A PHASE 3, OPEN-LABEL STUDY OF ELRANATAMAB MONOTHERAPY VERSUS ELOTUZUMAB, POMALIDOMIDE, DEXAMETHASONE (EPd) OR POMALIDOMIDE, BORTEZOMIB, DEXAMETHASONE (PVd) OR CARFILZOMIB, DEXAMETHASONE (Kd) IN PARTICIPANTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA WHO RECEIVED PRIOR ANTI-CD38 DIRECTED THERAPY

Status: Recruiting
Location: See all (244) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The purpose of this study is to learn about the study medicine called elranatamab.This study aims to compare elranatamab to other medicines for the treatment of MM (a type of cancer). This study is seeking participants who: * Are 18 years of age or older and have MM. * Have received treatments before for MM. * Have MM that has returned or not responded to their most recent treatment. Half of the participants will receive elranatamab. The other half of participants will receive a combination therapy selected by the study doctor. The selected combination therapy will include 2 to 3 different medicines commonly used to treat MM. Elranatamab will be given as a shot under the skin at the study clinic about once a week. This may change to a smaller number of shots later in the study. The medicines in the combination therapy will be taken by mouth (at home or at the study clinic) AND will be given either as: * a shot under the skin at the study clinic * through a needle in the vein at the study clinic The number of times these medicines will be taken depends on what combination therapy the study doctor selects. Participants may continue to receive elranatamab or a combination therapy until their MM is no longer responding. The study team will see how each participant is doing with the study treatment during regular visits at the study clinic. The study team will continue to follow-up with participants after study treatment with telephone contacts (or visits). The study will compare the experiences of people receiving elranatamab to those people receiving a combination therapy. This will help learn about the safety and how effective elranatamab is.

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

• Prior diagnosis of multiple myeloma as defined by International Myeloma Working Group (IMWG) criteria and previously received 1 to 4 prior lines of therapy including prior anti-cluster of differentiation 38 (CD38) antibody and prior lenalidomide.

• Documented evidence of progressive disease or failure to achieve a response to last line of therapy per IMWG criteria.

• Measurable disease defined as at least 1 of the following: (a) Serum M-protein ≥0.5 g/dL; (b) Urinary M-protein excretion ≥200 mg/24 hours; (c) Serum involved immunoglobulin FLC ≥10 mg/dL AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).

• Have clinical laboratory values within the specified range.

• ECOG (Eastern Cooperative Oncology Group) performance status ≤2.

• Not pregnant or breastfeeding and willing to use contraception.

