AzTrials
AzTrials

Multiple MyelomaPhase 3MagnetisMM-6NCT05623020

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

A Phase 3 study testing Elranatamab, Daratumumab and Lenalidomide in people with Multiple Myeloma, run by Pfizer at 180 sites in 25 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… 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, Daratumumab and Lenalidomide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,060 participants
Where
180 sitesin 25 countries
Study dates
10 Nov 2022to 3 Oct 2033
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 multiple myeloma (MM) 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 (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 to lambda FLC ratio (<0.26 or >1.65).
  • Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age <65 years with comorbidities impacting the possibility of transplant.
Show all 12Show fewer
  • Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible defined as:
  • Participants not considered candidates for high-dose chemotherapy and ASCT due to age or
  • Participants with important comorbidities likely to have a negative impact on tolerability 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 baseline severity or CTCAE Grade ≤1.

Who cannot join

  • Smoldering Multiple Myeloma.
  • Monoclonal gammopathy of undetermined significance.
  • Waldenströms Macroglobulinemia
  • Plasma cell leukemia.
  • Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited 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 for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator.
Show all 10Show fewer
  • For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD.
  • For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, total of 160 mg dexamethasone or equivalent before the first dose of study intervention). A cumulative dose of systemic corticosteroids equivalent to ≥20 mg of dexamethasone during screening.
  • Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.
  • Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.

Trial locations and contacts

180 sites in 25 countries. Contact the study team or a site near you to ask about taking part.

Pfizer CT.gov Call Center contact

1-800-718-1021

ClinicalTrials.gov_Inquiries@pfizer.com

180 sites in 25 countries

United States34 sites, 34 recruiting

  • MSK Basking Ridge

    Basking Ridge, New Jersey, 07920

    Recruiting

  • MSK Commack

    Commack, New York, 11725

    Recruiting

  • Sylvester Comprehensive Cancer Center - The Lennar Foundation Medical Center

    Coral Gables, Florida, 33146

    Recruiting

  • Sylvester Comprehensive Cancer Center - Coral Springs

    Coral Springs, Florida, 33065

    Recruiting

  • Gulf Health Hospitals, Inc. d/b/a Infirmary Cancer Care - Malbis

    Daphne, Alabama, 36526

    Recruiting

  • Gulf Health Hospitals, Inc. d/b/a Thomas Medical Center

    Daphne, Alabama, 36526

    Recruiting

  • University of Miami Hospital and Clinics Deerfield Beach

    Deerfield Beach, Florida, 33442

    Recruiting

  • Sylvester Comprehensive Cancer Center- Doral

    Doral, Florida, 33166

    Recruiting

  • Gulf Health Hospitals, Inc. d/b/a Infirmary Cancer Care - Fairhope

    Fairhope, Alabama, 36532

    Recruiting

  • MSK Westchester

    Harrison, New York, 10604

    Recruiting

  • Sylvester Comprehensive Cancer Center - Hollywood

    Hollywood, Florida, 33021

    Recruiting

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

    Recruiting

  • Jupiter Medical Center/Anderson Family Cancer Institute

    Jupiter, Florida, 33458

    Recruiting

  • NHO Revive Research Institute, LLC

    Lincoln, Nebraska, 68506

    Recruiting

  • Sylvester Comprehensive Cancer Center

    Miami, Florida, 33136

    Recruiting

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

    Recruiting

  • Sylvester Comprehensive Cancer Center Kendall

    Miami, Florida, 33176

    Recruiting

  • MSK Monmouth

    Middletown, New Jersey, 07748

    Recruiting

  • Mobile Infirmary Association d/b/a Mobile Infirmary Medical Center

    Mobile, Alabama, 36606

    Recruiting

  • Gulf Health Hospitals, Inc. d/b/a Infirmary Cancer Care - Mobile

    Mobile, Alabama, 36607

    Recruiting

  • Mobile Infirmary Medical Center

    Mobile, Alabama, 36607

    Recruiting

  • Mobile Infirmary Association d/b/a Mobile Infirmary Medical Center.

