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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT05623020

Registry updated: 2026-09-25
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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. 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.

Interventions

  • Elranatamab (Drug)
    Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
  • Daratumumab (Drug)
    Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
  • Lenalidomide (Drug)
    Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
  • Dexamethasone (Drug)
    Randomized
  • Bortezomib (Drug)
    Randomized

Eligibility criteria

Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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. * 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.

Conditions

Multiple Myeloma

Locations

  • Jupiter Medical Center/Anderson Family Cancer Institute — Jupiter, Florida, United States
  • NHO Revive Research Institute, LLC — Lincoln, Nebraska, United States
  • Renown Health Medical Oncology — Reno, Nevada, United States
  • Renown Office of Clinical Research — Reno, Nevada, United States
  • Renown Regional Medical Center — Reno, Nevada, United States
  • MSK Basking Ridge — Basking Ridge, New Jersey, United States
  • MSK Monmouth — Middletown, New Jersey, United States
  • MSK Bergen — Montvale, New Jersey, United States
  • MSK Commack — Commack, New York, United States
  • MSK Westchester — Harrison, New York, United States
  • Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). — New York, New York, United States
  • Memorial Sloan Kettering Cancer Center-Main Campus — New York, New York, United States
  • MSK Nassau — Uniondale, New York, United States
  • The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
  • LDS Hospital — Salt Lake City, Utah, United States
  • Intermountain Cancer Center St. George — St. George, Utah, United States
  • St. George Regional Hospital — St. George, Utah, United States
  • Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
  • Pindara Private Hospital — Benowa, Queensland, Australia
  • St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia
  • Epworth Freemasons — Melbourne, Victoria, Australia
  • The Alfred Hospital — Melbourne, Victoria, Australia
  • Epworth Healthcare — Richmond, Victoria, Australia
  • Universitätsklinikum St. Pölten — Sankt Pölten, Lower Austria, Austria
  • Krankenhaus der Barmherzigen Schwestern Wien — Vienna, State of Vienna, Austria
  • Medizinische Universität Graz — Graz, Styria, Austria
  • Ordensklinikum Linz — Linz, Upper Austria, Austria
  • Klinikum Wels-Grieskirchen GmbH — Wels, Upper Austria, Austria
  • Landeskrankenhaus Feldkirch — Rankweil, Vorarlberg, Austria
  • Uniklinikum Salzburg — Salzburg, Austria
  • Medizinische Universität Wien — Vienna, Austria
  • Clinique Saint Pierre — Ottignies, Brabant Wallon, Belgium
  • UZ Brussel — Brussels, Bruxelles-capitale, Région de, Belgium
  • Grand Hôpital de Charleroi — Gilly, Hainaut, Belgium
  • Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi — Yvoir, Namur, Belgium
  • AZ Sint-Jan Brugge-Oostende AV — Bruges, West-vlaanderen, Belgium
  • AZ Delta vzw — Roeselare, West-vlaanderen, Belgium
  • Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa — Porto Alegre, Rio Grande do Sul, Brazil
  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP) — Ribeirão Preto, São Paulo, Brazil
  • Arthur J.E Child Comprehensive Cancer Centre — Calgary, Alberta, Canada
  • Cross Cancer Institute — Edmonton, Alberta, Canada
  • Dr. Everett Chalmers Regional Hospital — Fredericton, New Brunswick, Canada
  • QEII Health Sciences Centre — Halifax, Nova Scotia, Canada
  • Nova Scotia Health Authority — Halifax, Nova Scotia, Canada
  • Princess Margaret Cancer Centre — Toronto, Ontario, Canada
  • Peking University Third Hospital — Beijing, Beijing Municipality, China
