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Promising new combo aims to control multiple myeloma without transplant

NCT ID NCT05623020

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 25, 2026 · Updated 4 times

Summary

This study tests whether a new drug combination (elranatamab, daratumumab, and lenalidomide) works better than a standard combination for people newly diagnosed with multiple myeloma who are not eligible for a stem cell transplant. The trial involves about 1,116 participants and will measure how long the cancer stays under control and whether it can be reduced to undetectable levels. The goal is to improve disease control, not to cure the disease, as ongoing treatment is expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,116 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2022

Expected to finish

Oct 2033

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    136 sites in 24 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • "Theagenio" Cancer Hospital of Thessaloniki

    RECRUITING

    Thessaloniki, Kentrikí Makedonía, 540 07, Greece

  • A.O.U. Policlinico Paolo Giaccone

    RECRUITING

    Palermo, Sicily, 90127, Italy

  • AOU Policlinico Umberto I

    RECRUITING

    Roma, 00161, Italy

  • ASL PESCARA-Presidio Ospedaliero Pescara

    RECRUITING

    Pescara, 65124, Italy

  • AUSL di Piacenza

    RECRUITING

    Piacenza, Emilia-Romagna, 29121, Italy

  • AZ Delta vzw

    RECRUITING

    Roeselare, West-vlaanderen, 8800, Belgium

  • AZ Sint-Jan Brugge-Oostende AV

    NOT_YET_RECRUITING

    Bruges, West-vlaanderen, 8000, Belgium

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk

    RECRUITING

    Dordrecht, South Holland, 3318 AT, Netherlands

  • Alexandra General Hospital of Athens

    RECRUITING

    Athens, Attikí, 115 28, Greece

  • Asklepiosklinik Altona

    NOT_YET_RECRUITING

    Hamburg, 22763, Germany

  • Auckland City Hospital

    RECRUITING

    Grafton, Auckland, 1023, New Zealand

  • Auxilio Mutuo Cancer Center

    RECRUITING

    San Juan, 00917, Puerto Rico

  • Azienda Ospedaliero Universitaria Pisana

    RECRUITING

    Pisa, Tuscany, 56126, Italy

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

    RECRUITING

    Turin, Piedmont, 10126, Italy

  • Azienda Sanitaria Locale di Pescara

    RECRUITING

    Pescara, 65124, Italy

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

    RECRUITING

    Bergamo, 24127, Italy

  • CHUS - Hospital Clinico Universitario

    RECRUITING

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

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

    RECRUITING

    Nantes, 44093 Cedex 1, France

  • Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

    RECRUITING

    Nice, Alpes-maritimes, 06200, France

  • Centre Hospitalier Universitaire de Poitiers

    RECRUITING

    Poitiers, Vienne, 86021, France

  • Chang Gung Medical Foundation-Linkou Branch

    RECRUITING

    Taoyuan, 333, Taiwan

  • China Medical University Hospital

    RECRUITING

    Taichung, 404332, Taiwan

  • Chonnam National University Hwasun Hospital

    RECRUITING

    Hwasun-gun, Jeonranamdo, 58128, South Korea

  • Churchill Hospital

    RECRUITING

    Oxford, Oxfordshire, OX3 7LE, United Kingdom

  • Clinica Universidad de Navarra

    RECRUITING

    Madrid, Madrid, Comunidad de, 28027, Spain

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Clinique Saint Pierre

    RECRUITING

    Ottignies, Brabant Wallon, 1340, Belgium

  • Cro-Irccs

    RECRUITING

    Aviano, Friuli Venezia Giulia, 33081, Italy

  • Cross Cancer Institute

    NOT_YET_RECRUITING

    Edmonton, Alberta, T6G 1Z2, Canada

  • Dr. Everett Chalmers Regional Hospital

    NOT_YET_RECRUITING

    Fredericton, New Brunswick, E3B 5N5, Canada

  • Epworth Freemasons

    RECRUITING

    Melbourne, Victoria, 3002, Australia

  • Epworth Healthcare

    RECRUITING

    Richmond, Victoria, 3121, Australia

  • Evangelismos General Hospital of Athens

    RECRUITING

    Athens, Attikí, 106 76, Greece

  • Evangelismos General Hospital of Athens

    RECRUITING

    Athens, 10676, Greece

  • Ewha Womans University Seoul Hospital

    RECRUITING

    Seoul, Seoul-teukbyeolsi [seoul], 07804, South Korea

  • Fakultni nemocnice Olomouc

    RECRUITING

    Olomouc, 779 00, Czechia

  • Fakultní nemocnice Brno Bohunice

    RECRUITING

    Brno, Brno-město, 625 00, Czechia

  • Fondazione IRCCS San Gerardo dei Tintori

    RECRUITING

    Monza, Lombardy, 20900, Italy

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Grand Hôpital de Charleroi

    RECRUITING

    Gilly, Hainaut, 6060, Belgium

  • Gunma University Hospital

    RECRUITING

    Maebashi, Gunma, 371-8511, Japan

  • H.R.U Málaga - Hospital General

    RECRUITING

    Málaga, 29010, Spain

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, Jerusalem, 9112001, Israel

