salamanca

    Salamanca, Castille and León, 37007

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007

  • Complejo Hospitalario Universitario de Santiago

    Santiago de Compostela, A Coruna, 15706

  • Hospital Universitari Mutua Terrassa

    Terrassa, Barcelona [barcelona], 08221

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Brazil15 sites

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-080

  • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

    Porto Alegre, Rio Grande do Sul, 90110-270

  • Centro de Pesquisa Clínica - Área Administrativa

    Porto Alegre, Rio Grande do Sul, 90850-170

  • Hospital Mae de Deus

    Porto Alegre, Rio Grande do Sul, 90880-480

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP)

    Ribeirão Preto, São Paulo, 14051-140

  • Américas Medical City

    Rio de Janeiro, 22775-001

  • Instituto de Educação, Pesquisa e Gestão em Saúde

    Rio de Janeiro, 22775001

  • Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador

    Salvador, Estado de Bahia, 41253-190

  • BP - A Beneficencia Portuguesa de São Paulo

    São Paulo, São Paulo, 01321-001

  • ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis

    São Paulo, 01232-010

  • HU UNIFESP / SPDM - Hospital São Paulo

    São Paulo, 04024-002

  • Universidade Federal de Sao Paulo

    São Paulo, 04024-002

  • Hospital Japonês Santa Cruz

    São Paulo, 04122-000

  • Clínica Médica São Germano S/S Ltda

    São Paulo, 04537-080

  • Clínica Médica São Germano LTDA

    SP, São Paulo, 04537-080

Other trials in Brazil

Japan15 sites

  • Nippon Medical School Hospital

    Bunkyo-ku, Tokyo, 113-8603

  • Hamamatsu University Hospital

    Hamamatsu, Shizuoka, 431-3192

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • National Hospital Organization Kumamoto Medical Center

    Kumamoto, 860-0008

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, Kyoto, 602-8566

  • University Hospital,Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777

  • Japanese Red Cross Medical Center

    Tokyo, 150-8935

  • Iwate Medical University Hospital

    Yahaba-cho, Iwate, 028-3695

  • Yamagata University Hospital

    Yamagata, Yamagata, 990-9585

Other trials in Japan

Australia11 sites

  • Pindara Private Hospital

    Benowa, Queensland, 4217

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • QScan Radiology Clinics

    Clayfield, Queensland, 4011

  • Epworth Healthcare

    East Melbourne, Victoria, 3002

  • Precision Haematology

    East Melbourne, Victoria, 3002

  • St Vincent's Hospital (Melbourne)

    Fitzroy, Victoria, 3065

  • Shoalhaven District Memorial Hospital

    Nowra, New South Wales, 2541

  • Slade Pharmacy

    Richmond, 3121

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Canada9 sites

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

  • Dr. Everett Chalmers Regional Hospital

    Fredericton, New Brunswick, E3B 5N5

  • Hamilton Health Sciences Corporation

    Hamilton, Ontario, L8L 8E7

  • Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,

    Montreal, Quebec, H1T 2M4

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎ

    Montreal, Quebec, H4J 1C5

  • Saint John Regional Hospital

    Saint John, New Brunswick, E2L 4L2

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

  • Windsor Regional Hospital Cancer Program

    Windsor, Ontario, N8W 1L9

Other trials in Canada

South Korea9 sites

  • Pusan National University Hospital

    Busan, Pusan-kwangyǒkshi, 49241

  • Kyungpook National University

    Daegu, Taegu-kwangyǒkshi, 41944

  • Chonnam National University Hwasun Hospital

    Hwasun Gun, Jeonranamdo, 58128

  • Kyungpook National University Hospital

    Junggu, Taegu-kwangyǒkshi, 41944

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon-gwangyeoksi [incheon], 21565

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03080

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 06351

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

    Seoul, Seoul-teukbyeolsi [seoul], 06591

Other trials in South Korea

Turkey (Türkiye)9 sites

  • Ankara University Health Practice and Research Hospitals

    Ankara, 06100

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

    Ankara, 06200

  • Aydın Adnan Menderes Universitesi Hastanesi

    Aydin, 09100

  • Medipol Mega Universite Hastanesi

    Istanbul, İ̇stanbul, 34214

  • Sisli Florence Nightingale Hastanesi

    Istanbul, İ̇stanbul, 34381

  • Ege Universitesi Hastanesi

    Izmir, İ̇zmir, 35100

  • Dokuz Eylul Universitesi Hastanesi

    Izmir, İ̇zmir, 35340

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri

    Kayseri, 38030

  • Özel Anadolu Sağlık Merkezi

    Kocaeli, 41400

Other trials in Turkey (Türkiye)

