MagnetisMM-32: A Study to Learn About the Study Medicine Called Elranatamab in People With Multiple Myeloma (MM) That Has Come Back After Taking Other Treatments (Including Prior Treatment With an Anti-CD38 Antibody and Lenalidomide)
- Conditions
- Multiple Myeloma
- Interventions
- Registration Number
- NCT06152575
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 492
- 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.
- Smoldering multiple myeloma.
- Plasma cell leukemia.
- Amyloidosis.
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy and skin abnormalities (POEMS) syndrome.
- Known central nervous system (CNS) involvement or clinical signs of myelomatous meningeal involvement.
- Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
- Any active, uncontrolled bacterial, fungal, or viral infection.
- Any other active malignancy within 3 years prior to enrolment (exceptions include, adequately treated basal cell or squamous cell skin cancer, carcinoma in situ)
- Previous treatment with a B cell maturation antigen (BCMA)-directed therapy or CD3-redirecting therapy.
- Unable to receive investigator's choice therapy.
- Live attenuated vaccine within 4 weeks of the first dose of study intervention.
- Administration with an investigational product (e.g. drug or vaccine) within 30 days preceding the first dose of study intervention used in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elranatamab Elranatamab Participants will receive elranatamab monotherapy Investigator's Choice Elotuzumab Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd) Investigator's Choice Pomalidomide Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd) Investigator's Choice Bortezomib Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd) Investigator's Choice Carfilzomib Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd) Investigator's Choice Dexamethasone Participants will receive either Elotuzumab, Pomalidomide and Dexamethasone (EPd), or Pomalidomide, Bortezomib and Dexamethasone (PVd), or Carfilzomib and Dexamethasone (Kd)
- Primary Outcome Measures
Name Time Method Progression free survival per International Myeloma Working Group criteria Up to approximately 5 years From date of randomization to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
- Secondary Outcome Measures
Name Time Method Overall survival Up to approximately 5 years From date of randomization to date of discontinuation from study, death, or censoring, whichever occurs first
Progression free survival on next-line treatment per International Myeloma Working Group criteria Up to approximately 5 years From date of randomization to date of second objective disease progression, discontinuation from the study, death, or censoring, whichever occurs first
Objective response rate per International Myeloma Working Group criteria Up to approximately 5 years From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy
Free elranatamab serum trough concentration [Ctrough] From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab Elranatamab immunogenicity by anti-drug antibodies against elranatamab From date of first dose of elranatamab up to approximately 14 days after last dose of elranatamab Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 From date of informed consent up to approximately 35 days after last administration of study intervention Change from baseline scores
Health-related quality of life by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Myeloma 20 From date of informed consent up to approximately 35 days after last administration of study intervention Change from baseline scores
Duration of response per International Myeloma Working Group criteria Up to approximately 5 years From date of confirmed objective response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
Very good partial response or better response rate per International Myeloma Working Group criteria Up to approximately 5 years From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
Complete response rate per International Myeloma Working Group criteria Up to approximately 5 years From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
Time to response per International Myeloma Working Group criteria Up to approximately 5 years From date of randomization to date of confirmed objective response
Duration of complete response per International Myeloma Working Group criteria Up to approximately 5 years From date of confirmed complete response to date of progressive disease, discontinuation from study, death, or censoring, whichever occurs first
Duration of minimal residual disease negativity rate per International Myeloma Working Group criteria Up to approximately 5 years From date of minimal residual disease negativity to date of relapse, death, or censoring, whichever occurs first
Minimal residual disease negativity rate per International Myeloma Working Group criteria Up to approximately 5 years From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
Sustained minimal residual disease negativity rate per International Myeloma Working Group criteria Up to approximately 5 years From date of randomization to date of progressive disease, discontinuation from study, death, or start of new anticancer therapy, whichever occurs first
Frequency of abnormal laboratory results From date of first dose of study intervention up to 90 days after last study intervention administration Frequency of treatment-emergent adverse events From date of first dose of study intervention up to 90 days after last study intervention administration
Trial Locations
- Locations (171)
Hôpital NOVO
🇫🇷Pontoise, Val-d'oise, France
Infirmary Cancer Care
🇺🇸Mobile, Alabama, United States
Beverly Hills Cancer Center
🇺🇸Beverly Hills, California, United States
Community Cancer Institute
🇺🇸Clovis, California, United States
Clinical Research Advisors (Encino Satellite Location)
🇺🇸Encino, California, United States
Clinical Research Advisors (Korea Town Satellite Location)
🇺🇸Los Angeles, California, United States
Clinical Research Advisors (West Hollywood Satellite Location)
🇺🇸Los Angeles, California, United States
University of California Davis (UC Davis) Comprehensive Cancer Center
🇺🇸Sacramento, California, United States
University of California
🇺🇸Sacramento, California, United States
UCHealth Harmony
🇺🇸Fort Collins, Colorado, United States
Longs Peak Hospital
🇺🇸Longmont, Colorado, United States
Miami Cancer Institute at Baptist Health, Inc.