    Mobile, Alabama, 36695

    Recruiting

  • MSK Bergen

    Montvale, New Jersey, 07645

    Recruiting

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

    New York, New York, 10021

    Recruiting

  • Memorial Sloan Kettering Cancer Center-Main Campus

    New York, New York, 10065

    Recruiting

  • Sylvester Comprehensive Cancer Center - Sole Mia

    North Miami, Florida, 33181

    Recruiting

  • Sylvester Comprehensive Cancer Center - Plantation

    Plantation, Florida, 33324

    Recruiting

  • Renown Health Medical Oncology

    Reno, Nevada, 89502

    Recruiting

  • Renown Office of Clinical Research

    Reno, Nevada, 89502

    Recruiting

  • Renown Regional Medical Center

    Reno, Nevada, 89502

    Recruiting

  • LDS Hospital

    Salt Lake City, Utah, 84143

    Recruiting

  • Intermountain Cancer Center St. George

    St. George, Utah, 84790

    Recruiting

  • St. George Regional Hospital

    St. George, Utah, 84790

    Recruiting

  • MSK Nassau

    Uniondale, New York, 11553

    Recruiting

Other trials in United States

Italy15 sites, 15 recruiting

  • Cro-Irccs

    Aviano, Friuli Venezia Giulia, 33081

    Recruiting

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    Bergamo, 24127

    Recruiting

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

    Meldola (Fc), Emilia-Romagna, 47014

    Recruiting

  • Istituto Europeo di Oncologia IRCCS

    Milan, 20141

    Recruiting

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Lombardy, 20900

    Recruiting

  • A.O.U. Policlinico Paolo Giaccone

    Palermo, Sicily, 90127

    Recruiting

  • ASL PESCARA-Presidio Ospedaliero Pescara

    Pescara, 65124

    Recruiting

  • Azienda Sanitaria Locale di Pescara

    Pescara, 65124

    Recruiting

  • AUSL di Piacenza

    Piacenza, Emilia-Romagna, 29121

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56126

    Recruiting

  • Ospedale Santa Maria delle Croci

    Ravenna, Emilia-Romagna, 48121

    Recruiting

  • AOU Policlinico Umberto I

    Roma, 00161

    Recruiting

  • IRCCS Casa Sollievo della Sofferenza

    San Giovanni Rotondo, FG, 71013

    Recruiting

  • Azienda Ospedaliero Universitaria Senese

    Siena, 53100

    Recruiting

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

    Turin, Piedmont, 10126

    Recruiting

Other trials in Italy

Spain15 sites, 15 recruiting

  • Institut Català d'Oncologia (ICO) - Badalona

    Badalona, Barcelona [barcelona], 08916

    Recruiting

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [cataluña], 08036

    Recruiting

  • Hospital San Pedro de Alcántara

    Cáceres, 10003

    Recruiting

  • Institut Català d'Oncologia (ICO) - Girona

    Girona, Girona [gerona], 17007

    Recruiting

  • Institut Català d'Oncologia - L'Hospitalet

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

    Recruiting

  • Clinica Universidad de Navarra

    Madrid, Madrid, Comunidad de, 28027

    Recruiting

  • Hospital La Princesa

    Madrid, 28006

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040

    Recruiting

  • H.R.U Málaga - Hospital General

    Málaga, 29010

    Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarre, 31008

    Recruiting

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

    Recruiting

  • CHUS - Hospital Clinico Universitario

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

    Recruiting

  • Hospital Universitari Mutua Terrassa

    Terrassa, Barcelona [barcelona], 08221

    Recruiting

  • Hospital Universitario Doctor Peset

    Valencia, València, 46017

    Recruiting

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

    Recruiting

Other trials in Spain

China12 sites, 12 recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100091

    Recruiting

  • The first hospital of jilin university

    Changchun, Jilin, 130021

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