  • Fujian Medical University Union Hospital — Fuzhou, Fujian, China
  • Southern Medical University Nanfang Hospital — Guangzhou, Guangdong, China
  • Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China
  • Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China
  • Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China
  • The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China
  • The first hospital of jilin university — Changchun, Jilin, China
  • Tongji University - Shanghai Fourth People's Hospital — Shanghai, Shanghai Municipality, China
  • Institute of hematology&blood disease hospital — Tianjin, Tianjin Municipality, China
  • The first Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
  • The first Affiliated hospital of Wenzhou medical University — Wenzhou, Zhejiang, China
  • Fakultní nemocnice Brno Bohunice — Brno, Brno-město, Czechia
  • Fakultni nemocnice Olomouc — Olomouc, Czechia
  • Vseobecna fakultni nemocnice v Praze — Prague, Czechia
  • Kuopion Yliopistollinen Sairaala — Kuopio, Northern Savonia, Finland
  • Turku University Hospital — Turku, Southwest Finland, Finland
  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) — Helsinki, Finland
  • Oulu University Hospital — Oulu, Finland
  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet — Nice, Alpes-maritimes, France
  • Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE — Toulouse, Haute-garonne, France
  • Centre Hospitalier Universitaire de Poitiers — Poitiers, Vienne, France
  • Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu — Nantes, France
  • Hôpital Saint Antoine — Paris, France
  • Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau — Tours, France
  • Gustave Roussy — Villejuif, France
  • Universitaetsklinikum Freiburg — Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Universitaetsklinikum Tuebingen — Tübingen, Baden-Wurttemberg, Germany
  • Universitaetsklinikum Ulm — Ulm, Baden-Wurttemberg, Germany
  • Universitätsmedizin Johannes Gutenberg Universität Mainz — Mainz, Rhineland-Palatinate, Germany
  • Universitätsklinikum Aachen — Aachen, Germany
  • Städtisches Klinikum Braunschweig — Braunschweig, Germany
  • Klinikum Chemnitz — Chemnitz, Germany
  • Asklepiosklinik Altona — Hamburg, Germany
  • Evangelismos General Hospital of Athens — Athens, Attikí, Greece
  • Alexandra General Hospital of Athens — Athens, Attikí, Greece
  • "Theagenio" Cancer Hospital of Thessaloniki — Thessaloniki, Kentrikí Makedonía, Greece
  • Evangelismos General Hospital of Athens — Athens, Greece
  • University Hospital of Ioannina — Ioannina, Ípeiros, Greece
  • Rabin Medical Center — Petah Tikva, Central District, Israel
  • The Edmond and Lily Safra Children's Hospital; The Chaim Sheba Medical Center — Ramat Gan, Central District, Israel
  • Hadassah Medical Center — Jerusalem, Jerusalem, Israel
  • Soroka Medical Center — Beersheba, Southern District, Israel
  • Sourasky Medical Center — Tel Aviv, TELL ABĪB, Israel
  • IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori- IRST S.r.l — Meldola (Fc), Emilia-Romagna, Italy
  • AUSL di Piacenza — Piacenza, Emilia-Romagna, Italy
  • Ospedale Santa Maria delle Croci — Ravenna, Emilia-Romagna, Italy
  • IRCCS Casa Sollievo della Sofferenza — San Giovanni Rotondo, FG, Italy
  • Cro-Irccs — Aviano, Friuli Venezia Giulia, Italy
  • Fondazione IRCCS San Gerardo dei Tintori — Monza, Lombardy, Italy
  • Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino — Turin, Piedmont, Italy
  • A.O.U. Policlinico Paolo Giaccone — Palermo, Sicily, Italy
  • Azienda Ospedaliero Universitaria Pisana — Pisa, Tuscany, Italy
  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII — Bergamo, Italy
  • Istituto Europeo di Oncologia IRCCS — Milan, Italy
  • ASL PESCARA-Presidio Ospedaliero Pescara — Pescara, Italy
  • Azienda Sanitaria Locale di Pescara — Pescara, Italy
  • AOU Policlinico Umberto I — Roma, Italy
  • Azienda Ospedaliero Universitaria Senese — Siena, Italy