🇺🇸Miami, Florida, United States
BRCR Global
🇺🇸Plantation, Florida, United States
BRCR Global - Tamarac
🇺🇸Tamarac, Florida, United States
Community Health Network, Inc.
🇺🇸Indianapolis, Indiana, United States
Bryan Medical Center
🇺🇸Lincoln, Nebraska, United States
NHO Revive Research Institute, LLC
🇺🇸Lincoln, Nebraska, United States
Atlantic Health System Morristown Medical Center
🇺🇸Morristown, New Jersey, United States
WMCHealth Advanced Physician Services
🇺🇸Hawthorne, New York, United States
Cayuga Cancer Center at Cayuga Park
🇺🇸Ithaca, New York, United States
Cayuga Medical Center
🇺🇸Ithaca, New York, United States
Westchester Medical Center
🇺🇸Valhalla, New York, United States
Brody school of Medicine at East Carolina University
🇺🇸Greenville, North Carolina, United States
ECU Health Medical Center
🇺🇸Greenville, North Carolina, United States
Oncology Hematology Care Clinical Trials, LLC
🇺🇸Cincinnati, Ohio, United States
TriHealth Cancer Institute-Good Samaritan Hospital
🇺🇸Cincinnati, Ohio, United States
The Jewish Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
St Francis Cancer Center
🇺🇸Greenville, South Carolina, United States
Baylor University Medical Center, Investigational Drug Services, Department of Pharmacy
🇺🇸Dallas, Texas, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
US Oncology Investigational Products Center (IPC)
🇺🇸Irving, Texas, United States
Houston Methodist Willowbrook Hospital
🇺🇸Houston, Texas, United States
Baylor Scott & White Medical Center - Temple
🇺🇸Temple, Texas, United States
WVU Cancer Institute
🇺🇸Morgantown, West Virginia, United States
Houston Methodist Sugar Land Hospital
🇺🇸Sugar Land, Texas, United States
University of Wisconsin Carbone Cancer Center-University Hospital
🇺🇸Madison, Wisconsin, United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
🇺🇸Madison, Wisconsin, United States
University of Wisconsin Clinical Science Center
🇺🇸Madison, Wisconsin, United States
Instituto Alexander Fleming
🇦🇷Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Hospital Universitario Austral
🇦🇷Pilar, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires
🇦🇷Ciudad de Buenos Aires, Ciudad Autónoma DE Buenos Aires, Argentina
Hospital Italiano de La Plata
🇦🇷La Plata, Argentina
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
UZ Brussel
🇧🇪Brussels, Bruxelles-capitale, Région DE, Belgium
Centro de Pesquisa Clínica - Área Administrativa
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Hospital Mae de Deus
🇧🇷Porto Alegre, RIO Grande DO SUL, Brazil
Grand Hôpital de Charleroi
🇧🇪Gilly, Hainaut, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
🇧🇪Yvoir, Namur, Belgium
UZ Gent
🇧🇪Gent, Oost-vlaanderen, Belgium
Epicura
🇧🇪Hornu, Hainaut, Belgium
CHR Verviers - La Tourelle
🇧🇪Verviers, Liège, Belgium
Instituto D'Or de Pesquisa e Ensino (IDOR)
🇧🇷São Paulo, Brazil
Clínica Médica São Germano LTDA
🇧🇷SP, SÃO Paulo, Brazil
Instituto de Educação, Pesquisa e Gestão em Saúde
🇧🇷Rio de Janeiro, Brazil
Americas Centro de Oncologia Integrado
🇧🇷Rio de Janeiro, Brazil
ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de Higienópolis
🇧🇷São Paulo, Brazil
Hospital do Coracao
🇧🇷São Paulo, Brazil
HU UNIFESP / SPDM - Hospital São Paulo
🇧🇷São Paulo, Brazil
Universidade Federal de Sao Paulo
🇧🇷São Paulo, Brazil
Clínica Médica São Germano S/S Ltda