    Recruiting

  • Southern Medical University Nanfang Hospital

    Guangzhou, Guangdong, 510515

    Recruiting

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510555

    Recruiting

  • The first Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

    Recruiting

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

    Recruiting

  • Tongji University - Shanghai Fourth People's Hospital

    Shanghai, Shanghai Municipality, 200434

    Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Recruiting

  • Institute of hematology&blood disease hospital

    Tianjin, Tianjin Municipality, 300020

    Recruiting

  • The first Affiliated hospital of Wenzhou medical University

    Wenzhou, Zhejiang, 325000

    Recruiting

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

    Wuhan, Hubei, 430030

    Recruiting

Other trials in China

Japan10 sites, 10 recruiting

  • Kyushu University Hospital

    Fukuoka, 812-8582

    Recruiting

  • Gunma University Hospital

    Maebashi, Gunma, 371-8511

    Recruiting

  • Shizuoka Cancer Center

    Nagaizumi-cho, Shizuoka, 411-8777

    Recruiting

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

    Recruiting

  • Osaka Metropolitan University Hospital

    Osaka, 545-0051

    Recruiting

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

    Recruiting

  • Japanese Red Cross Medical Center

    Shibuya-ku, Tokyo, 150-8935

    Recruiting

  • Iwate Medical University Hospital

    Yahaba-cho, Iwate, 028-3695

    Recruiting

  • Yamagata University Hospital

    Yamagata, 990-9585

    Recruiting

  • University of Fukui Hospital

    Yoshida-gun, Fukui, 910-1193

    Recruiting

Other trials in Japan

United Kingdom9 sites, 9 recruiting

  • Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2TH

    Recruiting

  • University Hospital of Wales

    Cardiff, CF14 4XW

    Recruiting

  • Western General Hospital

    Edinburgh, Midlothian, EH4 2XU

    Recruiting

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN

    Recruiting

  • Leicester Royal Infirmary

    Leicester, England, LE1 5WW

    Recruiting

  • Guy's & St Thomas' NHS Foundation Trust

    London, London, CITY of, SE1 9RT

    Not yet recruiting

  • Churchill Hospital

    Oxford, Oxfordshire, OX3 7LE

    Recruiting

  • Royal Berkshire Hospital

    Reading, RG1 5AN

    Recruiting

  • Royal Stoke University Hospital

    Stoke-on-Trent, Staffordshire, ST4 6QG

    Recruiting

Other trials in United Kingdom

Austria8 sites, 8 recruiting

  • Medizinische Universität Graz

    Graz, Styria, 8036

    Recruiting

  • Ordensklinikum Linz

    Linz, Upper Austria, 4020

    Not yet recruiting

  • Landeskrankenhaus Feldkirch

    Rankweil, Vorarlberg, 6830

    Recruiting

  • Uniklinikum Salzburg

    Salzburg, 5020

    Recruiting

  • Universitätsklinikum St. Pölten

    Sankt Pölten, Lower Austria, 3100

    Recruiting

  • Krankenhaus der Barmherzigen Schwestern Wien

    Vienna, State of Vienna, 1060

    Recruiting

  • Medizinische Universität Wien

    Vienna, 1090

    Recruiting

  • Klinikum Wels-Grieskirchen GmbH

    Wels, Upper Austria, 4600

    Recruiting

Other trials in Austria

Germany8 sites, 8 recruiting

  • Universitätsklinikum Aachen

    Aachen, 52074

    Recruiting

  • Städtisches Klinikum Braunschweig

    Braunschweig, 38114

    Recruiting

  • Klinikum Chemnitz

    Chemnitz, 09116

    Recruiting

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

    Recruiting

  • Asklepiosklinik Altona

    Hamburg, 22763

    Recruiting

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

    Recruiting

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

    Recruiting

  • Universitaetsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89081

    Recruiting

Other trials in Germany

Canada7 sites, 7 recruiting

  • Arthur J.E Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Not yet recruiting