  • University of Fukui Hospital — Yoshida-gun, Fukui, Japan
  • Gunma University Hospital — Maebashi, Gunma, Japan
  • Iwate Medical University Hospital — Yahaba-cho, Iwate, Japan
  • Tohoku University Hospital — Sendai, Miyagi, Japan
  • Shizuoka Cancer Center — Nagaizumi-cho, Shizuoka, Japan
  • Japanese Red Cross Medical Center — Shibuya-ku, Tokyo, Japan
  • Kyushu University Hospital — Fukuoka, Japan
  • National Hospital Organization Okayama Medical Center — Okayama, Japan
  • Osaka Metropolitan University Hospital — Osaka, Japan
  • Yamagata University Hospital — Yamagata, Japan
  • Albert Schweitzer Ziekenhuis, locatie Dordwijk — Dordrecht, South Holland, Netherlands
  • Auckland City Hospital — Grafton, Auckland, New Zealand
  • Waikato Hospital — Hamilton, Waikato Region, New Zealand
  • Capital, Coast and Hutt Valley District - Wellington Regional Hospital — Newtown, Wellington Region, New Zealand
  • North Shore Hospital — Auckland, New Zealand
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu — Wroclaw, Lower Silesian Voivodeship, Poland
  • Uniwersyteckie Centrum Kliniczne — Gdansk, Pomeranian Voivodeship, Poland
  • Pratia Onkologia Katowice — Katowice, Silesian Voivodeship, Poland
  • Auxilio Mutuo Cancer Center — San Juan, Puerto Rico
  • Chonnam National University Hwasun Hospital — Hwasun-gun, Jeonranamdo, South Korea
  • Seoul National University Bundang Hospital — Seongnam, Kyǒnggi-do, South Korea
  • Seoul National University Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • Samsung Medical Center — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital) — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • The Catholic Univ. of Korea Seoul St. Mary's Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • Ewha Womans University Seoul Hospital — Seoul, Seoul-teukbyeolsi [seoul], South Korea
  • CHUS - Hospital Clinico Universitario — Santiago de Compostela, A Coruña [LA Coruña], Spain
  • Institut Català d'Oncologia (ICO) - Badalona — Badalona, Barcelona [barcelona], Spain
  • Institut Català d'Oncologia - L'Hospitalet — L'Hospitalet Del Llobregat, Barcelona [barcelona], Spain
  • Hospital Universitari Mutua Terrassa — Terrassa, Barcelona [barcelona], Spain
  • Hospital Universitario Marqués de Valdecilla — Santander, Cantabria, Spain
  • Hospital Clínic de Barcelona — Barcelona, Catalunya [cataluña], Spain
  • Institut Català d'Oncologia (ICO) - Girona — Girona, Girona [gerona], Spain
  • Clinica Universidad de Navarra — Madrid, Madrid, Comunidad de, Spain
  • Clinica Universidad de Navarra — Pamplona, Navarre, Spain
  • Hospital Universitario Doctor Peset — Valencia, València, Spain
  • Hospital San Pedro de Alcántara — Cáceres, Spain
  • Hospital La Princesa — Madrid, Spain
  • Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain
  • H.R.U Málaga - Hospital General — Málaga, Spain
  • Hospital Universitari i Politecnic La Fe — Valencia, Spain
  • Inselspital Bern — Bern, Canton of Bern, Switzerland
  • Kantonsspital Winterthur — Winterthur, Switzerland
  • China Medical University Hospital — Taichung, Taiwan
  • Taichung Veterans General Hospital — Taichung, Taiwan
  • National Taiwan University Hospital — Taipei, Taiwan
  • Chang Gung Medical Foundation-Linkou Branch — Taoyuan, Taiwan
  • Leicester Royal Infirmary — Leicester, England, United Kingdom
  • Guy's & St Thomas' NHS Foundation Trust — London, London, CITY of, United Kingdom
  • Western General Hospital — Edinburgh, Midlothian, United Kingdom
  • Churchill Hospital — Oxford, Oxfordshire, United Kingdom
  • Royal Stoke University Hospital — Stoke-on-Trent, Staffordshire, United Kingdom
  • Queen Elizabeth Hospital Birmingham — Birmingham, United Kingdom
  • University Hospital of Wales — Cardiff, United Kingdom
  • The Beatson West of Scotland Cancer Centre — Glasgow, United Kingdom
  • Royal Berkshire Hospital — Reading, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record