MagnetisMM-5: Study of Elranatamab (PF-06863135) Monotherapy and Elranatamab + Daratumumab Versus Daratumumab + Pomalidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma (MAGNETISMM-5)
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Elranatamab, PF-06863135, B-Cell Maturation Antigen, BCMA, Bispecific antibody, BCMA-CD3 bispecific antibody, Daratumumab, Pomalidomide, Multiple myeloma, Relapsed multiple myeloma, Refractory multiple myeloma, MagnetisMM-5
Eligibility Criteria
Inclusion Criteria:
- Prior diagnosis of multiple myeloma 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.
- Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (<0.26 or >1.65).
- Prior anti-multiple myeloma therapy including treatment with lenalidomide and a proteasome inhibitor.
- ECOG performance status ≤2.
- Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
- Not pregnant and willing to use contraception.
Exclusion Criteria:
- Smoldering multiple myeloma.
- Plasma cell leukemia.
- Amyloidosis.
- POEMS Syndrome.
- Stem cell transplant within 12 weeks prior to enrolment, or active graft versus host disease.
- Active HBV, HCV, SARS-CoV2, HIV, or any active, uncontrolled bacterial, fungal, or viral infection.
- Any other active malignancy within 3 years prior to enrolment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.
- Previous treatment with a BCMA-directed therapy.
- Anti-CD38-directed therapy within 6 months preceding the first dose of treatment in this study.
- Live attenuated vaccine within 4 weeks of the first dose of study intervention.
- Administration with an investigational product (e.g. drug or vaccine) concurrent with study intervention or within 30 days preceding the first dose of study intervention used in this study.
Sites / Locations
- Clovis Community Medical CenterRecruiting
- Community Cancer InstituteRecruiting
- University of California San FranciscoRecruiting
- Community Regional Medical CenterRecruiting
- Tulane Cancer CenterRecruiting
- Tulane Medical CenterRecruiting
- Alexander Fleming S.A (Instituto Medico Especializado Alexander Fleming)Recruiting
- FUNDALEU - Fundacion para combatir la LeucemiaRecruiting
- FUNDALEU -Fundación para combatir la leucemiaRecruiting
- FUNDALEURecruiting
- Hospital Universitario AustralRecruiting
- Hospital Italiano de la PlataRecruiting
- Sanatorio de La MujerRecruiting
- Pindara Private HospitalRecruiting
- QScan Radiology ClinicsRecruiting
- Gallipoli Medical Research FoundationRecruiting
- Greenslopes Private HospitalRecruiting
- Princess Alexandra HospitalRecruiting
- Epworth FreemasonsRecruiting
- St Vincent's Hospital (Melbourne)Recruiting
- Barwon HealthRecruiting
- The Alfred HospitalRecruiting
- Epworth HealthcareRecruiting
- Slade PharmacyRecruiting
- Universitätsklinikum KremsRecruiting
- Medizinische Universität WienRecruiting
- Universitaetsklinikum Allgemeines Krankenhaus WienRecruiting
- Klinik OttakringRecruiting
- Universitätsklinik für Innere Medizin V InnsbruckRecruiting
- Uniklinikum SalzburgRecruiting
- Medizinische Universität WienRecruiting
- Grand Hôpital de Charleroi
- CHU UCL Namur (site Godinne)Recruiting
- Instituto D'Or de Pesquisa e Ensino (IDOR) - Filial SalvadorRecruiting
- Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E PesquisaRecruiting
- Centro de Pesquisa Clínica - Área AdministrativaRecruiting
- Hospital Mae de DeusRecruiting
- Hospital Santa Cruz / Centro de PesquisaRecruiting
- BP - A Beneficencia Portuguesa de São PauloRecruiting
- Hospital Américas Medical CityRecruiting
- Instituto de Educação, Pesquisa e Gestão e SaúdeRecruiting
- Instituto de Educação, Pesquisa e Gestão em SaúdeRecruiting
- ESHO Empresa de Serviços Hospitalares S.A/ Hospital Samaritano de HigienópolisRecruiting
- HU UNIFESP / SPDM - Hospital São PauloRecruiting
- Universidade Federal de Sao PauloRecruiting
- Hospital Japonês Santa CruzRecruiting
- Clínica Médica São Germano S/S LtdaRecruiting
- Instituto D'Or de Pesquisa e Ensino (IDOR)Recruiting
- Instituto D'Or de Pesquisa e Ensino (IDOR)Recruiting
- Sociedade Beneficente Israelita Brasileira Hospital Albert EinsteinRecruiting
- Tom Baker Cancer CenterRecruiting
- Cross Cancer InstituteRecruiting
- QEII Health Sciences Centre - Victoria General SiteRecruiting
- Queen Elizabeth II Health Science CentreRecruiting
- Hamilton Health Sciences-Juravinski Cancer CentreRecruiting
- Princess Margaret Cancer CentreRecruiting
- Jewish General HospitalRecruiting
- CIUSSS de l'Est-de-l'Île-de-MontréalRecruiting
- Saskatoon Cancer CenterRecruiting
- Peking University Third HospitalRecruiting