Locations
United States
Alabama
Infirmary Cancer Care
RECRUITING
Mobile
Arizona
Western Regional Medical Center, Inc. dba. City of Hope Phoenix
RECRUITING
Goodyear
California
Beverly Hills Cancer Center
RECRUITING
Beverly Hills
Community Cancer Institute
RECRUITING
Clovis
Clinical Research Advisors (Encino Satellite Location)
RECRUITING
Encino
Hoag Health Center Irvine
RECRUITING
Irvine
Hoag Hospital Irvine
RECRUITING
Irvine
Clinical Research Advisors (Korea Town Satellite Location)
RECRUITING
Los Angeles
Clinical Research Advisors (West Hollywood Satellite Location)
RECRUITING
Los Angeles
Valkyrie Clinical Trials
RECRUITING
Los Angeles
Hoag Memorial Hospital Presbyterian
RECRUITING
Newport Beach
Mission Community Hospital (Satellite Site)
RECRUITING
Panorama City
University of California
RECRUITING
Sacramento
University of California Davis (UC Davis) Comprehensive Cancer Center
RECRUITING
Sacramento
Colorado
UCHealth Harmony
RECRUITING
Fort Collins
UCHealth Poudre Valley Hospital
RECRUITING
Fort Collins
UCHealth Greeley Hospital
RECRUITING
Greeley
UCHealth Longs Peak Hospital
RECRUITING
Longmont
UCHealth Longs Peak Medical Center
RECRUITING
Longmont
UCHealth - Medical Center of the Rockies
RECRUITING
Loveland
Florida
Baptist Hospital of Miami
RECRUITING
Miami
BRCR Global
RECRUITING
Plantation
BRCR Global - Tamarac
RECRUITING
Tamarac
Illinois
Midwestern Regional Medical Center, Inc. dba City of Hope Chicago
NOT_YET_RECRUITING
Zion
Indiana
Community Health Network, Inc.
RECRUITING
Indianapolis
Community Health Network, Inc.
RECRUITING
Indianapolis
Community Health Network, Inc.
RECRUITING
Indianapolis
Kansas
American Oncology Partners, P.A. Dba MidAmerica Cancer Care
RECRUITING
Kansas City
Ascentist Doctors' Hospital
RECRUITING
Leawood
American Oncology Partners, P.A. Dba MidAmerica Cancer Care
RECRUITING
Merriam
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
BIDMC Research Pharmacy
RECRUITING
Boston
Missouri
American Oncology Partners, P.A. Dba MidAmerica Cancer Care
RECRUITING
Belton
MIVA Medical
RECRUITING
Independence
American Oncology Partners, P.A. Dba MidAmerica Cancer Care
RECRUITING
Kansas City
North Carolina
Brody school of Medicine at East Carolina University
RECRUITING
Greenville
ECU Health Medical Center
RECRUITING
Greenville
Nebraska
Bryan Medical Center
RECRUITING
Lincoln
NHO Revive Research Institute, LLC
RECRUITING
Lincoln
New Jersey
Atlantic Health System Morristown Medical Center
RECRUITING
Morristown
New York
WMCHealth Advanced Physician Services
RECRUITING
Hawthorne
Cayuga Cancer Center at Cayuga Park
ACTIVE_NOT_RECRUITING
Ithaca
Cayuga Medical Center
ACTIVE_NOT_RECRUITING
Ithaca
Northwell Health/ RJ Zuckerberg Cancer Center
RECRUITING
Lake Success
North Shore University Hospital
RECRUITING
Manhasset
Long Island Jewish Medical Center
RECRUITING
New Hyde Park
Westchester Medical Center
RECRUITING
Valhalla
Ohio
Oncology Hematology Care Clinical Trials, LLC
RECRUITING
Cincinnati
Oncology Hematology Care Clinical Trials, LLC
RECRUITING
Cincinnati
Oncology Hematology Care Clinical Trials, LLC
RECRUITING
Cincinnati
Oncology Hematology Care Clinical Trials, LLC
RECRUITING
Cincinnati
The Jewish Hospital
RECRUITING
Cincinnati
TriHealth Cancer Institute-Good Samaritan Hospital
RECRUITING
Cincinnati
Cleveland Clinic
RECRUITING
Cleveland
Pennsylvania
AHN West Penn Hospital
RECRUITING
Pittsburgh
Rhode Island
Brown University Health Cancer Institute
RECRUITING
Providence
The Miriam Hospital
RECRUITING
Providence
South Carolina
St Francis Cancer Center
