A Study to Learn About the Effects of the Combination of Elranatamab, Daratumumab and Lenalidomide Compared With Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma Who Are Not Candidates for Transplant
AN OPEN-LABEL, 2-ARM, MULTICENTER, RANDOMIZED PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ELRANATAMAB (PF-06863135) + DARATUMUMAB + LENALIDOMIDE VERSUS DARATUMUMAB + BORTEZOMIB + LENALIDOMIDE + DEXAMETHASONE IN TRANSPLANT-INELIGIBLE PARTICIPANTS WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
- Multiple Myeloma
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Pfizer
- Enrolment target
- 1,060
- Started
- 10 November 2022
- Main results due
- 18 October 2030
- Study sites
- 160
- Registry updated
- 25 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: * Diagnosis of multiple myeloma (MM) 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 (Part 1) and ≥1 g/dL (Part 2); * 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 defined as: * Participants not considered candidates for high-dose chemotherapy and ASCT due to age or * Participants with important comorbidities likely to have a negative impact on tolerability of high dose chemotherapy and ASCT. * 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: * Smoldering Multiple Myeloma. * 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, total of 160 mg dexamethasone or equivalent before the first dose of study intervention). A cumulative dose of systemic corticosteroids equivalent to ≥20 mg of dexamethasone during screening. * 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.
What this study is about
In the sponsor’s own words, from the registry.
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, Bortezomib, Lenalidomide and Dexamethasone in people with newly diagnosed multiple myeloma.
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 rate of minimal residual disease (MRD) negative CR and the progression free survival (PFS) of the combination of elranatamab, daratumumab, and lenalidomide compared with the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone in participants with newly diagnosed multiple myeloma.
Study sites(160)
Jupiter Medical Center/Anderson Family Cancer Institute
Jupiter, Florida, United States
Recruiting
NHO Revive Research Institute, LLC
Lincoln, Nebraska, United States
Not yet recruiting
Renown Health Medical Oncology
Reno, Nevada, United States
Not yet recruiting
Renown Office of Clinical Research
Reno, Nevada, United States
Not yet recruiting
Renown Regional Medical Center
Reno, Nevada, United States
Not yet recruiting
MSK Basking Ridge
Basking Ridge, New Jersey, United States
Recruiting
MSK Monmouth
Middletown, New Jersey, United States
Recruiting
MSK Bergen
Montvale, New Jersey, United States
Recruiting
MSK Commack
Commack, New York, United States
Recruiting
MSK Westchester
Harrison, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street).
New York, New York, United States
Recruiting
Memorial Sloan Kettering Cancer Center-Main Campus
New York, New York, United States
Recruiting
MSK Nassau
Uniondale, New York, United States
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Recruiting
LDS Hospital
Salt Lake City, Utah, United States
Recruiting
Intermountain Cancer Center St. George
St. George, Utah, United States
Recruiting
St. George Regional Hospital
St. George, Utah, United States
Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Recruiting
Pindara Private Hospital
Benowa, Queensland, Australia
Recruiting
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Recruiting
Epworth Freemasons
Melbourne, Victoria, Australia
Recruiting
The Alfred Hospital
Melbourne, Victoria, Australia
Recruiting
Epworth Healthcare
Richmond, Victoria, Australia
Recruiting
Universitätsklinikum St. Pölten
Sankt Pölten, Lower Austria, Austria
Recruiting
Krankenhaus der Barmherzigen Schwestern Wien
Vienna, State of Vienna, Austria
Recruiting
Medizinische Universität Graz
Graz, Styria, Austria
Recruiting
Ordensklinikum Linz
Linz, Upper Austria, Austria
Not yet recruiting
Klinikum Wels-Grieskirchen GmbH
Wels, Upper Austria, Austria
Not yet recruiting
Landeskrankenhaus Feldkirch
Rankweil, Vorarlberg, Austria
Recruiting
Uniklinikum Salzburg
Salzburg, Austria
Recruiting
Medizinische Universität Wien
Vienna, Austria
Recruiting
Clinique Saint Pierre
Ottignies, Brabant Wallon, Belgium
Recruiting
UZ Brussel
Brussels, Bruxelles-capitale, Région de, Belgium
Not yet recruiting
Grand Hôpital de Charleroi
Gilly, Hainaut, Belgium
Recruiting
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi
Yvoir, Namur, Belgium
Recruiting
AZ Sint-Jan Brugge-Oostende AV
Bruges, West-vlaanderen, Belgium
Not yet recruiting
AZ Delta vzw
Roeselare, West-vlaanderen, Belgium
Recruiting
Centro Gaucho Integrado De Oncologia, Hematologia, Ensino E Pesquisa
Porto Alegre, Rio Grande do Sul, Brazil
Not yet recruiting
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (USP)
Ribeirão Preto, São Paulo, Brazil
Recruiting
Arthur J.E Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Not yet recruiting
Cross Cancer Institute
Edmonton, Alberta, Canada
Not yet recruiting
Dr. Everett Chalmers Regional Hospital
Fredericton, New Brunswick, Canada
Recruiting
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
Recruiting
Nova Scotia Health Authority
Halifax, Nova Scotia, Canada
Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, China
Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Recruiting
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Recruiting
Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Recruiting
The first hospital of jilin university
Changchun, Jilin, China
Recruiting
Tongji University - Shanghai Fourth People's Hospital
Shanghai, Shanghai Municipality, China
Recruiting
Institute of hematology&blood disease hospital
Tianjin, Tianjin Municipality, China
Recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Recruiting
The first Affiliated hospital of Wenzhou medical University
Wenzhou, Zhejiang, China
Recruiting
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, Czechia
Recruiting
Fakultni nemocnice Olomouc
Olomouc, Czechia
Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, Czechia
Recruiting
Showing 60 of 160 sites — filter to narrow it down. 140 of the 160 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05623020. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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