🇧🇷São Paulo, Brazil
Cross Cancer Institute
🇨🇦Edmonton, Alberta, Canada
The Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
Centre Hospitalier de Dunkerque
🇫🇷Dunkirk, Nord-pas-de-calais, France
Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎ
🇨🇦Montreal, Quebec, Canada
Fakultní nemocnice Brno Bohunice
🇨🇿Brno, Brno-město, Czechia
Fakultni nemocnice Olomouc
🇨🇿Olomouc, Olomoucký KRAJ, Czechia
Fakultni nemocnice Kralovske Vinohrady
🇨🇿Prague, Praha 10, Czechia
Vseobecna fakultni nemocnice v Praze
🇨🇿Praha 2, Czechia
Rigshospitalet
🇩🇰Copenhagen, Hovedstaden, Denmark
Aarhus Universitetshospital, Skejby
🇩🇰Aarhus, Midtjylland, Denmark
Aalborg Universitetshospital, Syd
🇩🇰Aalborg, Nordjylland, Denmark
Tampereen yliopistollinen sairaala
🇫🇮Tampere, Pirkanmaa, Finland
Oulun yliopistollinen sairaala
🇫🇮Oulu, Pohjois-pohjanmaa, Finland
Kuopion Yliopistollinen Sairaala
🇫🇮Kuopio, Pohjois-savo, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
🇫🇮Helsinki, Uusimaa, Finland
Turku University Hospital
🇫🇮Turku, Varsinais-suomi, Finland
CHU Bordeaux Haut-Leveque
🇫🇷Pessac, Aquitaine, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
🇫🇷Vandoeuvre lès Nancy, Lorraine, France
Henri Mondor Hospital
🇫🇷Créteil, Val-de-marne, France
CHD Vendee
🇫🇷La Roche-sur-Yon, Vendée, France
Centre Hospitalier de la Côte Basque
🇫🇷Bayonne, France
Centre Hospitalier du Mans
🇫🇷Le Mans, France
Hôpital Universitaire Necker Enfants Malades
🇫🇷Paris, France
Hopitaux Universitaires Paris Centre-Hopital Cochin
🇫🇷Paris, France
Centre Hospitalier de Cornouaille
🇫🇷Quimper, France
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau
🇫🇷Tours, France
Universitaetsklinikum Freiburg
🇩🇪Freiburg, Baden-württemberg, Germany
Universitaetsklinikum Ulm
🇩🇪Ulm, Baden-württemberg, Germany
Klinikum Nürnberg Nord
🇩🇪Nürnberg, Bayern, Germany
Universitätsklinikum Jena
🇩🇪Jena, Thüringen, Germany
Vivantes Klinikum Am Urban
🇩🇪Berlin, Germany
Medizinische Universität Lausitz - Carl Thiem
🇩🇪Cottbus, Germany
Asklepios Altona
🇩🇪Hamburg, Germany
St. Barbara-Klinik Hamm-Heessen
🇩🇪Hamm, Germany
Diakonissen-Stiftungs-Krankenhaus Speyer
🇩🇪Speyer, Germany
University Hospital of Alexandroupolis
🇬🇷Alexandroupolis, Anatolikí Makedonía KAI Thráki, Greece
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
G. Papanikolaou General Hospital
🇬🇷Thessaloniki, Thessaloníki, Greece
University Hospital of Ioannina
🇬🇷Ioannina, Ípeiros, Greece
Rabin Medical Center
🇮🇱Petah-Tikva, Hamerkaz, Israel
Sheba Medical Center
🇮🇱Ramat Gan, Hamerkaz, Israel
Sourasky Medical Center
🇮🇱Tel Aviv, Tell Abīb, Israel
Hadassah Medical Center
🇮🇱Jerusalem, Yerushalayim, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"
🇮🇹Meldola, Emilia-romagna, Italy
P.O. San Carlo Borromeo- ASST SANTI PAOLO E CARLO
🇮🇹Milano, Lombardia, Italy
Azienda Ospedaliero Universitaria delle Marche
🇮🇹Ancona, Marche, Italy
Azienda Socio Sanitaria Ovest milanese
🇮🇹Legnano, Milano, Italy
A.O.U. Policlinico Paolo Giaccone
🇮🇹Palermo, Sicilia, Italy
Azienda Ospedaliera Universitaria Careggi
🇮🇹Firenze, Toscana, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
🇮🇹Bologna, Italy
Istituto Europeo di Oncologia IRCCS
🇮🇹Milano, Italy
Ospedale Civile dello Spirito Santo
🇮🇹Pescara, Italy
Toyohashi Municipal Hospital
🇯🇵Toyohashi, Aichi, Japan