RECRUITING
Greenville
Texas
Baylor University Medical Center
RECRUITING
Dallas
Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy
RECRUITING
Dallas
Houston Methodist Hospital
RECRUITING
Houston
Houston Methodist Willowbrook Hospital
RECRUITING
Houston
US Oncology Investigational Products Center (IPC)
RECRUITING
Irving
Houston Methodist Sugar Land Hospital
RECRUITING
Sugar Land
Baylor Scott & White Medical Center - Temple
RECRUITING
Temple
Wisconsin
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
RECRUITING
Madison
University of Wisconsin Carbone Cancer Center-University Hospital
RECRUITING
Madison
West Virginia
WVU Cancer Institute
RECRUITING
Morgantown
Other Locations
Argentina
Instituto Alexander Fleming
RECRUITING
Ciudad Autónoma De Buenos Aires
Hospital Italiano de Buenos Aires
RECRUITING
Ciudad De Buenos Aires
Hospital Italiano de La Plata
RECRUITING
La Plata
Hospital Universitario Austral
RECRUITING
Pilar
Australia
Sunshine Coast University Hospital
RECRUITING
Birtinya
Blacktown Hospital
RECRUITING
Blacktown
Royal Brisbane and Women's Hospital
RECRUITING
Brisbane
Concord Repatriation General Hospital
RECRUITING
Concord
St Vincent's Hospital (Melbourne)
RECRUITING
Fitzroy
Barwon Health
RECRUITING
Geelong
Sir Charles Gairdner Hospital, Department of Medical Oncology
RECRUITING
Nedlands
Belgium
UZ Brussel
RECRUITING
Brussels
UZ Gent
RECRUITING
Ghent
Grand Hôpital de Charleroi
RECRUITING
Gilly
Centre Hospitalier Epicura
RECRUITING
Hornu
Clinique Saint Pierre
NOT_YET_RECRUITING
Ottignies
AZ Delta vzw
RECRUITING
Roeselare
CHR Verviers - La Tourelle
RECRUITING
Verviers
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
RECRUITING
Yvoir
Brazil
Hospital Amaral Carvalho
RECRUITING
Jaú
Instituto Oncomed de Educação e Pesquisa
NOT_YET_RECRUITING
Niterói
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 Moinhos de Vento
RECRUITING
Porto Alegre
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP)
RECRUITING
Ribeirão Preto
Americas Centro de Oncologia Integrado
RECRUITING
Rio De Janeiro
Instituto de Educação, Pesquisa e Gestão em Saúde
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
NOT_YET_RECRUITING
Salvador
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 do Coracao
RECRUITING
São Paulo
HU UNIFESP / SPDM - Hospital São Paulo
RECRUITING
São Paulo
Instituto D'Or de Pesquisa e Ensino (IDOR)
RECRUITING
São Paulo
Instituto D'Or de Pesquisa e Ensino (IDOR)
RECRUITING
São Paulo
Universidade Federal de Sao Paulo
RECRUITING
São Paulo
Clínica Médica São Germano LTDA
RECRUITING
Sp
Canada
Cross Cancer Institute
NOT_YET_RECRUITING
Edmonton
The Moncton Hospital
RECRUITING
Moncton
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎ
RECRUITING
Montreal
Jewish General Hospital
RECRUITING
Montreal
Croatia
Klinicki bolnicki centar Osijek
NOT_YET_RECRUITING
Osijek
Klinicki bolnicki centar Rijeka
NOT_YET_RECRUITING
Rijeka
Klinicki bolnicki centar Split
NOT_YET_RECRUITING
Split
Klinicka bolnica Dubrava
RECRUITING
Zagreb
Klinicka bolnica Merkur
NOT_YET_RECRUITING
Zagreb
University Hospital Center Zagreb
NOT_YET_RECRUITING
Zagreb
Denmark
Aalborg Universitetshospital, Syd
RECRUITING
Aalborg
Aarhus Universitetshospital, Skejby
RECRUITING
Aarhus
Rigshospitalet
RECRUITING
Copenhagen
Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
RECRUITING
Helsinki
Kuopion Yliopistollinen Sairaala
RECRUITING
Kuopio
Oulun yliopistollinen sairaala
RECRUITING
Oulu
Tampereen yliopistollinen sairaala
RECRUITING
Tampere
Turku University Hospital
RECRUITING
Turku
France
Centre Hospitalier de la Côte Basque