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

    RECRUITING

    Helsinki, 00029, Finland

  • Hospital Clínic de Barcelona

    RECRUITING

    Barcelona, Catalunya [cataluña], 08036, Spain

  • Hospital La Princesa

    RECRUITING

    Madrid, 28006, Spain

  • Hospital San Pedro de Alcántara

    RECRUITING

    Cáceres, 10003, Spain

  • Hospital Universitari Mutua Terrassa

    RECRUITING

    Terrassa, Barcelona [barcelona], 08221, Spain

  • Hospital Universitari i Politecnic La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital Universitario Doctor Peset

    RECRUITING

    Valencia, València, 46017, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario Marqués de Valdecilla

    RECRUITING

    Santander, Cantabria, 39008, Spain

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

    RECRUITING

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Hôpital Saint Antoine

    RECRUITING

    Paris, 75012, France

  • IRCCS Casa Sollievo della Sofferenza

    RECRUITING

    San Giovanni Rotondo, FG, 71013, Italy

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

    RECRUITING

    Meldola (Fc), Emilia-Romagna, 47014, Italy

  • Inselspital Bern

    NOT_YET_RECRUITING

    Bern, Canton of Bern, 3010, Switzerland

  • Institut Català d'Oncologia (ICO) - Badalona

    RECRUITING

    Badalona, Barcelona [barcelona], 08916, Spain

  • Institut Català d'Oncologia (ICO) - Girona

    RECRUITING

    Girona, Girona [gerona], 17007, Spain

  • Institut Català d'Oncologia - L'Hospitalet

    RECRUITING

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

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

    RECRUITING

    Toulouse, Haute-garonne, 31100, France

  • Institute of hematology&blood disease hospital

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Istituto Europeo di Oncologia IRCCS

    RECRUITING

    Milan, 20141, Italy

  • Iwate Medical University Hospital

    RECRUITING

    Yahaba-cho, Iwate, 028-3695, Japan

  • Japanese Red Cross Medical Center

    RECRUITING

    Shibuya-ku, Tokyo, 150-8935, Japan

  • Jupiter Medical Center/Anderson Family Cancer Institute

    RECRUITING

    Jupiter, Florida, 33458, United States

  • Kantonsspital Winterthur

    NOT_YET_RECRUITING

    Winterthur, 8401, Switzerland

  • Klinikum Chemnitz

    RECRUITING

    Chemnitz, 09116, Germany

  • Krankenhaus der Barmherzigen Schwestern Wien

    RECRUITING

    Vienna, State of Vienna, 1060, Austria

  • Kuopion Yliopistollinen Sairaala

    RECRUITING

    Kuopio, Northern Savonia, 70210, Finland

  • Kyushu University Hospital

    RECRUITING

    Fukuoka, 812-8582, Japan

  • Landeskrankenhaus Feldkirch

    RECRUITING

    Rankweil, Vorarlberg, 6830, Austria

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, England, LE1 5WW, United Kingdom

  • MSK Basking Ridge

    RECRUITING

    Basking Ridge, New Jersey, 07920, United States

  • MSK Bergen

    RECRUITING

    Montvale, New Jersey, 07645, United States

  • MSK Commack

    RECRUITING

    Commack, New York, 11725, United States

  • MSK Monmouth

    RECRUITING

    Middletown, New Jersey, 07748, United States

  • MSK Nassau

    RECRUITING

    Uniondale, New York, 11553, United States

  • MSK Westchester

    RECRUITING

    Harrison, New York, 10604, United States

  • Medizinische Universität Graz

    RECRUITING

    Graz, Styria, 8036, Austria

  • Medizinische Universität Wien

    RECRUITING

    Vienna, 1090, Austria

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

    RECRUITING

    New York, New York, 10021, United States

  • Memorial Sloan Kettering Cancer Center-Main Campus

    RECRUITING

    New York, New York, 10065, United States

  • Nanjing Drum Tower Hospital

    RECRUITING

    Nanjing, Jiangsu, 210008, China

  • National Hospital Organization Okayama Medical Center

    RECRUITING

    Okayama, 701-1192, Japan

  • National Taiwan University Hospital

    ACTIVE_NOT_RECRUITING

    Taipei, 10002, Taiwan

  • North Shore Hospital

    RECRUITING

    Auckland, 0622, New Zealand

  • Nova Scotia Health Authority

    RECRUITING

    Halifax, Nova Scotia, B3S 0H6, Canada

  • Osaka Metropolitan University Hospital

    RECRUITING

    Osaka, 545-0051, Japan

  • Ospedale Santa Maria delle Croci

    RECRUITING

    Ravenna, Emilia-Romagna, 48121, Italy

  • Oulu University Hospital

    RECRUITING

    Oulu, 90220, Finland

  • Peking University Third Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100091, China

