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Clinical Trials in China / NCT05317416
Active, not recruiting Phase 3

Study With Elranatamab Versus Lenalidomide in Patients With Newly Diagnosed Multiple Myeloma After Transplant

NCT05317416 · tracked via the Priya Life Science China tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2022-03-25
Last updated
2026-04-16

Condition(s) studied

Multiple Myeloma

Investigational drug(s) / intervention(s)

Elranatamab →Lenalidomide →Lenalidomide →Elranatamab →

Elranatamab: BCMA-CD3 bispecific antibody

Lenalidomide: Immunomodulatory drug

Lenalidomide: Immunomodulatory drug

Elranatamab: BCMA-CD3 bispecific antibody

Study summary

The purpose of this study is to evaluate whether elranatamab monotherapy can provide clinical benefit compared to lenalidomide monotherapy (control) in participants with newly diagnosed multiple myeloma after undergoing autologous stem cell transplant. In Part 1 and Part 2 of the study, participants in the study will either receive elranatamab (arm A and C) as an injection under the skin at the study clinic or lenalidomide orally once daily at home (arm B). Participation in the study will be approximately five years

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of MM as defined according to IMWG criteria (Rajkumar, 2014) with measurable disease at diagnosis * Part 1 patients must be MRD positive, Part 2 patients can be MRD negative or MRD positive * History of induction therapy for newly diagnosed MM, followed by high dose therapy and autologous stem cell transplant. Randomization must occur within 120 days from the stem cell transplant. For participants who receive consolidation therapy after ASCT, randomization must occur within 60 days of consolidation and within 7 months from ASCT. * Partial Response or better according to IMWG criteria at the time of randomization * Must have an archival bone marrow aspirate sample(s) to identify the dominant malignant (index) clone by central laboratory NGS test (ClonoSEQ assay) that is used to track MRD status. This sample should preferably be collected before induction treatment (eg, at diagnosis) or before transplant. * ECOG performance status ≤1 * Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤ 1 * Not pregnant and willing to use contraception Exclusion Criteria: * Plasma cell leukemia * Amyloidosis, Waldenström's macroglobulinemia * POEMS syndrome * Known active CNS involvement or clinical signs of myelomatous meningeal involvement * Previous MM maintenance treatment * Prior treatment with BCMA targeted therapy * Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ * Active, uncontrolled bacterial, fungal, or viral infection, including (but not limited to) HBV, HCV, and known HIV or AIDS-related illness * Previous administration with an investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer)

Primary outcome measure(s)

Trial sites (209)

FacilityCityRegionStatus
Banner Gateway Medical Center Gilbert Arizona
Banner Gateway Medical Pavilion Gilbert Arizona
Banner MD Anderson Cancer Center Gilbert Arizona
Ronald Reagan UCLA Medical Center Los Angeles California
UCLA Department of Medicine - Hematology/Oncology Los Angeles California
UCLA Hematology/Oncology Los Angeles California
Santa Monica UCLA Medical Center & Orthopaedic Hospital Santa Monica California
UCLA Hematology/Oncology - Santa Monica Santa Monica California
Georgetown University Medical Center Washington D.C. District of Columbia
Miami Cancer Institute at Baptist Health, Inc. Miami Florida
Winship Cancer Institute, Emory University Atlanta Georgia
Loyola University Chicago Maywood Illinois
Ascentist Doctor Hospital Leawood Kansas
University of Michigan Ann Arbor Michigan
American Oncology Partners, P.A. Dba MidAmerica Cancer Care Kansas City Missouri
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire
WMCHealth Advanced Physician Services Hawthorne New York
Westchester Medical Center Valhalla New York
Cleveland Clinic Cleveland Ohio
OhioHealth Arthur G.H. Bing, MD, Cancer Center Columbus Ohio
OhioHealth Research Institute Columbus Ohio
OhioHealth Riverside Methodist Hospital Columbus Ohio
Baylor University Medical Center Dallas Texas
Baylor Scott & White Medical Center - Temple Temple Texas
Royal Prince Alfred Hospital Camperdown New South Wales
Shoalhaven District Memorial Hospital Nowra New South Wales
Westmead Hospital Westmead New South Wales
Wollongong Hospital Wollongong New South Wales
Pindara Private Hospital Benowa Queensland
QScan Radiology Clinics Clayfield Queensland
Princess Alexandra Hospital Woolloongabba Queensland
Epworth Healthcare East Melbourne Victoria
Precision Haematology East Melbourne Victoria
St Vincent's Hospital (Melbourne) Fitzroy Victoria
Slade Pharmacy Richmond Australia
Medizinische Universität Wien Vienna Austria
Institut Jules Bordet Anderlecht Bruxelles-capitale, Région de
Grand Hôpital de Charleroi Charleroi Hainaut
Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi Yvoir Namur
UZ Gent Ghent Oost-vlaanderen

+ 169 more sites — see the full list on the official registry below.

On this site

📄 Revlimid (lenalidomide) drug profile →

More Pfizer trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05317416 on ClinicalTrials.gov ↗ ← All trials in China