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NCT05623020PHASE3Recruiting

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

Pfizer

Start Date

11/10/2022

Completion Date

10/3/2033

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 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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

Elranatamab

DRUG

Daratumumab

DRUG

Lenalidomide

DRUG

Dexamethasone

DRUG

Bortezomib

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Conditions

Multiple Myeloma

Locations

Jupiter Medical Center/Anderson Family Cancer Institute

Jupiter, Florida 33458

United States

MSK Basking Ridge

Basking Ridge, New Jersey 07920

United States

MSK Monmouth

Middletown, New Jersey 07748

United States

MSK Bergen

Montvale, New Jersey 07645

United States

MSK Commack

Commack, New York 11725

United States

MSK Westchester

Harrison, New York 10604

United States

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

New York, New York 10021

United States

Memorial Sloan Kettering Cancer Center-Main Campus

New York, New York 10065

United States

MSK Nassau

Uniondale, New York 11553

United States

The University of Texas MD Anderson Cancer Center

Houston, Texas 77030

United States

Pindara Private Hospital

Benowa, Queensland 4217

Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria 3065

Australia

Epworth Freemasons

Melbourne, Victoria 3002

Australia

The Alfred Hospital

Melbourne, Victoria 3004

Australia

Epworth Healthcare

Richmond, Victoria 3121

Australia

Medizinische Universität Graz

Graz, Styria 8036

Austria

Landeskrankenhaus Feldkirch

Rankweil, Vorarlberg 6830

Austria

Uniklinikum Salzburg

Salzburg, 5020

Austria

Medizinische Universität Wien

Vienna, 1090

Austria

Clinique Saint Pierre

Ottignies, Brabant Wallon 1340

Belgium

Grand Hôpital de Charleroi

Gilly, Hainaut 6060

Belgium

AZ Delta vzw

Roeselare, West-vlaanderen 8800

Belgium

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

Ribeirão Preto, São Paulo 14051-140

Brazil

Cross Cancer Institute

Edmonton, Alberta T6G 1Z2

Canada

Dr. Everett Chalmers Regional Hospital

Fredericton, New Brunswick E3B 5N5

Canada

QEII Health Sciences Centre

Halifax, Nova Scotia B3H 2Y9

Canada

Nova Scotia Health Authority

Halifax, Nova Scotia B3S 0H6

Canada

Princess Margaret Cancer Centre

Toronto, Ontario M5G 2M9

Canada

Peking University Third Hospital

Beijing, Beijing Municipality 100091

China

Fujian Medical University Union Hospital

Fuzhou, Fujian 350001

China

Southern Medical University Nanfang Hospital

Guangzhou, Guangdong 510515

China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong 510555

China

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

Wuhan, Hubei 430030

China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu 210008

China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu 215006

China

The first hospital of jilin university

Changchun, Jilin 130021

China

Tongji University - Shanghai Fourth People's Hospital

Shanghai, Shanghai Municipality 200434

China

Institute of hematology&blood disease hospital

Tianjin, Tianjin Municipality 300020

China

The first Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang 310003

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 Olomouc

Olomouc, 779 00

Czechia

Vseobecna fakultni nemocnice v Praze

Prague, 12808

Czechia

Kuopion Yliopistollinen Sairaala

Kuopio, Northern Savonia 70210

Finland

Turku University Hospital

Turku, Southwest Finland 20520

Finland

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

Helsinki, 00029

Finland

Oulu University Hospital

Oulu, 90220

Finland

Centre Hospitalier Universitaire de Nice - Hôpital l'Archet

Nice, Alpes-maritimes 06200

France

Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE

Toulouse, Haute-garonne 31100

France

Centre Hospitalier Universitaire de Poitiers

Poitiers, Vienne 86021

France

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

Nantes, 44093 Cedex 1

France

Hôpital Saint Antoine

Paris, 75012

France

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg 72076

Germany

Universitaetsklinikum Ulm

Ulm, Baden-Wurttemberg 89081

Germany

Universitätsmedizin Johannes Gutenberg Universität Mainz

Mainz, Rhineland-Palatinate 55131

Germany

Städtisches Klinikum Braunschweig

Braunschweig, 38114

Germany

Klinikum Chemnitz

Chemnitz, 09116

Germany

Evangelismos General Hospital of Athens

Athens, Attikí 106 76

Greece

Alexandra General Hospital of Athens

Athens, Attikí 115 28

Greece

"Theagenio" Cancer Hospital of Thessaloniki

