A RANDOMIZED, 2-ARM, PHASE 3 STUDY OF ELRANATAMAB (PF-06863135) VERSUS LENALIDOMIDE IN PATIENTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA AFTER UNDERGOING AUTOLOGOUS STEM-CELL TRANSPLANTATION

Status: Recruiting
Location: See all (216) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Banner Gateway Medical Center
RECRUITING
Gilbert
Banner Gateway Medical Pavilion
RECRUITING
Gilbert
Banner MD Anderson Cancer Center
RECRUITING
Gilbert
California
Ronald Reagan UCLA Medical Center
RECRUITING
Los Angeles
UCLA Department of Medicine - Hematology/Oncology
RECRUITING
Los Angeles
UCLA Hematology/Oncology
RECRUITING
Los Angeles
UCLA Hematology/Oncology - Santa Monica
RECRUITING
Los Angeles
Santa Monica UCLA Medical Center & Orthopaedic Hospital
RECRUITING
Santa Monica
Washington, D.c.
Georgetown University Medical Center
RECRUITING
Washington D.c.
Florida
Miami Cancer Institute at Baptist Health, Inc.
RECRUITING
Miami
Georgia
Emory University Hospital
RECRUITING
Atlanta
Emory University Hospital Midtown
RECRUITING
Atlanta
Investigational Drug Service, Emory University Clinic
RECRUITING
Atlanta
Winship Cancer Institute, Emory University
RECRUITING
Atlanta
Illinois
Loyola University Chicago
RECRUITING
Maywood
Kansas
Ascentist Doctor Hospital
RECRUITING
Leawood
American Oncology Partners, P.A. dba MidAmerica Cancer Care
RECRUITING
Merriam
O'Brien Pharmacy
RECRUITING
Mission
Michigan
University of Michigan
RECRUITING
Ann Arbor
Missouri
American Oncology Partners, P.A. Dba MidAmerica Cancer Care
RECRUITING
Kansas City
New Hampshire
Dartmouth-Hitchcock Medical Center
RECRUITING
Lebanon
New York
WMCHealth Advanced Physician Services
RECRUITING
Hawthorne
Westchester Medical Center
RECRUITING
Valhalla
Ohio
Cleveland Clinic
RECRUITING
Cleveland
OhioHealth Arthur G.H. Bing, MD, Cancer Center
RECRUITING
Columbus
OhioHealth Research Institute
RECRUITING
Columbus
OhioHealth Riverside Methodist Hospital
RECRUITING
Columbus
Texas
Baylor University Medical Center
RECRUITING
Dallas
Baylor Scott & White Medical Center - Temple
RECRUITING
Temple
Other Locations
Australia
Pindara Private Hospital
RECRUITING
Benowa
Royal Prince Alfred Hospital
RECRUITING
Camperdown
QScan Radiology Clinics
RECRUITING
Clayfield
Epworth Healthcare
RECRUITING
East Melbourne
Precision Haematology
RECRUITING
East Melbourne
St Vincent's Hospital (Melbourne)
RECRUITING
Fitzroy
Shoalhaven District Memorial Hospital
RECRUITING
Nowra
Slade Pharmacy
RECRUITING
Richmond
Westmead Hospital
RECRUITING
Westmead
Wollongong Hospital
RECRUITING
Wollongong
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Hanusch-Krankenhaus
RECRUITING
Vienna
Medizinische Universität Wien
RECRUITING
Vienna
Medizinische Universität Wien
RECRUITING
Vienna
Belgium
Institut Jules Bordet
RECRUITING
Anderlecht
Zna Cadix
RECRUITING
Antwerp
ZNA Middelheim
RECRUITING
Antwerp
UZ Brussel
RECRUITING
Brussels
Grand Hôpital de Charleroi
RECRUITING
Charleroi
UZ Gent
RECRUITING
Ghent
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
RECRUITING
Yvoir
Brazil
Fundação Doutor Amaral Carvalho
RECRUITING
Jaú
Hospital Amaral Carvalho
RECRUITING
Jaú
Centro de Pesquisa Clínica - Área Administrativa
RECRUITING
Porto Alegre
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
RECRUITING
Porto Alegre
Hospital Mae de Deus