RECRUITING
Bayonne
Hôpital NOVO
RECRUITING
Cergy-pontoise
Henri Mondor Hospital
RECRUITING
Créteil
Centre Hospitalier de Dunkerque
NOT_YET_RECRUITING
Dunkirk
CHD Vendee
RECRUITING
La Roche-sur-yon
Centre Hospitalier du Mans
RECRUITING
Le Mans
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu
NOT_YET_RECRUITING
Nantes
Hôpital Universitaire Necker Enfants Malades
RECRUITING
Paris
Hopitaux Universitaires Paris Centre-Hopital Cochin
RECRUITING
Paris
CHU Bordeaux Haut-Leveque
RECRUITING
Pessac
Centre Hospitalier Universitaire de Poitiers
NOT_YET_RECRUITING
Poitiers
Hôpital NOVO
RECRUITING
Pontoise
Centre Hospitalier de Cornouaille
RECRUITING
Quimper
Institut Universitaire du Cancer Toulouse - Oncopole - CHU de TOULOUSE
NOT_YET_RECRUITING
Toulouse
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
RECRUITING
Tours
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
RECRUITING
Vandœuvre-lès-nancy
Centre Hospitalier Bretagne Atlantique
RECRUITING
Vannes
Centre Hospitalier Bretagne Atlantique
RECRUITING
Vannes
Germany
Vivantes Klinikum Am Urban
RECRUITING
Berlin
Vivantes Klinikum Am Urban
RECRUITING
Berlin
Universitätsklinikum Bonn
RECRUITING
Bonn
Medizinische Universität Lausitz - Carl Thiem
RECRUITING
Cottbus
Universitaetsklinikum Freiburg
RECRUITING
Freiburg Im Breisgau
Asklepios Altona
RECRUITING
Hamburg
St. Barbara-Klinik Hamm-Heessen
RECRUITING
Hamm
Universitätsklinikum Jena
RECRUITING
Jena
Klinikum Nürnberg Nord
RECRUITING
Nuremberg
Diakonissen-Stiftungs-Krankenhaus Speyer
RECRUITING
Speyer
Robert Bosch Krankenhaus GmbH
RECRUITING
Stuttgart
Universitaetsklinikum Ulm
RECRUITING
Ulm
Greece
University General Hospital of Alexandroupoli
RECRUITING
Alexandroupoli
Alexandra General Hospital of Athens
RECRUITING
Athens
Evangelismos General Hospital of Athens
RECRUITING
Athens
University Hospital of Ioannina
RECRUITING
Ioannina
G. Papanikolaou General Hospital
RECRUITING
Thessaloniki
Theagenio Cancer Hospital of Thessaloniki
RECRUITING
Thessaloniki
Israel
Soroka Medical Center
NOT_YET_RECRUITING
Beersheba
Hadassah Medical Center
RECRUITING
Jerusalem
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
NOT_YET_RECRUITING
Ramat Gan
Sourasky Medical Center
NOT_YET_RECRUITING
Tel Aviv
Italy
Azienda Ospedaliero Universitaria delle Marche
RECRUITING
Ancona
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
RECRUITING
Bologna
Azienda Ospedaliera Universitaria Careggi
RECRUITING
Florence
Azienda Socio Sanitaria Ovest milanese
RECRUITING
Legnano
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) Dino Amadori
RECRUITING
Meldola
Istituto Europeo di Oncologia IRCCS
RECRUITING
Milan
P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO
RECRUITING
Milan
A.O.U. Policlinico Paolo Giaccone
RECRUITING
Palermo
Ospedale Civile dello Spirito Santo
RECRUITING
Pescara
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
RECRUITING
Turin
Japan
Nippon Medical School Hospital
RECRUITING
Bunkyo-ku
Kagoshima University Hospital
RECRUITING
Kagoshima
Kobe City Medical Center General Hospital
RECRUITING
Kobe
Yamanashi Prefectural Central Hospital
RECRUITING
Kofu
Japanese Foundation for Cancer Research
RECRUITING
Koto
University Hospital,Kyoto Prefectural University of Medicine
RECRUITING
Kyoto
Gunma University Hospital
RECRUITING
Maebashi
Ehime Prefectural Central Hospital
RECRUITING
Matsuyama
Shizuoka Cancer Center
RECRUITING
Nagaizumi-cho
Nagoya City University Hospital
RECRUITING
Nagoya
Ogaki Municipal Hospital
RECRUITING
Ōgaki
National Hospital Organization Okayama Medical Center