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

    Recruiting

  • Dr. Everett Chalmers Regional Hospital

    Fredericton, New Brunswick, E3B 5N5

    Recruiting

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 2Y9

    Recruiting

  • Nova Scotia Health Authority

    Halifax, Nova Scotia, B3S 0H6

    Recruiting

  • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Univer

    Sherbrooke, Quebec, J1H 5N4

    Recruiting

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

    Recruiting

Other trials in Canada

France7 sites, 7 recruiting

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

    Nantes, 44093 Cedex 1

    Recruiting

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

    Nice, Alpes-maritimes, 06200

    Recruiting

  • Hôpital Saint Antoine

    Paris, 75012

    Recruiting

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne, 86021

    Recruiting

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

    Toulouse, Haute-garonne, 31100

    Recruiting

  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

    Tours, 37032

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Not yet recruiting

Other trials in France

South Korea7 sites, 7 recruiting

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeonranamdo, 58128

    Recruiting

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620

    Recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 03080

    Recruiting

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [seoul], 06351

    Recruiting

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

    Seoul, Seoul-teukbyeolsi [seoul], 06591

    Recruiting

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

    Seoul, Seoul-teukbyeolsi [seoul], 06591

    Recruiting

  • Ewha Womans University Seoul Hospital

    Seoul, Seoul-teukbyeolsi [seoul], 07804

    Recruiting

Other trials in South Korea

Australia6 sites, 6 recruiting

  • Pindara Private Hospital

    Benowa, Queensland, 4217

    Recruiting

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

    Recruiting

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

    Recruiting

  • Epworth Freemasons

    Melbourne, Victoria, 3002

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Recruiting

  • Epworth Healthcare

    Richmond, Victoria, 3121

    Recruiting

Other trials in Australia

Belgium6 sites, 6 recruiting

  • AZ Sint-Jan Brugge-Oostende AV

    Bruges, West-vlaanderen, 8000

    Recruiting

  • UZ Brussel

    Brussels, Bruxelles-capitale, Région de, 1090

    Recruiting

  • Grand Hôpital de Charleroi

    Gilly, Hainaut, 6060

    Recruiting

  • Clinique Saint Pierre

    Ottignies, Brabant Wallon, 1340

    Recruiting

  • AZ Delta vzw

    Roeselare, West-vlaanderen, 8800

    Recruiting

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

    Yvoir, Namur, 5530

    Recruiting

Other trials in Belgium

Greece5 sites, 5 recruiting

  • Evangelismos General Hospital of Athens

    Athens, Attikí, 106 76

    Recruiting

  • Alexandra General Hospital of Athens

    Athens, Attikí, 115 28

    Recruiting

  • Evangelismos General Hospital of Athens

    Athens, 10676

    Recruiting

  • University Hospital of Ioannina

    Ioannina, Ípeiros, 455 00

    Recruiting

  • "Theagenio" Cancer Hospital of Thessaloniki

    Thessaloniki, Kentrikí Makedonía, 540 07

    Recruiting

Other trials in Greece

Israel5 sites, 5 recruiting

  • Soroka Medical Center

    Beersheba, Southern District, 8410101

    Recruiting

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001

    Recruiting

  • Rabin Medical Center

    Petah Tikva, Central District, 4910021

    Recruiting

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

    Ramat Gan, Central District, 5265601

    Recruiting

  • Sourasky Medical Center

    Tel Aviv, TELL ABĪB, 6423906

    Recruiting

Other trials in Israel

Finland4 sites, 4 recruiting

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

    Helsinki, 00029

    Recruiting

  • Kuopion Yliopistollinen Sairaala

    Kuopio, Northern Savonia, 70210

    Recruiting

  • Oulu University Hospital

    Oulu, 90220

    Recruiting

  • Turku University Hospital

    Turku, Southwest Finland, 20520

    Recruiting

Other trials in Finland

New Zealand4 sites, 4 recruiting