RECRUITING
Porto Alegre
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP)
RECRUITING
Ribeirão Preto
Américas Medical City
RECRUITING
Rio De Janeiro
Instituto de Educação, Pesquisa e Gestão em Saúde
RECRUITING
Rio De Janeiro
Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial Salvador
RECRUITING
Salvador
BP - A Beneficencia Portuguesa de São Paulo
ACTIVE_NOT_RECRUITING
São Paulo
Clínica Médica São Germano S/S Ltda
RECRUITING
São Paulo
ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis
RECRUITING
São Paulo
Hospital Japonês Santa Cruz
TERMINATED
São Paulo
HU UNIFESP / SPDM - Hospital São Paulo
RECRUITING
São Paulo
Universidade Federal de Sao Paulo
RECRUITING
São Paulo
Clínica Médica São Germano LTDA
RECRUITING
Sp
Canada
Arthur J.E. Child Comprehensive Cancer Centre
RECRUITING
Calgary
Dr. Everett Chalmers Regional Hospital
RECRUITING
Fredericton
Hamilton Health Sciences Corporation
RECRUITING
Hamilton
Centre Integre Universitaire de la Santé et de Services Sociaux de l'Est-de-l'ile-de-Montreal,
RECRUITING
Montreal
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎ
RECRUITING
Montreal
McGill University Health Centre
RECRUITING
Montreal
Saint John Regional Hospital
RECRUITING
Saint John
Princess Margaret Cancer Centre
RECRUITING
Toronto
Windsor Regional Hospital Cancer Program
RECRUITING
Windsor
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Institute of hematology&blood disease hospital
RECRUITING
Tianjin
The First Affiliated Hospital of Wenzhou Medical University
RECRUITING
Wenzhou
Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
RECRUITING
Helsinki
Oulun yliopistollinen sairaala
RECRUITING
Oulu
Turku University Hospital
RECRUITING
Turku
France
Chu Grenoble Alpes
NOT_YET_RECRUITING
La Tronche
Hopital Claude Huriez - CHU de Lille
RECRUITING
Lille
Hôpital Saint Antoine
RECRUITING
Paris
Pitie Salpetriere University Hospital
RECRUITING
Paris
Hopital Lyon Sud
RECRUITING
Pierre-bénite
Centre Hospitalier Universitaire de Poitiers
RECRUITING
Poitiers
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
RECRUITING
Toulouse
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
RECRUITING
Tours
Gustave Roussy
RECRUITING
Villejuif
Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin
RECRUITING
Berlin
Klinikum Chemnitz gGMbH
RECRUITING
Chemnitz
Universitätsklinikum Essen
RECRUITING
Essen
Universitaetsklinikum Schleswig-Holstein Campus Kiel
ACTIVE_NOT_RECRUITING
Kiel
Universitätsklinikum Leipzig
RECRUITING
Leipzig
Universitätsmedizin Johannes Gutenberg Universität Mainz
RECRUITING
Mainz
Klinikum rechts der Isar der Technischen Universität München
RECRUITING
München
Universitätsklinikum Würzburg
RECRUITING
Würzburg
Greece
Alexandra General Hospital of Athens
RECRUITING
Athens
University Hospital of Ioannina
RECRUITING
Ioannina
Theageneio Cancer Hospital of Thessaloniki
RECRUITING
Thessaloniki
Hungary
Dél-Pesti Centrumkórház
ACTIVE_NOT_RECRUITING
Budapest
Semmelweis University
ACTIVE_NOT_RECRUITING
Budapest
Debreceni Egyetem Klinikai Kozpont
TERMINATED
Debrecen
Somogy Megyei Kaposi Mór Oktató Kórház
ACTIVE_NOT_RECRUITING
Kaposvár
Szabolcs-Szatmár-Bereg Megyei Kórházak és Egyetemi Oktatókórház, Jósa András Oktatókórház
ACTIVE_NOT_RECRUITING
Nyíregyháza
India
Himalayan Institute Hospital Trust University
ACTIVE_NOT_RECRUITING