France8 sites

  • Hopital Claude Huriez - CHU de Lille

    Lille, 59037

  • Pitie Salpetriere University Hospital

    Paris, ORNE, 75013

  • Hôpital Saint Antoine

    Paris, 75571

  • Hopital Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne, 86021

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

    Toulouse, Haute-garonne, 31100

  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

    Tours, 37032

  • Gustave Roussy

    Villejuif, Val-de-marne, 94800

Other trials in France

Germany8 sites

  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin

    Berlin, 12200

  • Klinikum Chemnitz gGMbH

    Chemnitz, 09116

  • Universitätsklinikum Essen

    Essen, 45147

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

Israel8 sites

  • Soroka Medical Center

    Beersheba, Southern District, 8410101

  • Rambam Health Care Campus

    Haifa, Northern District, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9013102

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001

  • Hadassah Mount Scopus Medical Center

    Jerusalem, Jerusalem, 9124001

  • Rabin Medical Center

    Petah Tikva, Central District, 4910021

  • Sheba Medical Center

    Ramat Gan, Central District, 5262100

  • Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital

    Tel Aviv, TELL ABĪB, 6423906

Other trials in Israel

Italy8 sites

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi

    Ancona, 60126

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, 40138

  • Policlinico "G. Rodolico"

    Catania, Sicily, 95123

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"

    Meldola, Emilia-Romagna, 47014

  • Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

  • AOU Policlinico Umberto I

    Roma, 00161

  • Fondazione Policlinico Universitario Agostino Gemelli

    Rome, Lazio, 00168

  • Azienda Ospedaliero Universitaria Senese

    Siena, Tuscany, 53100

Other trials in Italy

Belgium7 sites

  • Institut Jules Bordet

    Anderlecht, Bruxelles-capitale, Région de, 1070

  • ZNA Middelheim

    Antwerp, 2020

  • ZNA Cadix

    Antwerp, 2030

  • UZ Brussel

    Brussels, 1090

  • Grand Hôpital de Charleroi

    Charleroi, Hainaut, 6060

  • UZ Gent

    Ghent, Oost-vlaanderen, 9000

  • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi

    Yvoir, Namur, 5530

Other trials in Belgium

Poland7 sites

  • Uniwersyteckie Centrum Kliniczne,

    Gdansk, 80-214

  • Pratia Onkologia Katowice

    Katowice, Silesian Voivodeship, 40-519

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan, 60-569

  • Centrum Medyczne Pratia Poznań

    Skórzewo, Greater Poland Voivodeship, 60-185

  • Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny

    Warsaw, 02-097

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy

    Warsaw, 02-781

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

    Wroclaw, 50-367

Other trials in Poland

India6 sites

  • Himalayan Institute Hospital Trust University

    Dehradun, Uttarakhand, 248140

  • Rajiv Gandhi Cancer Institute And Research Centre

    Delhi, 110085

  • Artemis hospital

    Gurugram, Haryana, 122001

  • Medanta-The Medicity

    Gurugram, Haryana, 122001

  • Fortis Memorial Research Institute

    Gurugram, Haryana, 122002

  • Tata Medical Center

    Kolkata, West Bengal, 700160

Other trials in India

Sweden6 sites

  • Södra Älvsborgs Sjukhus Borås

    Borås, Västra Götalands LÄN [se-14], 501 82

  • Falu Lasarett

    Falun, 791 31

  • Helsingborgs Lasarett

    Helsingborg, Skåne LÄN [se-12], 251 87

  • Universitetssjukhuset i Linköping

    Linköping, Östergötlands LÄN [se-05], 581 85

  • Universitetssjukhuset Örebro

    Örebro, Örebro LÄN [se-18], 701 85

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, Stockholms LÄN [se-01], 141 86

