BCMA × CD3 bispecific antibody · newly diagnosed multiple myeloma Phase III clinical trial
Official protocol title:A Phase III, Randomized Study Comparing Teclistamab in Combination With Subcutaneous (SC) Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With SC Daratumumab and Lenalidomide (Tal-DR) Versus SC Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma Not Eligible or Not Planned for Autologous Stem Cell Transplantation as Initial Therapy
Trial Summary
This project is a Phase III clinical trial sponsored by Johnson & Johnson (Janssen), primarily enrolling patients with newly diagnosed multiple myeloma (NDMM) who are not eligible or not planned to undergo autologous stem cell transplantation as initial therapy (first-line treatment, no prior treatment history required, and no specific gene mutation requirements). The treatment regimens evaluate the efficacy of a bispecific antibody (teclistamab or talquetamab) in combination with an anti-CD38 monoclonal antibody (daratumumab) and an immunomodulatory drug (lenalidomide) in first-line therapy, compared with the standard DRd regimen (daratumumab, lenalidomide, and the glucocorticoid dexamethasone). Treatment is administered in 28-day cycles continuously until disease progression. In China, the trial is conducted concurrently across 32 top domestic hospitals, including Tianjin Institute of Hematology (Blood Diseases Hospital, Chinese Academy of Medical Sciences), Peking Union Medical College Hospital, Beijing Chaoyang Hospital of Capital Medical University, Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, and Sun Yat-sen University Cancer Center, alongside 167 top international medical centers across 23 countries including Australia, France, Germany, Japan, and the United Kingdom.
Participating Centers1 in China + 31 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
- CTR20241434
- Verify on the NMPA CDE public platformby entering CTR20241434 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]. 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 15 inclusion and 21 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 (MajestTEC-7 study)]. 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 III] 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 1 study centres in China and 31 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, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Henan Cancer Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20241434] (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 III
Target / Therapy
BCMA × CD3 bispecific antibody (MajestTEC-7 study)
Sponsor
Johnson & Johnson (China) Investment Co., Ltd.
Principal Investigator
Lugui Qiu
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
1 in China + 31 overseas
CDE Registry ID
CTR20241434
Trial 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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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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