Dehradun
Rajiv Gandhi Cancer Institute And Research Centre
TERMINATED
Delhi
Artemis hospital
TERMINATED
Gurugram
Fortis Memorial Research Institute
TERMINATED
Gurugram
Medanta-The Medicity
ACTIVE_NOT_RECRUITING
Gurugram
Tata Medical Center
ACTIVE_NOT_RECRUITING
Kolkata
Israel
Soroka Medical Center
RECRUITING
Beersheba
Rambam Health Care Campus
RECRUITING
Haifa
Hadassah Medical Center
RECRUITING
Jerusalem
Hadassah Mount Scopus Medical Center
RECRUITING
Jerusalem
Shaare Zedek Medical Center
ACTIVE_NOT_RECRUITING
Jerusalem
Shaare Zedek Medical Center
ACTIVE_NOT_RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Tel-Aviv Sourasky Medical Center Dana-Dwek Children's Hospital
RECRUITING
Tel Aviv
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi
RECRUITING
Ancona
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
RECRUITING
Bologna
Policlinico G. Rodolico
RECRUITING
Catania
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
RECRUITING
Meldola
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
RECRUITING
Milan
AOU Policlinico Umberto I
RECRUITING
Roma
Fondazione Policlinico Universitario Agostino Gemelli
RECRUITING
Rome
Azienda Ospedaliero Universitaria Senese
RECRUITING
Siena
Japan
Nippon Medical School Hospital
RECRUITING
Bunkyo-ku
Hamamatsu University Hospital
RECRUITING
Hamamatsu
Kagoshima University Hospital
RECRUITING
Kagoshima
Kobe City Medical Center General Hospital
RECRUITING
Kobe
National Hospital Organization Kumamoto Medical Center
RECRUITING
Kumamoto
University Hospital,Kyoto Prefectural University of Medicine
RECRUITING
Kyoto
University Hospital,Kyoto Prefectural University of Medicine
RECRUITING
Kyoto
Gunma University Hospital
RECRUITING
Maebashi
Nagoya City University Hospital
RECRUITING
Nagoya
National Hospital Organization Okayama Medical Center
RECRUITING
Okayama
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Tohoku University Hospital
RECRUITING
Sendai
Shizuoka Cancer Center
RECRUITING
Sunto-gun
Japanese Red Cross Medical Center
RECRUITING
Tokyo
Iwate Medical University Hospital
RECRUITING
Yahaba-cho
Yamagata University Hospital
RECRUITING
Yamagata
Netherlands
Maastricht Universitair Medisch Centrum
RECRUITING
Maastricht
HagaZiekenhuis
RECRUITING
The Hague
Isala
RECRUITING
Zwolle
Norway
Oslo Universitetssykehus Ullevål
RECRUITING
Oslo
Stavanger Universitetssykehus
RECRUITING
Stavanger
Poland
Uniwersyteckie Centrum Kliniczne,
ACTIVE_NOT_RECRUITING
Gdansk
Pratia Onkologia Katowice
ACTIVE_NOT_RECRUITING
Katowice
Uniwersytecki Szpital Kliniczny w Poznaniu
ACTIVE_NOT_RECRUITING
Poznan
Centrum Medyczne Pratia Poznań
ACTIVE_NOT_RECRUITING
Skórzewo
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy
ACTIVE_NOT_RECRUITING
Warsaw
Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital Kliniczny
ACTIVE_NOT_RECRUITING
Warsaw
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
ACTIVE_NOT_RECRUITING
Wroclaw
Republic of Korea
Pusan National University Hospital
TERMINATED
Busan
Kyungpook National University
TERMINATED
Daegu
Chonnam National University Hwasun Hospital
ACTIVE_NOT_RECRUITING
Hwasun Gun
Kyungpook National University Hospital
TERMINATED
Junggu
Gachon University Gil Medical Center
ACTIVE_NOT_RECRUITING
Namdong-gu
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Samsung Medical Center
