Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant | NCT05317416 | Trialant

Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant | NCT05317416 | Trialant

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Eligibility Criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

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)

Banner Gateway Medical Center

Gilbert, Arizona 85234, United States

Banner Gateway Medical Pavilion

Gilbert, Arizona 85234, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona 85234, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California 90095, United States

UCLA Department of Medicine - Hematology/Oncology

Los Angeles, California 90095, United States

UCLA Hematology/Oncology

Los Angeles, California 90095, United States

Santa Monica UCLA Medical Center & Orthopaedic Hospital

Santa Monica, California 90404, United States

UCLA Hematology/Oncology - Santa Monica

Santa Monica, California 90404, United States

Georgetown University Medical Center

Washington D.C., District of Columbia 20007, United States

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida 33176, United States

Winship Cancer Institute, Emory University

Atlanta, Georgia 30322, United States

Loyola University Chicago

Maywood, Illinois 60153, United States

Ascentist Doctor Hospital

Leawood, Kansas 66211, United States

University of Michigan

Ann Arbor, Michigan 48109, United States

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

Kansas City, Missouri 64132, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire 03756, United States

WMCHealth Advanced Physician Services

Hawthorne, New York 10532, United States

Westchester Medical Center

Valhalla, New York 10595, United States

Cleveland Clinic

Cleveland, Ohio 44195, United States

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

Columbus, Ohio 43214, United States

OhioHealth Research Institute

Columbus, Ohio 43214, United States

OhioHealth Riverside Methodist Hospital

Columbus, Ohio 43214, United States

Baylor University Medical Center

Dallas, Texas 75246, United States

Baylor Scott & White Medical Center - Temple

Temple, Texas 76508, United States

Royal Prince Alfred Hospital

Camperdown, New South Wales 2050, Australia

Shoalhaven District Memorial Hospital

Nowra, New South Wales 2541, Australia

Westmead Hospital

Westmead, New South Wales 2145, Australia

Wollongong Hospital

Wollongong, New South Wales 2500, Australia

Pindara Private Hospital

Benowa, Queensland 4217, Australia

QScan Radiology Clinics

Clayfield, Queensland 4011, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland 4102, Australia

Epworth Healthcare

East Melbourne, Victoria 3002, Australia

Precision Haematology

East Melbourne, Victoria 3002, Australia

St Vincent's Hospital (Melbourne)

Fitzroy, Victoria 3065, Australia

Slade Pharmacy

Richmond, 3121, Australia

Medizinische Universität Wien

Vienna, 1090, Austria

Institut Jules Bordet

Anderlecht, Bruxelles-capitale, Région de 1070, Belgium

Grand Hôpital de Charleroi

Charleroi, Hainaut 6060, Belgium

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

Yvoir, Namur 5530, Belgium

UZ Gent

Ghent, Oost-vlaanderen 9000, Belgium

ZNA Middelheim

Antwerp, 2020, Belgium

ZNA Cadix

Antwerp, 2030, Belgium

UZ Brussel

Brussels, 1090, Belgium

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

Salvador, Estado de Bahia 41253-190, Brazil

Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa

Porto Alegre, Rio Grande do Sul 90110-270, Brazil

Centro de Pesquisa Clínica - Área Administrativa

Porto Alegre, Rio Grande do Sul 90850-170, Brazil

Hospital Mae de Deus

Porto Alegre, Rio Grande do Sul 90880-480, Brazil

Hospital Amaral Carvalho

Jaú, São Paulo 17210-080, Brazil

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

Ribeirão Preto, São Paulo 14051-140, Brazil

BP - A Beneficencia Portuguesa de São Paulo

São Paulo, São Paulo 01321-001, Brazil

Clínica Médica São Germano LTDA

SP, São Paulo 04537-080, Brazil

Américas Medical City

Rio de Janeiro, 22775-001, Brazil

Instituto de Educação, Pesquisa e Gestão em Saúde

Rio de Janeiro, 22775001, Brazil

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

São Paulo, 01232-010, Brazil

HU UNIFESP / SPDM - Hospital São Paulo

São Paulo, 04024-002, Brazil

Universidade Federal de Sao Paulo

São Paulo, 04024-002, Brazil

Hospital Japonês Santa Cruz

São Paulo, 04122-000, Brazil

Clínica Médica São Germano S/S Ltda

São Paulo, 04537-080, Brazil

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta T2N 5G2, Canada

Dr. Everett Chalmers Regional Hospital

Fredericton, New Brunswick E3B 5N5, Canada

Saint John Regional Hospital

Saint John, New Brunswick E2L 4L2, Canada

Hamilton Health Sciences Corporation

Hamilton, Ontario L8L 8E7, Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9, Canada

Windsor Regional Hospital Cancer Program

Windsor, Ontario N8W 1L9, Canada

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

Montreal, Quebec H1T 2M4, Canada

McGill University Health Centre

Montreal, Quebec H4A 3J1, Canada

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

Montreal, Quebec H4J 1C5, Canada

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong 510555, China

Institute of hematology&blood disease hospital

Tianjin, Tianjin Municipality 300020, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang 325000, China

