A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135), Daratumumab, Lenalidomide or Elranatamab and Lenalidomide Compared With Daratumumab, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
NCT ID: NCT05623020
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
966 participants
INTERVENTIONAL
2022-11-10
2031-11-29
Brief Summary
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There are 2 parts to this study. Part 1 will characterize the safety and tolerability of elranatamab in combination with daratumumab and lenalidomide or in combination with 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 or elranatamab and lenalidomide compared with the combination of daratumumab, lenalidomide, and dexamethasone in participants with newly diagnosed transplant-ineligible multiple myeloma.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Part 1, Dose Level 1: Elranatamab + Daratumumab + Lenalidomide
Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Daratumumab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Part 1, Multiple Dose Levels, Elranatamab + Daratumumab + Lenalidomide
Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Daratumumab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Part 2 Randomized Arm A: Elranatamab + Daratumumab + Lenalidomide
Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Daratumumab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Part 2 Randomized Arm B: Daratumumab + Lenalidomide + Dexamethasone
Daratumumab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Dexamethasone
Randomized
Part 1: Elranatamab + Lenalidomide
Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Part 2: Randomized Arm A: Elranatamab + Lenalidomide
Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Interventions
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Elranatamab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Daratumumab
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Lenalidomide
Part 1 Dose Level 1 is not randomized. All other cohorts are randomized.
Dexamethasone
Randomized
Eligibility Criteria
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Inclusion Criteria
* 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;
* Involved FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FLC ratio (\<0.26 or \>1.65).
* Part 1: Participants with relapsed/refractory multiple myeloma (RRMM) who have received 1-2 prior lines of therapy including at least one immunomodulatory drug and one proteasome inhibitor: or participants with newly-diagnosed multiple myeloma (NDMM) that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age \<65 years with comorbidities impacting the possibility of transplant.
* Part 2: participants with newly-diagnosed multiple myeloma that are transplant-ineligible as defined by age ≥65 years or transplant-ineligible as defined by age \<65 years with comorbidities impacting the possibility of transplant
* ECOG performance status ≤2.
* Not pregnant and willing to use contraception
* For participants with RRMM: Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1.
Exclusion Criteria
* Monoclonal gammopathy of undetermined significance.
* Waldenströms Macroglobulinemia
* Plasma cell leukemia.
* Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) COVID-19/SARS-CoV-2, HBV, HCV, and known HIV or AIDS-related illness.
* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, carcinoma in situ, or Stage 0/1 with minimal risk of recurrence per investigator.
* For participants with RRMM: Previous treatment with a BCMA-directed therapy or anti-CD38-directed therapy within 6 months preceding the first dose of study intervention in this study. Stem cell transplant ≤3 months prior to first dose of study intervention or active GVHD.
* For participants with NDMM: Previous systemic treatment for MM except for a short course of corticosteroids (ie, up to 4 days of 40 mg dexamethasone or equivalent before the first dose of study intervention).
* Live attenuated vaccine administered within 4 weeks of the first dose of study intervention.
* Administration of investigational product (eg, drug or vaccine) concurrent with study intervention or within 30 days (or as determined by the local requirement) preceding the first dose of study intervention used in this study.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality, China
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, Czechia
Fakultni nemocnice Ostrava
Ostrava, Moravskoslezský kraj, Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , 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-Wurttemberg, 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
Rabin Medical Center
Petah Tikva, Central District, Israel
The Edmond and Lily Safra Children's Hospital The Chaim Sheba Medical Center Department of Pediatric
Ramat Gan, Central District, Israel
Hadassah Medical Center
Jerusalem, Jerusalem, Israel
Soroka Medical Center
Beersheba, Southern District, Israel
Sourasky Medical Center
Tel Aviv, TELL ABĪB, 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
Cro-Irccs
Aviano, Friuli Venezia Giulia, Italy
Fondazione IRCCS San Gerardo dei Tintori
Monza, Lombardy, Italy
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy
A.O.U. Policlinico Paolo Giaccone
Palermo, Sicily, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
Bergamo, , Italy
Istituto Europeo di Oncologia IRCCS
Milan, , Italy
ASL PESCARA-Presidio Ospedaliero Pescara
Pescara, , Italy
Azienda Sanitaria Locale di Pescara
Pescara, , Italy
AOU Policlinico Umberto I
Roma, , Italy
University of Fukui Hospital
Yoshida-gun, Fukui, Japan
Gunma University Hospital
Maebashi, Gunma, Japan
Iwate Medical University Hospital
Yahaba-cho, Iwate, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Shizuoka, Japan
Japanese Red Cross Medical Center
Shibuya-ku, Tokyo, Japan
Kyushu University Hospital
Fukuoka, , Japan
National Hospital Organization Okayama Medical Center
Okayama, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Yamagata University Hospital
Yamagata, , Japan
Albert Schweitzer Ziekenhuis, locatie Dordwijk
Dordrecht, South Holland, Netherlands
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu
Wroclaw, Lower Silesian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Pratia Onkologia Katowice
Katowice, Silesian Voivodeship, Poland
Gachon University Gil Medical Center
Namdong-gu, Incheon-gwangyeoksi [incheon], South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeonranamdo, South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea
Seoul National University Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [seoul], South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital(Seoul St. Mary's Hospital)
Seoul, Seoul-teukbyeolsi [seoul], South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [seoul], South Korea
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, Navarre, 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
Kantonsspital Winterthur
Winterthur, , Switzerland
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2021-000803-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-514139-50-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
MAGNETISMM-6
Identifier Type: OTHER
Identifier Source: secondary_id
C1071006
Identifier Type: -
Identifier Source: org_study_id