RECRUITING
Okayama
Okayama Rosai Hospital
RECRUITING
Okayama
National Hospital Organization Shibukawa Medical Center
RECRUITING
Shibukawa
Iwate Medical University Hospital
RECRUITING
Shiwa-gun Yahaba-cho
Toyohashi Municipal Hospital
RECRUITING
Toyohashi
Yamagata University Hospital
RECRUITING
Yamagata
Netherlands
Albert Schweitzer Ziekenhuis, locatie Dordwijk
RECRUITING
Dordrecht
Maastricht UMC+
RECRUITING
Maastricht
Erasmus Medisch Centrum
NOT_YET_RECRUITING
Rotterdam
Norway
Akershus Universitetssykehus
RECRUITING
Lørenskog
Oslo Universitetssykehus Ullevål
RECRUITING
Oslo
Sykehuset i Vestfold
RECRUITING
Tønsberg
St. Olavs Hospital
RECRUITING
Trondheim
Portugal
2Ca Braga
RECRUITING
Braga
Unidade Local de Saúde de Coimbra, E.P.E.
NOT_YET_RECRUITING
Coimbra
Instituto Português de Oncologia de Lisboa Francisco Gentil
RECRUITING
Lisbon
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Seoul
Slovakia
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
RECRUITING
Banská Bystrica
Narodny onkologicky ustav
RECRUITING
Bratislava
Univerzitna nemocnica Martin
RECRUITING
Martin
Slovenia
University Medical Centre Ljubljana
NOT_YET_RECRUITING
Ljubljana
Spain
Institut Català d'Oncologia (ICO) - Badalona
RECRUITING
Badalona
OSI Ezkerraldea-Enkarterri-Cruces - Hospital Universitario Cruces
RECRUITING
Barakaldo
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Institut Català d'Oncologia (ICO) - Girona
RECRUITING
Girona
Hospital General Universitario Gregorio Marañon
RECRUITING
Madrid
Hospital Universitario HM Sanchinarro
RECRUITING
Madrid
Hospital Universitario Infanta Leonor
RECRUITING
Madrid
H.R.U Málaga - Hospital General
RECRUITING
Málaga
Hospital General Universitario Morales Meseguer
RECRUITING
Murcia
Centro de Diagnóstico y Resonancia Magnética
RECRUITING
Salamanca
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
RECRUITING
Salamanca
Hospital Universitari Mutua Terrassa
RECRUITING
Terrassa
ASCIRES ECG Médica S.L
RECRUITING
Valencia
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Sweden
Falu Lasarett
RECRUITING
Falun
Universitetssjukhuset Örebro
RECRUITING
Örebro
Taiwan
China Medical University Hospital
RECRUITING
Taichung
United Kingdom
Queen Elizabeth Hospital Birmingham
RECRUITING
Birmingham
Glan Clwyd Hospital
NOT_YET_RECRUITING
Bodelwyddan
Royal Bournemouth Hospital
RECRUITING
Bournemouth
Kent and Canterbury Hospital
RECRUITING
Canterbury
Eastbourne District General Hospital
NOT_YET_RECRUITING
Eastbourne
Guy's & St Thomas' NHS Foundation Trust
RECRUITING
London
Hammersmith Hospital
RECRUITING
London
King's College Hospital
RECRUITING
London
Royal Marsden Hospital (Sutton)
RECRUITING
London
St Bartholomew's Hospital
RECRUITING
London
Maidstone Hospital
RECRUITING
Maidstone
Milton Keynes Hospital
RECRUITING
Milton Keynes
Churchill Hospital
RECRUITING
Oxford
Poole Hospital
RECRUITING
Poole
Royal Stoke University Hospital
RECRUITING
Stoke-on-trent
New Cross Hospital
RECRUITING
Wolverhampton
Worthing Hospital
RECRUITING
Worthing
Contact Information
Primary
Pfizer CT.gov Call Center
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Time Frame
Start Date: 2024-02-08
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 492
Treatments
Experimental: Elranatamab
Participants will receive elranatamab monotherapy
Active_comparator: Investigator's Choice
Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)
Related Therapeutic Areas
Sponsors
Leads: Pfizer

This content was sourced from clinicaltrials.gov

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