Thessaloniki, Kentrikí Makedonía 540 07

Greece

Evangelismos General Hospital of Athens

Athens, 10676

Greece

University Hospital of Ioannina

Ioannina, Ípeiros 455 00

Greece

Rabin Medical Center

Petah Tikva, Central District 4910021

Israel

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

Ramat Gan, Central District 5265601

Israel

Hadassah Medical Center

Jerusalem, Jerusalem 9112001

Israel

Soroka Medical Center

Beersheba, Southern District 8410101

Israel

Sourasky Medical Center

Tel Aviv, TELL ABĪB 6423906

Israel

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

Meldola (Fc), Emilia-Romagna 47014

Italy

AUSL di Piacenza

Piacenza, Emilia-Romagna 29121

Italy

Ospedale Santa Maria delle Croci

Ravenna, Emilia-Romagna 48121

Italy

IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, FG 71013

Italy

Cro-Irccs

Aviano, Friuli Venezia Giulia 33081

Italy

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy 20900

Italy

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

Turin, Piedmont 10126

Italy

A.O.U. Policlinico Paolo Giaccone

Palermo, Sicily 90127

Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Tuscany 56126

Italy

Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII

Bergamo, 24127

Italy

Istituto Europeo di Oncologia IRCCS

Milan, 20141

Italy

ASL PESCARA-Presidio Ospedaliero Pescara

Pescara, 65124

Italy

Azienda Sanitaria Locale di Pescara

Pescara, 65124

Italy

AOU Policlinico Umberto I

Roma, 00161

Italy

University of Fukui Hospital

Yoshida-gun, Fukui 910-1193

Japan

Gunma University Hospital

Maebashi, Gunma 371-8511

Japan

Iwate Medical University Hospital

Yahaba-cho, Iwate 028-3695

Japan

Tohoku University Hospital

Sendai, Miyagi 980-8574

Japan

Shizuoka Cancer Center

Nagaizumi-cho, Shizuoka 411-8777

Japan

Japanese Red Cross Medical Center

Shibuya-ku, Tokyo 150-8935

Japan

Kyushu University Hospital

Fukuoka, 812-8582

Japan

National Hospital Organization Okayama Medical Center

Okayama, 701-1192

Japan

Osaka Metropolitan University Hospital

Osaka, 545-0051

Japan

Yamagata University Hospital

Yamagata, 990-9585

Japan

Albert Schweitzer Ziekenhuis, locatie Dordwijk

Dordrecht, South Holland 3318 AT

Netherlands

Auckland City Hospital

Grafton, Auckland 1023

New Zealand

Waikato Hospital

Hamilton, Waikato Region 3204

New Zealand

North Shore Hospital

Auckland, 0622

New Zealand

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu

Wroclaw, Lower Silesian Voivodeship 50-367

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship 80-214

Poland

Pratia Onkologia Katowice

Katowice, Silesian Voivodeship 40-519

Poland

Auxilio Mutuo Cancer Center

San Juan, 00917

Puerto Rico

Chonnam National University Hwasun Hospital

Hwasun-gun, Jeonranamdo 58128

South Korea

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do 13620

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 St. Mary's Hospital)

Seoul, Seoul-teukbyeolsi [seoul] 06591

South Korea

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

Seoul, Seoul-teukbyeolsi [seoul] 06591

South Korea

CHUS - Hospital Clinico Universitario

Santiago de Compostela, A Coruña [LA Coruña] 15706

Spain

Institut Català d'Oncologia (ICO) - Badalona

Badalona, Barcelona [barcelona] 08916

Spain

Institut Català d'Oncologia - L'Hospitalet

L'Hospitalet Del Llobregat, Barcelona [barcelona] 08908

Spain

Hospital Universitari Mutua Terrassa

Terrassa, Barcelona [barcelona] 08221

Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria 39008

Spain

Hospital Clínic de Barcelona

Barcelona, Catalunya [cataluña] 08036

Spain

Institut Català d'Oncologia (ICO) - Girona

Girona, Girona [gerona] 17007

Spain

Clinica Universidad de Navarra

Madrid, Madrid, Comunidad de 28027

Spain

Clinica Universidad de Navarra

Pamplona, Navarre 31008

Spain

Hospital Universitario Doctor Peset

Valencia, València 46017

Spain

Hospital San Pedro de Alcántara

Cáceres, 10003

Spain

Hospital La Princesa

Madrid, 28006

Spain

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040

Spain

H.R.U Málaga - Hospital General

Málaga, 29010

Spain

Hospital Universitari i Politecnic La Fe

Valencia, 46026

Spain

Kantonsspital Winterthur

Winterthur, 8401

Switzerland

China Medical University Hospital

Taichung, 404332

Taiwan

Taichung Veterans General Hospital

Taichung, 407

Taiwan

National Taiwan University Hospital

Taipei, 10002

Taiwan

Chang Gung Medical Foundation-Linkou Branch

Taoyuan, 333

Taiwan

Leicester Royal Infirmary

Leicester, England LE1 5WW

United Kingdom

University Hospital of Wales

Cardiff, CF14 4XW

United Kingdom