  • North Shore Hospital

    Auckland, 0622

    Recruiting

  • Auckland City Hospital

    Grafton, Auckland, 1023

    Recruiting

  • Waikato Hospital

    Hamilton, Waikato Region, 3204

    Recruiting

  • Capital, Coast and Hutt Valley District - Wellington Regional Hospital

    Newtown, Wellington Region, 6021

    Recruiting

Other trials in New Zealand

Taiwan4 sites, 3 recruiting

  • China Medical University Hospital

    Taichung, 404332

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 407

    Recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    Active, not recruiting

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan, 333

    Recruiting

Other trials in Taiwan

Czechia3 sites, 3 recruiting

  • Fakultní nemocnice Brno Bohunice

    Brno, Brno-město, 625 00

    Recruiting

  • Fakultni nemocnice Olomouc

    Olomouc, 779 00

    Recruiting

  • Vseobecna fakultni nemocnice v Praze

    Prague, 12808

    Recruiting

Other trials in Czechia

Poland3 sites, 1 recruiting

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-214

    Recruiting

  • Pratia Onkologia Katowice

    Katowice, Silesian Voivodeship, 40-519

    Active, not recruiting

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

    Wroclaw, Lower Silesian Voivodeship, 50-367

    Active, not recruiting

Other trials in Poland

Argentina2 sites, 2 recruiting

  • Hospital Privado Universitario de Córdoba

    Córdoba, Córdoba Province, 5016

    Not yet recruiting

  • Sanatorio de La Mujer

    Rosario, Santa Fe Province, S2000ORE

    Not yet recruiting

Other trials in Argentina

Brazil2 sites, 2 recruiting

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

    Porto Alegre, Rio Grande do Sul, 90110-270

    Not yet recruiting

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

    Ribeirão Preto, São Paulo, 14051-140

    Recruiting

Other trials in Brazil

Switzerland2 sites, 2 recruiting

  • Inselspital Bern

    Bern, Canton of Bern, 3010

    Recruiting

  • Kantonsspital Winterthur

    Winterthur, 8401

    Recruiting

Other trials in Switzerland

Netherlands1 site, 1 recruiting

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk

    Dordrecht, South Holland, 3318 AT

    Recruiting

Other trials in Netherlands

Puerto Rico1 site, 1 recruiting

  • Auxilio Mutuo Cancer Center

    San Juan, 00917

    Recruiting

Other trials in Puerto Rico

About this study

Official title: AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA

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.

Being tested
Elranatamab, Daratumumab, Lenalidomide, Dexamethasone, Bortezomib
Keywords
Elranatamab, PF-06863135, B-Cell Maturation Antigen, Daratumumab, Lenalidomide, Multiple myeloma, MagnetisMM-6, Bortezomib
Medical subject headings
Multiple Myeloma

What participants receive

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

  • ElranatamabDrug

    Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

  • DaratumumabDrug

    Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

  • LenalidomideDrug

    Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.

  • DexamethasoneDrug

    Randomized

  • BortezomibDrug

    Randomized

Study groups in NCT05623020
Study groupRoleWhat they receive
Part 1, Dose Level 1: Elranatamab + Daratumumab + LenalidomideExperimentalNot described
Receives: Drug: Elranatamab; Drug: Daratumumab; Drug: Lenalidomide
Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + LenalidomideExperimentalNot described
Receives: Drug: Elranatamab; Drug: Daratumumab; Drug: Lenalidomide
Part 2 Randomized Arm A: Elranatamab + Daratumumab + LenalidomideExperimentalNot described
Receives: Drug: Elranatamab; Drug: Daratumumab; Drug: Lenalidomide
Part 2 Randomized Arm B: Daratumumab + Bortezomib + Lenalidomide + DexamethasoneActive comparatorNot described
Receives: Drug: Daratumumab; Drug: Lenalidomide; Drug: Dexamethasone; Drug: Bortezomib
Part 1: Elranatamab + LenalidomideExperimentalNot described
Receives: Drug: Elranatamab; Drug: Lenalidomide

What is being measured

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

  1. Part 1 Dose Limiting Toxicity

    Measured: From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide

  2. Part 2: Progression free survival per IMWG

    Measured: From randomization up to 97 months.