- Beijing Peking Union Medical College HospitalRecruiting
- Fujian Medical University Union HospitalRecruiting
- Guangdong Provincial People's HospitalRecruiting
- Nanfang Hospital of Southern Medical UniversityRecruiting
- Sun Yat-sen University Cancer CenterRecruiting
- Shenzhen Second People's HospitalRecruiting
- The Second Hospital of Hebei Medical UniversityRecruiting
- Harbin Medical University Cancer HospitalRecruiting
- Henan Cancer HospitalRecruiting
- Tongji Hospital, Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
- Nanjing Drum Tower Hospital , The Affiliated Hospital of Nanjing University Medical SchoolRecruiting
- The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
- The First Affiliated Hospital of Nanchang UniversityRecruiting
- Jilin Province Cancer HospitalRecruiting
- The first hospital of Jilin UniversityRecruiting
- Jinan Central Hospital
- Shandong Provincial HospitalRecruiting
- Jinan Central HospitalRecruiting
- Institute of hematology&blood disease hospitalRecruiting
- Tianjin Medical University General HospitalRecruiting
- The First Affiliated Hospital, Zhejiang UniversityRecruiting
- The First Affiliated Hospital of Wenzhou Medical UniversityRecruiting
- Beijing Boren HospitalRecruiting
- Chongqing University Cancer HospitalRecruiting
- Jinan Central HospitalRecruiting
- Fakultní nemocnice Brno BohuniceRecruiting
- Fakultni Nemocnice PlzenRecruiting
- Fakultni poliklinikaRecruiting
- Fakultni nemocnice Hradec KraloveRecruiting
- Fakultni nemocnice OlomoucRecruiting
- Fakultni nemocnice OstravaRecruiting
- Vseobecna fakultni nemocnice v PrazeRecruiting
- Tampereen yliopistollinen sairaalaRecruiting
- Oulun yliopistollinen sairaalaRecruiting
- Kuopion Yliopistollinen SairaalaRecruiting
- Turku University HospitalRecruiting
- Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)Recruiting
- Tampereen yliopistollinen sairaalaRecruiting
- CHU Bordeaux Haut-Leveque
- Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
- Hopital Claude Huriez - CHU de LilleRecruiting
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuRecruiting
- Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-DieuRecruiting
- Hôpital Saint AntoineRecruiting
- Hopital NeckerRecruiting
- Centre Hospitalier Lyon Sud - Service d'Hematologie CliniqueRecruiting
- CHU de Poitiers, Hôpital de la Milétrie, Pôle Régional de CancérologieRecruiting
- Universitaetsklinikum Ulm
- Universitätsklinikum WürzburgRecruiting
- Universitaetsklinikum KoelnRecruiting
- Uniklinik RWTH AachenRecruiting
- Charité Universitätsmedizin BerlinRecruiting
- Staedtisches Klinikum Braunschweig gGmbHRecruiting
- Klinikum Chemnitz gGMbHRecruiting
- St. Barbara-Klinik Hamm-Heessen
- Universitätsklinikum rechts der Isar, Technische Universität München (TUM)Recruiting
- Klinikum rechts der Isar der Technischen Universität MünchenRecruiting
- Evangelismos General Hospital of AthensRecruiting
- Evangelismos HospitalRecruiting
- Alexandra General Hospital of AthensRecruiting
- Theageneio Cancer Hospital of ThessalonikiRecruiting
- University General Hospital of IoanninaRecruiting
- IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori"Recruiting
- Ospedale San MartinoRecruiting
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoRecruiting
- Fondazione IRCCS San Gerardo dei Tintori
- ASST Santi Paolo e Carlo Ospedale San Carlo Borromeo SSD di Onco-Ematologia (Edificio C-piano terra)Recruiting
- Policlinico "G. Rodolico"Recruiting
- Azienda Ospedaliero Universitaria SeneseRecruiting
- IRCCS - AOU di BolognaRecruiting
- AOU Policlinico Umberto IRecruiting
- Fondazione Policlinico Universitario Agostino GemelliRecruiting
- Nagoya City University HospitalRecruiting
- Toyohashi Municipal HospitalRecruiting
- University of Fukui HospitalRecruiting
- National Hospital Organization Shibukawa Medical CenterRecruiting
- Iwate Medical University HospitalRecruiting
- Tohoku University HospitalRecruiting
- Hamamatsu University HospitalRecruiting
- Shizuoka Cancer CenterRecruiting
- Japanese Red Cross Medical CenterRecruiting
- Akita University HospitalRecruiting
- National Hospital Organization Kyushu Cancer CenterRecruiting
- Kyushu University HospitalRecruiting
- Kagoshima University HospitalRecruiting
- National Hospital Organization Kumamoto Medical CenterRecruiting
- Nagasaki University HospitalRecruiting
- National Hospital Organization Okayama Medical CenterRecruiting
- Osaka Metropolitan University HospitalRecruiting
- Tokushima University HospitalRecruiting
- Yamagata University HospitalRecruiting
- Seoul National University Bundang HospitalRecruiting
- Chonnam National University Hwasun HospitalRecruiting
- Pusan National University HospitalRecruiting
- Seoul National University HospitalRecruiting
- Samsung Medical CenterRecruiting
- The Catholic Univ. of Korea Seoul St. Mary's HospitalRecruiting
- Kyungpook National University HospitalRecruiting
- Kyungpook National University HospitalRecruiting
- Gachon University Gil Medical CenterRecruiting
- Asan Medical CenterRecruiting
- Hematológica Alta Especialidad SC, consultorio 830Recruiting
- Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
- Centro de Investigacion Clinica de OaxacaRecruiting
- Instituto Veracruzano en Investigación Clínica S.C.Recruiting
- Erasmus Universitair Medisch CentrumRecruiting
- Maastricht University Medical CenterRecruiting
- North Shore HospitalRecruiting
- North Shore HospitalRecruiting
- Aotearoa Clinical TrialsRecruiting
- Middlemore Clinical TrialsRecruiting
- Waikato HospitalRecruiting
- Palmerston North HospitalRecruiting
- Capital, Coast and Hutt Valley District - Wellington Regional HospitalRecruiting
- Haukeland UniversitetssjukehusRecruiting
- Stavanger UniversitetssykehusRecruiting
- Oslo Universitetssykehus UllevålRecruiting
- St Olavs HospitalRecruiting
- Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszczy Klinika HematologiiRecruiting
- Szpital Uniwersytecki nr 2 im. dr Jana Biziela w BydgoszczyRecruiting
- Uniwersyteckie Centrum KliniczneRecruiting
- Pratia Onkologia KatowiceRecruiting
- Szpital Kliniczny im. Heliodora Święcickiego UM w PoznaniuRecruiting
- Centrum Medyczne Pratia PoznanRecruiting
- Uniwersyteckie Centrum Kliniczne WUM Centralny Szpital KlinicznyRecruiting
- Klinika Hematologii, Nowotworow Krwi i Transplantacji SzpikuRecruiting
- Complejo Hospitalario Universitario de SantiagoRecruiting
- Institut Català d'Oncologia - L'HospitaletRecruiting
- Hospital Universitario Mutua TerrassaRecruiting
- Hospital Universitario Marqués de ValdecillaRecruiting
- Clinica Universidad de NavarraRecruiting
- Clinica Universidad de NavarraRecruiting
- Hospital Universitario de ToledoRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- Hospital Clinic BarcelonaRecruiting
- Hospital Universitario Reina SofíaRecruiting
- Hospital Universitari De Girona Doctor Josep TruetaRecruiting
- Hospital Universitario La PrincesaRecruiting
- Hospital Universitario Madrid SanchinarroRecruiting
- Hospital Universitario de SalamancaRecruiting
- Hospital Universitario Virgen Del RocioRecruiting
- Hospital Universitario y Politecnico La FeRecruiting
- Helsingborgs LasarettRecruiting
- Skånes Universitetssjukhus LundRecruiting
- Södra Älvsborg SjukhusRecruiting
- Falu LasarettRecruiting
- Sahlgrenska UniversitetssjukhusetRecruiting
- Sunderby SjukhusRecruiting
- Universitetssjukhuset ÖrebroRecruiting
- Universitetssjukhuset i LinköpingRecruiting
- Chang Gung Memorial Hospital at KaohsiungRecruiting
- China Medical University HospitalRecruiting
- National Cheng Kung University HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- Sisli Florence Nightingale HastanesiRecruiting
- Istanbul Universitesi Istanbul Tıp Fakultesi HastanesiRecruiting
- Medipol Mega Universite HastanesiRecruiting
- Acibadem Universitesi Atakent HastanesiRecruiting
- Ege Universitesi HastanesiRecruiting
- Dokuz Eylul Universitesi HastanesiRecruiting
- Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma MerkeziRecruiting
- Ankara Universitesi Tip Fakultesi HastanesiRecruiting
- Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma HastanesiRecruiting
- Akdeniz Universitesi HastanesiRecruiting
- Aydın Adnan Menderes Universitesi HastanesiRecruiting
- Gaziantep Universitesi Sahinbey Arastirma ve Uygulama HastanesiRecruiting
- Erciyes Universitesi Tıp Fakultesi HastaneleriRecruiting
- Özel Anadolu Sağlık MerkeziRecruiting
- Inonu Universitesi Turgut Ozal Tıp MerkeziRecruiting
- Royal Bournemouth HospitalRecruiting
- Churchill HospitalRecruiting
- Churchill Hospital, Oxford University Hospitals NHS Foundation TrustRecruiting
- University Hospital of WalesRecruiting
- Bristol Haematology and Oncology CentreRecruiting
- Kent and Canterbury HospitalRecruiting
- The Christie NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Active Comparator
Experimental
Experimental
Part 1 Safety Lead-In Dose Escalation: Elranatamab + Daratumumab
Part 2 Randomized Arm A: Elranatamab
Part 2 Randomized Arm B: Elranatamab + Daratumumab
Part 2 Randomized Arm C: Daratumumab + Pomalidomide + Dexamethasone
Part 3 Randomized Arm D: Alternative Elranatamab dosing + Daratumumab
Part 3 Randomized Arm E: Elranatamab + Daratumumab