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

Running, not enrolling · Phase 3

Conditions studied: Multiple Myeloma

In brief

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

Key facts

Study ID

NCT05317416

Run by

Pfizer

People needed

854

Starts

2022-03-25

Expected to finish

2029-10-31

Last updated by the study team

2026-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Banner Gateway Medical Pavilion — Gilbert, Arizona, United States
• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States
• UCLA Department of Medicine - Hematology/Oncology — Los Angeles, California, United States
• UCLA Hematology/Oncology — Los Angeles, California, United States
• Santa Monica UCLA Medical Center & Orthopaedic Hospital — Santa Monica, California, United States
• UCLA Hematology/Oncology - Santa Monica — Santa Monica, California, United States
• Georgetown University Medical Center — Washington D.C., District of Columbia, United States
• Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States
• Winship Cancer Institute, Emory University — Atlanta, Georgia, United States
• Loyola University Chicago — Maywood, Illinois, United States
• Ascentist Doctor Hospital — Leawood, Kansas, United States
• University of Michigan — Ann Arbor, Michigan, United States
• American Oncology Partners, P.A. Dba MidAmerica Cancer Care — Kansas City, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• WMCHealth Advanced Physician Services — Hawthorne, New York, United States
• Westchester Medical Center — Valhalla, New York, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• OhioHealth Arthur G.H. Bing, MD, Cancer Center — Columbus, Ohio, United States
• OhioHealth Research Institute — Columbus, Ohio, United States
• OhioHealth Riverside Methodist Hospital — Columbus, Ohio, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Baylor Scott & White Medical Center - Temple — Temple, Texas, United States
• Royal Prince Alfred Hospital — Camperdown, New South Wales, Australia
• Banner Gateway Medical Center — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.