BCMA × CD3 bispecific antibody · newly diagnosed/relapsed/refractory multiple myeloma Phase 3 clinical trial
Official protocol title:An Open-Label, Two-Arm, Multicenter, Randomized, Phase 3 Study Evaluating the Efficacy and Safety of ELRANATAMAB (PF-06863135) + Daratumumab + Lenalidomide Versus Daratumumab + Lenalidomide + Dexamethasone in Study Participants with Transplant-Ineligible or Deferred Transplant Newly Diagnosed Multiple Myeloma
Trial Summary
This project is a phase 3 clinical trial sponsored by Pfizer, primarily targeting patients with transplant-ineligible or deferred transplant newly diagnosed multiple myeloma (NDMM), as well as a subset of patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–2 prior lines of therapy (including at least 1 immunomodulatory agent and 1 proteasome inhibitor). The treatment regimen evaluates a novel biologic (Elranatamab) combined with an anti-CD38 monoclonal antibody (daratumumab) and an immunomodulatory agent (lenalidomide), administered in 28-day cycles and continuing until disease progression or protocol-defined discontinuation criteria are met. The trial is being conducted across 12 key centers in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Blood Diseases Hospital), Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, The First Affiliated Hospital, Zhejiang University School of Medicine, Sun Yat-sen University Cancer Center, and The First Affiliated Hospital of Soochow University, and is running concurrently at 210 top international medical centers across 26 countries and regions including the United States, the United Kingdom, France, Germany, Canada, and Australia.
Participating Centers5 in China + 12 overseas
Source and Verification
Every fact on this page is derived from the official study protocol document below. The source document is archived as a PDF for direct verification.
- Document type
- CDE clinical trial registration filing (original PDF)
- Official registration number
- CTR20233883
- Verify on the NMPA CDE public platformby entering CTR20233883 in the registration-number field. The platform is a search interface with no permanent per-study URL, so a direct link is not possible.
- Last reconciled
- 2026-09-07
Frequently Asked Questions about this Study
Structured facts derived from official protocol filings for patient and family reference
According to official protocol filings (target population synthesized by CMDN from study details, not an official CDE field), this study is primarily designed for patients with [Newly diagnosed/Relapsed/refractory]. Eligibility requires verified clinical confirmation by investigators regarding prior lines of therapy, active disease biomarkers, and performance status.
According to verified protocol filings, key eligibility thresholds include: age ≥ 18 years, ECOG performance status ≤ 2, newly diagnosed patients (NDMM). The study specifies 7 inclusion and 15 exclusion criteria covering detailed organ function and medical history. Final enrollment confirmation is determined by investigators at participating hospital trial centers.
The core therapeutic target or investigational mechanism is [BCMA × CD3 bispecific antibody]. It aims to selectively eradicate clonal plasma cells or redirect anti-tumor immune responses, representing an active area of precision hematology research.
This study is registered as a [Phase 3] clinical trial. The protocol is conducted under rigorous ethical and Good Clinical Practice (GCP) oversight approved by institutional ethics committees.
This is an international multi-centre study with 5 study centres in China and 12 overseas centres. The lead institution is [Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences]. Prominent sites include Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, The First Affiliated Hospital, Zhejiang University School of Medicine, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20233883] (CDE_CTR). Patients and researchers can verify registration details and regulatory authorizations directly on the official NMPA CDE platform.
Key Information
Status
Recruiting
Phase
Phase 3
Target / Therapy
BCMA × CD3 bispecific antibody
Sponsor
Pfizer Investment Co., Ltd.
Principal Investigator
Lugui Qiu
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
5 in China + 12 overseas
CDE Registry ID
CTR20233883
ClinicalTrials.gov ID
NCT05020236Trial information is translated from the Chinese source record and reviewed by CMDN. Confirm current status and eligibility with the study team.
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Considering a non-trial option?
International participation must be confirmed directly with the study team. If a clinical trial is not practical, review our independent guide to CAR-T in China.
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Protocol drugs and related tests are fully covered by the sponsor. All studies are strictly supervised by ethics committees, and patients retain the legal right to withdraw at any time.
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