  3. Part 2: Minimal Residual Disease negative CR rate

    Measured: At 12 months after randomization

Secondary outcomes (18)

  1. Overall Survival

    Measured: From date of randomization up to 97 months

  2. Overall minimal residual disease negative CR rate

    Measured: From date of randomization up to 97 months

  3. Sustained MRD negative CR rate (Part 2)

    Measured: From date of randomization up to 97 months

  4. Duration of minimal residual disease negative CR (Part 2)

    Measured: From date of minimal residual disease negative CR status up to 97 months

  5. PFS by investigator

    Measured: From date of randomization up to 97 months

  6. PFS2 by investigator (Part 2)

    Measured: From the date of randomization up to 97 months

  7. Objective Response Rate

    Measured: From the date of randomization up to 97 months

  8. Complete Response Rate

    Measured: From the date of randomization up to 97 months

  9. Time to Response

    Measured: From the date of randomization to date of confirmed objective response up to 97 months

  10. Duration of Response

    Measured: From the date of confirmed objective response up to 97 months

  11. Duration of Complete Response

    Measured: From the date of confirmed complete response up to 97 months

  12. Frequency of treatment-emergent adverse events

    Measured: From the date of first dose of study intervention up to 97 months

  13. Frequency of abnormal laboratory results

    Measured: From the date of first dose of study intervention up to 97 months

  14. Pharmacokinetics of elranatamab when used in the elranatamab + daratumumab + lenalidomide or elranatamab + lenalidomide combinations

    Predose and post dose concentrations of elranatamab

    Measured: From date of first dose of study intervention up to 97 months

  15. Incidence of Anti-Drug Antibody against elranatamab

    Immunogenicity of elranatamab

    Measured: From date of first dose of study intervention up to 97 months

  16. Pharmacokinetics of daratumumab and lenalidomide when used in the elranatamab+daratumumab+lenalidomide or elranatamab+lenalidomide combinations (Part 1)

    Predose concentrations of daratumumab and lenalidomide

    Measured: From date of first dose of study intervention up to 97 months

  17. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (Part 2)

    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 the symptom scales/items represent a greater presence of symptoms.

    Measured: From date the informed consent is signed up to 97 months

  18. Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Myeloma 20 (Part 2)

    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: From date the informed consent is signed up to 97 months

Timeline

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

  1. First posted21 Nov 2022
  2. Study start10 Nov 2022
  3. Primary completion18 Oct 2030 (estimated)
  4. Study completion3 Oct 2033 (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
1,060 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05623020
Sponsor's protocol ID
C1071006
Other IDs
MAGNETISMM-6, 2024-514139-50-00
Acronym
MagnetisMM-6
Status last verified
Oct 2026
First submitted
26 Oct 2022
Last updated
27 Oct 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, Daratumumab and Lenalidomide in people with Multiple Myeloma, run by Pfizer at 180 sites in 25 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 12 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 180 sites in United States, Italy, Spain, China, Japan and 20 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?

Contact Pfizer CT.gov Call Center (1-800-718-1021, ClinicalTrials.gov_Inquiries@pfizer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 Dose Limiting Toxicity (time frame: From the first dose of elranatamab/first full dose in combination with EDR until 28 days (+/- visit window) from the first administration of elranatamab with daratumumab and lenalidomide). The study lists 3 primary outcomes in all. 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 NCT05623020.

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 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in