Fakultní nemocnice Brno Bohunice

Brno, Brno-město 625 00, Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, Hradec Králové 500 05, Czechia

Fakultni nemocnice Ostrava

Ostrava, Moravian-Silesian Region 708 52, Czechia

Fakultni nemocnice Olomouc

Olomouc, 779 00, Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 12808, Czechia

Turku University Hospital

Turku, Southwest Finland 20520, Finland

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

Helsinki, Uusimaa 00029, Finland

Oulun yliopistollinen sairaala

Oulu, 90220, Finland

Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

Toulouse, Haute-garonne 31100, France

Pitie Salpetriere University Hospital

Paris, ORNE 75013, France

Gustave Roussy

Villejuif, Val-de-marne 94800, France

Centre Hospitalier Universitaire de Poitiers

Poitiers, Vienne 86021, France

Hopital Claude Huriez - CHU de Lille

Lille, 59037, France

Hôpital Saint Antoine

Paris, 75571, France

Hopital Lyon Sud

Pierre-Bénite, 69495, France

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau

Tours, 37032, France

Universitätsklinikum Würzburg

Würzburg, Bavaria 97080, Germany

Universitätsmedizin Johannes Gutenberg Universität Mainz

Mainz, Rhineland-Palatinate 55131, Germany

Universitätsklinikum Leipzig

Leipzig, Saxony 04103, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein 24105, Germany

Charite Universitätsmedizin Berlin Campus Benjamin Franklin

Berlin, 12200, Germany

Klinikum Chemnitz gGMbH

Chemnitz, 09116, Germany

Universitätsklinikum Essen

Essen, 45147, Germany

Klinikum rechts der Isar der Technischen Universität München

München, 81675, Germany

Alexandra General Hospital of Athens

Athens, Attikí 115 28, Greece

Theageneio Cancer Hospital of Thessaloniki

Thessaloniki, Kentrikí Makedonía 546 39, Greece

University Hospital of Ioannina

Ioannina, Ípeiros 455 00, Greece

Somogy Megyei Kaposi Mór Oktató Kórház

Kaposvár, Somogy County 7400, Hungary

Semmelweis University

Budapest, 1088, Hungary

Dél-Pesti Centrumkórház

Budapest, 1097, Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

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

Nyíregyháza, 4400, Hungary

Artemis hospital

Gurugram, Haryana 122001, India

Medanta-The Medicity

Gurugram, Haryana 122001, India

Fortis Memorial Research Institute

Gurugram, Haryana 122002, India

Himalayan Institute Hospital Trust University

Dehradun, Uttarakhand 248140, India

Tata Medical Center

Kolkata, West Bengal 700160, India

Rajiv Gandhi Cancer Institute And Research Centre

Delhi, 110085, India

Rabin Medical Center

Petah Tikva, Central District 4910021, Israel

Sheba Medical Center

Ramat Gan, Central District 5262100, Israel

Shaare Zedek Medical Center

Jerusalem, Jerusalem 9013102, Israel

Hadassah Medical Center

Jerusalem, Jerusalem 9112001, Israel

Hadassah Mount Scopus Medical Center

Jerusalem, Jerusalem 9124001, Israel

Rambam Health Care Campus

Haifa, Northern District 3109601, Israel

Soroka Medical Center

Beersheba, Southern District 8410101, Israel

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

Tel Aviv, TELL ABĪB 6423906, Israel

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

Meldola, Emilia-Romagna 47014, Italy

Fondazione Policlinico Universitario Agostino Gemelli

Rome, Lazio 00168, Italy

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico

Milan, Lombardy 20122, Italy

Policlinico "G. Rodolico"

