Pomalidomide · relapsed/refractory multiple myeloma Phase III clinical trial
Official protocol title:An Open-Label, Single-Arm, Multicenter Clinical Trial Evaluating the Efficacy and Safety of Pomalidomide Capsules Combined with Low-Dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma
Trial Summary
This project is a phase III clinical trial sponsored by Changzhou Pharmaceutical Factory Co., Ltd., primarily enrolling patients with relapsed/refractory multiple myeloma (RRMM) who have previously received at least 2 lines of anti-myeloma therapy (prior therapy must include lenalidomide and a proteasome inhibitor, with no prior exposure to pomalidomide). The treatment regimen consists of an immunomodulatory drug (pomalidomide capsules) combined with a glucocorticoid (low-dose dexamethasone acetate), administered in 28-day treatment cycles (pomalidomide administered continuously for 21 days followed by 7 days off; dexamethasone administered on days 1, 8, 15, and 22 of each cycle). The trial is conducted nationwide across a total of 28 leading core domestic hospitals, including Beijing Chaoyang Hospital, Capital Medical University; Peking University Third Hospital; Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; Sun Yat-sen University Cancer Center; and Sir Run Run Shaw Hospital, Zhejiang University School of Medicine.
Participating Centers1 in China + 27 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
- CTR20230801
- Verify on the NMPA CDE public platformby entering CTR20230801 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, ≥ 2 prior lines of therapy. The study specifies 10 inclusion and 17 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 [Pomalidomide]. 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 27 overseas centres. The lead institution is [Beijing Chaoyang Hospital, Capital Medical University]. Prominent sites include Beijing Chaoyang Hospital, Capital Medical University, Puyang Oilfield General Hospital, Shangqiu First People's Hospital, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20230801] (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
Pomalidomide
Sponsor
Changzhou Pharmaceutical Factory Co., Ltd.
Principal Investigator
Wenming Chen
Lead Institution
Beijing Chaoyang Hospital, Capital Medical University
Participating Centers
1 in China + 27 overseas
CDE Registry ID
CTR20230801
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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