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

Recruiting now · Phase 3

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT05623020

Run by

Pfizer

People needed

1116

Starts

2022-11-10

Expected to finish

2033-10-03

Last updated by the study team

2026-07-09

Who can join

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

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Nova Scotia Health Authority — Halifax, Nova Scotia, Canada (enrolling)
• Peking University Third Hospital — Beijing, Beijing Municipality, China (enrolling)
• Southern Medical University Nanfang Hospital — Guangzhou, Guangdong, China (enrolling)
• Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). — New York, New York, United States (enrolling)
• MSK Bergen — Montvale, New Jersey, United States (enrolling)
• QEII Health Sciences Centre — Halifax, Nova Scotia, Canada (enrolling)
• MSK Commack — Commack, New York, United States (enrolling)
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada (enrolling)
• MSK Monmouth — Middletown, New Jersey, United States (enrolling)
• Epworth Freemasons — Melbourne, Victoria, Australia (enrolling)
• The Alfred Hospital — Melbourne, Victoria, Australia (enrolling)
• Epworth Healthcare — Richmond, Victoria, Australia (enrolling)
• Medizinische Universität Graz — Graz, Styria, Austria (enrolling)
• Memorial Sloan Kettering Cancer Center-Main Campus — New York, New York, United States (enrolling)
• MSK Nassau — Uniondale, New York, United States (enrolling)
• MSK Basking Ridge — Basking Ridge, New Jersey, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Grand Hôpital de Charleroi — Gilly, Hainaut, Belgium (enrolling)
• AZ Delta vzw — Roeselare, West-vlaanderen, Belgium (enrolling)
• Pindara Private Hospital — Benowa, Queensland, Australia (enrolling)
• St Vincent's Hospital Melbourne — Fitzroy, Victoria, Australia (enrolling)
• MSK Westchester — Harrison, New York, United States (enrolling)
• Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)

Full record on ClinicalTrials.gov

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