Ehime Prefectural Central Hospital
🇯🇵Matsuyama, Ehime, Japan
Nagoya City University Hospital
🇯🇵Nagoya, Aichi, Japan
Ogaki Municipal Hospital
🇯🇵Ogaki, Gifu, Japan
Gunma University Hospital
🇯🇵Maebashi, Gunma, Japan
National Hospital Organization Shibukawa Medical Center
🇯🇵Shibukawa, Gunma, Japan
Iwate Medical University Hospital
🇯🇵Shiwa-gun Yahaba-cho, Iwate, Japan
Shizuoka Cancer Center
🇯🇵Nagaizumi-cho, Shizuoka, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Hyogo, Japan
Nippon Medical School Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Japanese Foundation for Cancer Research
🇯🇵Koto, Tokyo, Japan
Yamanashi Prefectural Central Hospital
🇯🇵Kofu-shi, Yamanashi, Japan
Kagoshima University Hospital
🇯🇵Kagoshima, Japan
University Hospital,Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
National Hospital Organization Okayama Medical Center
🇯🇵Okayama, Japan
Okayama Rosai Hospital
🇯🇵Okayama, Japan
Yamagata University Hospital
🇯🇵Yamagata, Japan
Seoul National University Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Maastricht UMC+
🇳🇱Maastricht, Limburg, Netherlands
Albert Schweitzer Ziekenhuis, locatie Dordwijk
🇳🇱Dordrecht, Zuid-holland, Netherlands
St. Olavs Hospital
🇳🇴Trondheim, Sør-trøndelag, Norway
Akershus Universitetssykehus
🇳🇴Lørenskog, Akershus, Norway
Sykehuset i Vestfold
🇳🇴Tønsberg, Vestfold, Norway
Oslo Universitetssykehus Ullevål
🇳🇴Oslo, Norway
Institut Català d'Oncologia (ICO) - Badalona
🇪🇸Badalona, Barcelona [barcelona], Spain
Cetir-Ascires
🇪🇸Barcelona, Barcelona [barcelona], Spain
Hospital Universitari Mutua Terrassa
🇪🇸Terrassa, Barcelona [barcelona], Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Catalunya [cataluña], Spain
Hospital General Universitario Morales Meseguer
🇪🇸Murcia, Galicia [galicia], Spain
Institut Català d'Oncologia (ICO) - Girona
🇪🇸Girona, Girona [gerona], Spain
Hospital Universitario Infanta Leonor
🇪🇸Madrid, Madrid, Comunidad DE, Spain
ASCIRES ECG Médica S.L
🇪🇸València, Valenciana, Comunitat, Spain
Hospital General Universitario Gregorio Marañon
🇪🇸Madrid, Spain
Hospital Universitario HM Sanchinarro
🇪🇸Madrid, Spain
H.R.U Málaga - Hospital General
🇪🇸Málaga, Spain
Centro de Diagnóstico y Resonancia Magnética
🇪🇸Salamanca, Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
🇪🇸Salamanca, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸València, Spain
Falu Lasarett
🇸🇪Falun, Sweden
Universitetssjukhuset Örebro
🇸🇪Örebro, Örebro LÄN [se-18], Sweden
China Medical University Hospital
🇨🇳Taichung, Taiwan
Royal Bournemouth Hospital
🇬🇧Bournemouth, Dorset, United Kingdom
Poole Hospital
🇬🇧Poole, Dorset, United Kingdom
Eastbourne District General Hospital
🇬🇧Eastbourne, EAST Sussex, United Kingdom
Queen Elizabeth Hospital Birmingham
🇬🇧Birmingham, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, Kent, United Kingdom
St Bartholomew's Hospital
🇬🇧London, London, CITY OF, United Kingdom
King's College Hospital
🇬🇧London, London, CITY OF, United Kingdom
Hammersmith Hospital
🇬🇧London, London, CITY OF, United Kingdom
Churchill Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom
Royal Stoke University Hospital
🇬🇧Stoke-on-Trent, Staffordshire, United Kingdom
Royal Marsden Hospital (Sutton)
🇬🇧London, Sutton, United Kingdom
Kent and Canterbury Hospital
🇬🇧Canterbury, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom