Spots Global Cancer Trial Database for A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
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Trial Identification
Brief Title: A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
Official Title: MAGNETISMM-6: 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 PARTICIPANTS WITH NEWLY-DIAGNOSED MULTIPLE MYELOMA
Study ID: NCT05623020
Conditions
Study Description
Brief 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 multiple myeloma. There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab when administered in combination with daratumumab and 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 transplant-ineligible multiple myeloma.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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 Hospital, Richmond, Victoria, Australia
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
Princess Margaret Cancer Centre, Toronto, Ontario, Canada
Fakultní nemocnice Brno Bohunice, Brno, Brno-město, Czechia
Fakultni nemocnice Ostrava, Ostrava, Moravskoslezský KRAJ, Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze, Praha 2, , 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-württemberg, Germany
Klinikum Chemnitz, Chemnitz, , Germany
Evangelismos General Hospital of Athens, Athens, Attikí, Greece
Alexandra General Hospital of Athens, Athens, Attikí, Greece
University Hospital of Ioannina, Ioannina, Ípeiros, Greece
Soroka Medical Center, Be'er Sheva, Hadarom, Israel
Rabin Medical Center, Petah-Tikva, Hamerkaz, Israel
The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric, Ramat Gan, Hamerkaz, Israel
Sourasky Medical Center, Tel Aviv, Tell Abīb, Israel
Hadassah Medical Center, Jerusalem, Yerushalayim, Israel
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
IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy
Fondazione IRCCS San Gerardo dei Tintori, Monza, Lombardia, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Piemonte, Italy
A.O.U. Policlinico Paolo Giaccone, Palermo, Sicilia, Italy
Azienda Ospedaliero Universitaria Pisana, Pisa, Toscana, Italy
Istituto Europeo di Oncologia IRCCS, Milano, , Italy
ASL PESCARA-Presidio Ospedaliero Pescara, Pescara, , Italy
AOU Policlinico Umberto I, Roma, , Italy
University of Fukui Hospital, Eiheiji-cho,Yoshida-gun, Fukui, Japan
University of Fukui Hospital, Yoshida-gun, Fukui, Japan
Gunma University Hospital, Maebashi, Gunma, Japan
Iwate Medical University Hospital, Shiwa-gun Yahaba-cho, Iwate, Japan
Iwate Medical University Hospital, Yahaba-cho, Shiwa-gun, Iwate, Japan
Tohoku University Hospital, Sendai-shi, Miyagi, Japan
Tohoku University Hospital, Sendai, Miyagi, Japan
Shizuoka Cancer Center, Nagaizumi-cho,Sunto-gun, Shizuoka, Japan
Japanese Red Cross Medical Center, Shibuya-ku, Tokyo, Japan
Kyushu University Hospital, Fukuoka, , Japan
National Hospital Organization Okayama Medical Center, Okayama, , Japan
National Hospital Organization Okayama Medical Center, Okayama, , Japan
Osaka Metropolitan University Hospital, Osaka, , Japan
Osaka Metropolitan University Hospital, Osaka, , Japan
Yamagata University Hospital, Yamagata, , Japan
Gachon University Gil Medical Center, Namdong-gu, Incheon-gwangyeoksi [incheon], Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun-gun, Jeonranamdo, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, Kyǒnggi-do, Korea, Republic of
Seoul National University Hospital, Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu, Wroclaw, Dolnośląskie, Poland
MTZ Clinical Research Powered by Pratia, Warszawa, Mazowieckie, Poland
Uniwersyteckie Centrum Kliniczne, Gdańsk, Pomorskie, Poland
Centrum Medyczne Pratia Poznań, Skorzewo, Wielkopolskie, Poland
Pratia Onkologia Katowice, Katowice, Śląskie, Poland
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, Navarra, 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
China Medical University Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch, Taoyuan, , Taiwan
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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