Other trials in Sweden

United Kingdom6 sites

  • Belfast City Hospital

    Belfast, BT9 7AB

  • Queen Elizabeth Hospital Birmingham

    Birmingham, England, B15 2TH

  • Addenbrooke's Hospital

    Cambridge, Cambridgeshire, CB2 2QQ

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

  • Royal Berkshire Hospital

    Reading, RG1 5AN

  • New Cross Hospital

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Czechia5 sites

  • Fakultní nemocnice Brno Bohunice

    Brno, Brno-město, 625 00

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, Hradec Králové, 500 05

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

  • Fakultni nemocnice Ostrava

    Ostrava, Moravian-Silesian Region, 708 52

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

Other trials in Czechia

Hungary5 sites

  • Semmelweis University

    Budapest, 1088

  • Dél-Pesti Centrumkórház

    Budapest, 1097

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, Somogy County, 7400

  • Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház

    Nyíregyháza, 4400

Other trials in Hungary

Switzerland5 sites

  • Kantonsspital Baden

    Baden, 5404

  • Inselspital Bern

    Bern, Canton of Bern, 3010

  • CHUV (centre hospitalier universitaire vaudois)

    Lausanne, Canton of Vaud, 1011

  • Kantonsspital Winterthur

    Winterthur, 8401

  • UniversitätsSpital Zürich

    Zurich, Zürich (DE), 8091

Other trials in Switzerland

Taiwan5 sites

  • China Medical University Hospital

    Taichung, 40447

  • Taichung Veterans General Hospital

    Taichung, 407

  • National Taiwan University Hospital

    Taipei, 10002

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

Other trials in Taiwan

China3 sites

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510555

  • Institute of hematology&blood disease hospital

    Tianjin, Tianjin Municipality, 300020

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000

Other trials in China

Finland3 sites

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

    Helsinki, Uusimaa, 00029

  • Oulun yliopistollinen sairaala

    Oulu, 90220

  • Turku University Hospital

    Turku, Southwest Finland, 20520

Other trials in Finland

Greece3 sites

  • Alexandra General Hospital of Athens

    Athens, Attikí, 115 28

  • University Hospital of Ioannina

    Ioannina, Ípeiros, 455 00

  • Theageneio Cancer Hospital of Thessaloniki

    Thessaloniki, Kentrikí Makedonía, 546 39

Other trials in Greece

Netherlands3 sites

  • Maastricht Universitair Medisch Centrum

    Maastricht, 6229 HX

  • HagaZiekenhuis

    The Hague, South Holland, 2545 AA

  • Isala

    Zwolle, 8025 AB

Other trials in Netherlands

Norway2 sites

  • Oslo Universitetssykehus Ullevål

    Oslo, 0450

  • Stavanger Universitetssykehus

    Stavanger, 4011

Other trials in Norway

Austria1 site

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

About this study

Official title: A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

Read the detailed description

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.

Being tested
Elranatamab, Lenalidomide
Keywords
BCMA, Multiple Myeloma, Newly diagnosed, Elranatamab, Targeted T-cell, MagnetisMM, MM7, Phase 3, B-cell Maturation Antigen, monoclonal antibody, Stem cell transplant, Autologous stem cell transplant (ASCT), Hematologic disease, Minimum residual disease, Lenalidomide
Medical subject headings
Multiple Myeloma, Hematologic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ElranatamabDrug

    BCMA-CD3 bispecific antibody

  • LenalidomideDrug

    Immunomodulatory drug

  • LenalidomideDrug

    Immunomodulatory drug

  • ElranatamabDrug

    BCMA-CD3 bispecific antibody

Study groups in NCT05317416
Study groupRoleWhat they receive
Arm A - Part 1ExperimentalElranatamab
Receives: Drug: Elranatamab
Arm B - Part 1Active comparatorLenalidomide
Receives: Drug: Lenalidomide
Arm B - Part 2Active comparatorLenalidomide
Receives: Drug: Lenalidomide
Arm C - Part 2ExperimentalElranatamab
Receives: Drug: Elranatamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival

    Progression Free Survival assessed by Blinded Independent Central review per IMWG response criteria

    Measured: Assessed for up to approximately 5 years

Secondary outcomes (20)