ACTIVE_NOT_RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
The Catholic Univ. of Korea Seoul St. Mary's Hospital
ACTIVE_NOT_RECRUITING
Seoul
The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)
ACTIVE_NOT_RECRUITING
Seoul
Spain
Institut Catala d' Oncologia. Hospital Germans Trias i Pujol
RECRUITING
Badalona
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron
RECRUITING
Barcelona
Hospital San Pedro de Alcántara
RECRUITING
Cáceres
Institut Catala Oncologia - Hospital Universitari de Girona Dr Josep Trueta
RECRUITING
Girona
Institut Català d'Oncologia - L'Hospitalet
RECRUITING
L'hospitalet Del Llobregat
Clinica Universidad de Navarra
RECRUITING
Madrid
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital La Princesa
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Hospital Universitario La Paz
RECRUITING
Madrid
Hospital Universitario Quironsalud Madrid
RECRUITING
Pozuelo De Alarcón
Hospital Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
RECRUITING
Salamanca
Complejo Hospitalario Universitario de Santiago
RECRUITING
Santiago De Compostela
Hospital Universitari Mutua Terrassa
RECRUITING
Terrassa
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Sweden
Södra Älvsborgs Sjukhus Borås
RECRUITING
Borås
Falu Lasarett
RECRUITING
Falun
Helsingborgs Lasarett
RECRUITING
Helsingborg
Universitetssjukhuset i Linköping
RECRUITING
Linköping
Universitetssjukhuset Örebro
RECRUITING
Örebro
Karolinska Universitetssjukhuset Huddinge
RECRUITING
Stockholm
Switzerland
Kantonsspital Baden
RECRUITING
Baden
Inselspital Bern
RECRUITING
Bern
CHUV (centre hospitalier universitaire vaudois)
RECRUITING
Lausanne
Kantonsspital Winterthur
RECRUITING
Winterthur
UniversitätsSpital Zürich
RECRUITING
Zurich
Taiwan
China Medical University Hospital
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
National Taiwan University Hospital
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch
RECRUITING
Taoyuan District
Turkey
Ankara University Health Practice and Research Hospitals
ACTIVE_NOT_RECRUITING
Ankara
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
ACTIVE_NOT_RECRUITING
Ankara
Aydın Adnan Menderes Universitesi Hastanesi
ACTIVE_NOT_RECRUITING
Aydin
Medipol Mega Universite Hastanesi
ACTIVE_NOT_RECRUITING
Istanbul
Sisli Florence Nightingale Hastanesi
TERMINATED
Istanbul
Dokuz Eylul Universitesi Hastanesi
ACTIVE_NOT_RECRUITING
Izmir
Ege Universitesi Hastanesi
ACTIVE_NOT_RECRUITING
Izmir
Erciyes Universitesi Tıp Fakultesi Hastaneleri
TERMINATED
Kayseri
Özel Anadolu Sağlık Merkezi
ACTIVE_NOT_RECRUITING
Kocaeli
United Kingdom
Belfast City Hospital
RECRUITING
Belfast
Queen Elizabeth Hospital Birmingham
RECRUITING
Birmingham
Addenbrooke's Hospital
RECRUITING
Cambridge
The Beatson West of Scotland Cancer Centre
RECRUITING
Glasgow
Royal Berkshire Hospital
RECRUITING
Reading
New Cross Hospital
RECRUITING
Wolverhampton
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2022-03-25
Estimated Completion Date: 2029-10-31
Participants
Target number of participants: 760
Treatments
Experimental: Arm A - Part 1
Elranatamab
Active_comparator: Arm B - Part 1
Lenalidomide
Active_comparator: Arm B - Part 2
Lenalidomide
Experimental: Arm C - Part 2
Elranatamab
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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