  • Pindara Private Hospital

    RECRUITING

    Benowa, Queensland, 4217, Australia

  • Pratia Onkologia Katowice

    ACTIVE_NOT_RECRUITING

    Katowice, Silesian Voivodeship, 40-519, Poland

  • Princess Margaret Cancer Centre

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • QEII Health Sciences Centre

    RECRUITING

    Halifax, Nova Scotia, B3H 2Y9, Canada

  • Rabin Medical Center

    RECRUITING

    Petah Tikva, Central District, 4910021, Israel

  • Royal Stoke University Hospital

    RECRUITING

    Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

  • Samsung Medical Center

    RECRUITING

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

  • Seoul National University Bundang Hospital

    RECRUITING

    Seongnam, Kyǒnggi-do, 13620, South Korea

  • Seoul National University Hospital

    RECRUITING

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

  • Shizuoka Cancer Center

    RECRUITING

    Nagaizumi-cho, Shizuoka, 411-8777, Japan

  • Soroka Medical Center

    RECRUITING

    Beersheba, Southern District, 8410101, Israel

  • Sourasky Medical Center

    RECRUITING

    Tel Aviv, TELL ABĪB, 6423906, Israel

  • Southern Medical University Nanfang Hospital

    RECRUITING

    Guangzhou, Guangdong, 510515, China

  • St Vincent's Hospital Melbourne

    RECRUITING

    Fitzroy, Victoria, 3065, Australia

  • Städtisches Klinikum Braunschweig

    RECRUITING

    Braunschweig, 38114, Germany

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangzhou, Guangdong, 510555, China

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 407, Taiwan

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • The Beatson West of Scotland Cancer Centre

    NOT_YET_RECRUITING

    Glasgow, G12 0YN, United Kingdom

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

    RECRUITING

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

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

    RECRUITING

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

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

    RECRUITING

    Ramat Gan, Central District, 5265601, Israel

  • The First Affiliated Hospital of Soochow University

    RECRUITING

    Suzhou, Jiangsu, 215006, China

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • The first Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The first Affiliated hospital of Wenzhou medical University

    RECRUITING

    Wenzhou, Zhejiang, 325000, China

  • The first hospital of jilin university

    RECRUITING

    Changchun, Jilin, 130021, China

  • Tohoku University Hospital

    RECRUITING

    Sendai, Miyagi, 980-8574, Japan

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

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Tongji University - Shanghai Fourth People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200434, China

  • Turku University Hospital

    RECRUITING

    Turku, Southwest Finland, 20520, Finland

  • Uniklinikum Salzburg

    RECRUITING

    Salzburg, 5020, Austria

  • Universitaetsklinikum Tuebingen

    RECRUITING

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • Universitaetsklinikum Ulm

    RECRUITING

    Ulm, Baden-Wurttemberg, 89081, Germany

  • University Hospital of Ioannina

    RECRUITING

    Ioannina, Ípeiros, 455 00, Greece

  • University Hospital of Wales

    RECRUITING

    Cardiff, CF14 4XW, United Kingdom

  • University of Fukui Hospital

    RECRUITING

    Yoshida-gun, Fukui, 910-1193, Japan

  • Universitätsklinikum Aachen

    NOT_YET_RECRUITING

    Aachen, 52074, Germany

  • Universitätsklinikum St. Pölten

    RECRUITING

    Sankt Pölten, Lower Austria, 3100, Austria

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    RECRUITING

    Mainz, Rhineland-Palatinate, 55131, Germany

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

    RECRUITING

    Yvoir, Namur, 5530, Belgium

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

    ACTIVE_NOT_RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 50-367, Poland

  • Uniwersyteckie Centrum Kliniczne

    RECRUITING

    Gdansk, Pomeranian Voivodeship, 80-214, Poland

  • Vseobecna fakultni nemocnice v Praze

    RECRUITING

    Prague, 12808, Czechia

  • Waikato Hospital

    RECRUITING

    Hamilton, Waikato Region, 3204, New Zealand

  • Western General Hospital

    NOT_YET_RECRUITING

    Edinburgh, Midlothian, EH4 2XU, United Kingdom

  • Yamagata University Hospital

    RECRUITING

    Yamagata, 990-9585, Japan

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