Catania, Sicily 95123, Italy

Azienda Ospedaliero Universitaria Senese

Siena, Tuscany 53100, Italy

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

Ancona, 60126, Italy

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

Bologna, 40138, Italy

AOU Policlinico Umberto I

Roma, 00161, Italy

Nagoya City University Hospital

Nagoya, Aichi-ken 467-8602, Japan

Gunma University Hospital

Maebashi, Gunma 371-8511, Japan

Kobe City Medical Center General Hospital

Kobe, Hyōgo 650-0047, Japan

Iwate Medical University Hospital

Yahaba-cho, Iwate 028-3695, Japan

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, Kyoto 602-8566, Japan

Tohoku University Hospital

Sendai, Miyagi 980-8574, Japan

Hamamatsu University Hospital

Hamamatsu, Shizuoka 431-3192, Japan

Shizuoka Cancer Center

Sunto-gun, Shizuoka 411-8777, Japan

Nippon Medical School Hospital

Bunkyo-ku, Tokyo 113-8603, Japan

Yamagata University Hospital

Yamagata, Yamagata 990-9585, Japan

National Hospital Organization Kumamoto Medical Center

Kumamoto, 860-0008, Japan

University Hospital,Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

National Hospital Organization Okayama Medical Center

Okayama, 701-1192, Japan

Osaka Metropolitan University Hospital

Osaka, 545-8586, Japan

Japanese Red Cross Medical Center

Tokyo, 150-8935, Japan

HagaZiekenhuis

The Hague, South Holland 2545 AA, Netherlands

Maastricht Universitair Medisch Centrum

Maastricht, 6229 HX, Netherlands

Isala

Zwolle, 8025 AB, Netherlands

Oslo Universitetssykehus Ullevål

Oslo, 0450, Norway

Stavanger Universitetssykehus

Stavanger, 4011, Norway

Centrum Medyczne Pratia Poznań

Skórzewo, Greater Poland Voivodeship 60-185, Poland

Pratia Onkologia Katowice

Katowice, Silesian Voivodeship 40-519, Poland

Uniwersyteckie Centrum Kliniczne,

Gdansk, 80-214, Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, 60-569, Poland

Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny

Warsaw, 02-097, Poland

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

Warsaw, 02-781, Poland

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

Wroclaw, 50-367, Poland

Gachon University Gil Medical Center

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

Chonnam National University Hwasun Hospital

Hwasun Gun, Jeonranamdo 58128, South Korea

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do 13620, South Korea

Pusan National University Hospital

Busan, Pusan-kwangyǒkshi 49241, South Korea

Seoul National University Hospital

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

Samsung Medical Center

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

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

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

Kyungpook National University

Daegu, Taegu-kwangyǒkshi 41944, South Korea

Kyungpook National University Hospital

Junggu, Taegu-kwangyǒkshi 41944, South Korea

Complejo Hospitalario Universitario de Santiago

Santiago de Compostela, A Coruna 15706, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona [barcelona] 08035, Spain

Institut Català d'Oncologia - L'Hospitalet

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

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona [barcelona] 08221, Spain

Institut Catala d' Oncologia. Hospital Germans Trias i Pujol

Badalona, Barcelona 08916, Spain

Hospital Universitario de Salamanca

Salamanca, Castille and León 37007, Spain

Hospital Clínic de Barcelona

Barcelona, Catalunya [cataluña] 08036, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid 28223, Spain

Clinica Universidad de Navarra

Madrid, Madrid, Comunidad de 28027, Spain

Hospital Universitario La Paz

Madrid, Madrid, Comunidad de 28046, Spain

Hospital San Pedro de Alcántara

Cáceres, 10003, Spain

Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta

Girona, 17007, Spain

Hospital La Princesa

Madrid, 28006, Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Hospital Universitario HM Sanchinarro

Madrid, 28050, Spain

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Helsingborgs Lasarett

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

Karolinska Universitetssjukhuset Huddinge

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

Södra Älvsborgs Sjukhus Borås

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

Falu Lasarett

Falun, 791 31, Sweden

Universitetssjukhuset Örebro

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

Universitetssjukhuset i Linköping

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

Inselspital Bern

Bern, Canton of Bern 3010, Switzerland

CHUV (centre hospitalier universitaire vaudois)

Lausanne, Canton of Vaud 1011, Switzerland

UniversitätsSpital Zürich

Zurich, Zürich (DE) 8091, Switzerland

Kantonsspital Baden

Baden, 5404, Switzerland

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

China Medical University Hospital

Taichung, 40447, Taiwan

Taichung Veterans General Hospital

Taichung, 407, Taiwan

National Taiwan University Hospital

Taipei, 10002, Taiwan

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333, Taiwan

Medipol Mega Universite Hastanesi

Istanbul, İ̇stanbul 34214, Turkey (Türkiye)

Sisli Florence Nightingale Hastanesi

Istanbul, İ̇stanbul 34381, Turkey (Türkiye)

Ege Universitesi Hastanesi

Izmir, İ̇zmir 35100, Turkey (Türkiye)

Dokuz Eylul Universitesi Hastanesi

Izmir, İ̇zmir 35340, Turkey (Türkiye)

Ankara University Health Practice and Research Hospitals

Ankara, 06100, Turkey (Türkiye)

Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi

Ankara, 06200, Turkey (Türkiye)

Aydın Adnan Menderes Universitesi Hastanesi

Aydin, 09100, Turkey (Türkiye)

Erciyes Universitesi Tıp Fakultesi Hastaneleri

Kayseri, 38030, Turkey (Türkiye)

Özel Anadolu Sağlık Merkezi

Kocaeli, 41400, Turkey (Türkiye)

Addenbrooke's Hospital

Cambridge, Cambridgeshire CB2 2QQ, United Kingdom

Queen Elizabeth Hospital Birmingham

Birmingham, England B15 2TH, United Kingdom

Belfast City Hospital

Belfast, BT9 7AB, United Kingdom

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YN, United Kingdom

Royal Berkshire Hospital

Reading, RG1 5AN, United Kingdom

New Cross Hospital

Wolverhampton, WV10 0QP, United Kingdom