  1. Minimal residual disease Negative rate

    per IMWG as assessed via next generation sequencing (NGS)

    Measured: 12 months after randomization

  2. Progression Free Survival by BICR per IMWG in IMWG 2025 high-risk participants

    Progression Free Survival by BICR per IMWG in IMWG 2025 high-risk participants

    Measured: Assessed up to approximately 5 years

  3. PFS by BICR per IMWG in IMWG 2025 standard-risk participant

    PFS by BICR per IMWG in IMWG 2025 standard-risk participant

    Measured: Assessed up to approximately 5 years

  4. Overall Survival

    Defined as the time from randomization until death due to any cause

    Measured: Assessed for up to approximately 5 years

  5. MRD-negative rate per IMWG 2025

    Assessed via NGS in IMWG 2025 subgroups

    Measured: 12 months after randomization

  6. Sustained MRD negative rate

    Sustained Minimal Residual Disease negative rate per IMWG criteria as assessed via Next Generation Sequencing

    Measured: 24 months after randomization

  7. Progression Free Survival

    Progression Free Survival by investigator per IMWG response criteria

    Measured: Assessed for up to approximately 5 years

  8. Overall minimal residual disease negative rate

    Minimal residual disease negative rate per IMWG criteria

    Measured: Assessed for up to approximately 5 years

  9. Duration of minimal residual disease negativity

    Minimal residual disease negativity per IMWG criteria

    Measured: Assessed for up to approximately 5 years

  10. Sustained minimal residual disease negativity rate

    Minimal residual disease negativity per IMWG criteria that has lasted a minimum of 12 months

    Measured: Assessed for up to approximately 5 years

  11. Complete response rate

    Complete response rate by blinded independent central review and by investigator per IMWG criteria

    Measured: Assessed for up to approximately 5 years

  12. Duration of complete response

    Duration of complete response by blinded independent central review and by investigator per IMWG criteria

    Measured: Assessed for up to approximately 5 years

  13. Progression Free Survival 2

    Progression Free Survival to the date of second objective disease progression by investigator per IMWG response criteria

    Measured: Assessed for up to approximately 5 years

  14. Frequency of adverse events

    Adverse event as characterized by type, frequency, severity per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5, seriousness and relationship to the study intervention

    Measured: Up to 90 days after last dose

  15. Severity of Cytokine Release Syndrome and Immune effector Cell Associated Neurotoxicity syndrome

    Cytokine Release Syndrome and Immune effector Cell Associated Neurotoxicity syndrome severity assessed per ASH-ASTCT criteria

    Measured: Assessed for up to approximately 5 years

  16. Pre-dose concentrations of elranatamab

    Pharmacokinetics of elranatamab (trough concentrations of elranatamab)

    Measured: Assessed for up to approximately 5 years

  17. Post-dose concentrations of elranatamab

    Pharmacokinetics of elranatamab (Post-dose serum concentrations of elranatamab)"

    Measured: Assessed for up to approximately 5 years

  18. Incidence and titers of Anti-Drug Antibody and Neutralizing Antibody against elranatamab

    Immunogenicity of elranatamab

    Measured: Assessed for up to approximately 5 years

  19. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30

    Higher scores on the functional scales represent higher levels of functioning. Higher scores on the global health status/quality of life scale represent higher health status/quality of life. Higher scores on symptom scales/items represent a greater presence of symptoms

    Measured: Assessed for up to approximately 5 years

  20. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20

    Higher scores on the functioning subscales (body image, future perspective) represent higher levels of functioning, whereas higher scores on the symptom subscales (disease symptoms, side effects) represent a greater presence of symptoms

    Measured: Assessed for up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start25 Mar 2022
  3. Primary completion4 Aug 2027 (estimated)
  4. Study completion31 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
854 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05317416
Sponsor's protocol ID
C1071007
Other IDs
MagnetisMM-7, 2023-508897-27-00, 2023
Acronym
MagnetisMM-7
Status last verified
Apr 2026
First submitted
18 Mar 2022
Last updated
16 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Elranatamab and Lenalidomide in people with Multiple Myeloma, run by Pfizer at 209 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 209 sites in United States, Spain, Brazil, Japan, Australia and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Assessed for up to approximately 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05317416.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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