Anti-CD38 monoclonal antibody · relapsed/refractory multiple myeloma Phase III clinical trial
Official protocol title:A Randomized, Double-Blind, Multicenter Phase III Clinical Study Comparing the Efficacy and Safety of QL2109 or DARZALEX FASPRO® in Combination with Pomalidomide and Dexamethasone, Respectively, in the Treatment of Patients with Relapsed/Refractory Multiple Myeloma (RRMM)
Trial Summary
This project is a phase III clinical trial sponsored by Qilu Pharmaceutical Co., Ltd., primarily targeting patients with relapsed/refractory multiple myeloma (RRMM) who have previously received at least 1 line of anti-myeloma therapy (including a proteasome inhibitor and lenalidomide, and those who have received only one prior line must be refractory to lenalidomide), and who have not previously received anti-CD38 monoclonal antibody and pomalidomide therapy. The treatment regimen comprises an anti-CD38 monoclonal antibody (QL2109 injection or daratumumab) in combination with an immunomodulatory drug (pomalidomide) and a glucocorticoid (dexamethasone), administered in 28-day cycles. The trial is being conducted at a total of 83 leading domestic hospitals in China, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Institute of Hematology), The First Affiliated Hospital, Zhejiang University School of Medicine, Peking University Third Hospital, Sun Yat-sen University Cancer Center, and Jiangsu Province Hospital.
Participating Centers1 in China + 82 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
- CTR20244775
- Verify on the NMPA CDE public platformby entering CTR20244775 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 [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, ≥ 1 prior lines of therapy. The study specifies 11 inclusion and 13 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 [Anti-CD38 monoclonal 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 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 82 overseas centres. The lead institution is [The First Affiliated Hospital, Zhejiang University School of Medicine]. Prominent sites include The First Affiliated Hospital, Zhejiang University School of Medicine, Henan Cancer Hospital, The Second Affiliated Hospital of Anhui Medical University, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20244775] (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
Anti-CD38 monoclonal antibody
Sponsor
Qilu Pharmaceutical Co., Ltd.
Principal Investigator
Zhen Cai
Lead Institution
The First Affiliated Hospital, Zhejiang University School of Medicine
Participating Centers
1 in China + 82 overseas
CDE Registry ID
CTR20244775
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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