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RECRUITING

NCT05623020

PHASE3

A Study to Learn About Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant or Who Will Not Receive a Transplant as Initial Therapy

Sponsor: Pfizer

View on ClinicalTrials.gov

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, 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 minimal residual disease (MRD) negativity rate and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.

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 + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE OR TRANSPLANT-DEFERRED PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1116

Start Date

2022-11-10

Completion Date

2033-10-03

Last Updated

2026-03-20

Healthy Volunteers

Conditions

Multiple Myeloma

Interventions

DRUG

Elranatamab

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

DRUG

Daratumumab

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

DRUG

Lenalidomide

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

DRUG

Dexamethasone

Randomized

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; * 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 by age or comorbidities impacting the possibility of transplant) or * transplant deferred (defined as clinically transplant-eligible but who does not intend to receive transplant as a first line of therapy). * 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.

Locations (88)

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

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 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

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

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Klinikum Chemnitz

Chemnitz, 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

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

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

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

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 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

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 District, Taiwan

Clinical Research Directory

A Study to Learn About Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant or Who Will Not Receive a Transplant as Initial Therapy

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (88)