Small-molecule chemosensitizer · relapsed/refractory multiple myeloma Phase Ib/IIa clinical trial
Official protocol title:An Open-label, Parallel-controlled, Multicenter Phase Ib/IIa Clinical Study on the Efficacy and Safety of Puyistat Mesylate for Injection Combined with Pomalidomide Capsules and Low-Dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma
Trial Summary
This project is a Phase Ib/IIa clinical trial sponsored by Chengdu Zeling Biomedical Technology Co., Ltd., mainly targeting patients with relapsed/refractory multiple myeloma (RRMM) who have previously received at least one prior line of systemic anti-myeloma therapy (which must include lenalidomide and a proteasome inhibitor). The treatment regimen consists of Puyistat Mesylate for Injection (an HDAC inhibitor) in combination with pomalidomide capsules (an immunomodulatory agent) and low-dose dexamethasone acetate tablets (a glucocorticoid), administered in 21-day or 28-day treatment cycles. The trial is being conducted at 12 top domestic hospitals across China, including West China Hospital of Sichuan University, Peking University People's Hospital, The First Affiliated Hospital, Zhejiang University School of Medicine, Sun Yat-sen University Cancer Center, and Henan Cancer Hospital.
Participating Centers0 in China + 11 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
- CTR20241633
- Verify on the NMPA CDE public platformby entering CTR20241633 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 18–75 years, ECOG performance status ≤ 2, ≥ 1 prior lines of therapy. The study specifies 9 inclusion and 19 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 [Small-molecule chemosensitizer (HDAC inhibitor)]. 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 Ib/IIa] 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 0 study centres in China and 11 overseas centres. The lead institution is [West China Hospital of Sichuan University]. Prominent sites include West China Hospital of Sichuan University, Peking University People's Hospital, 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 [CTR20241633] (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 Ib/IIa
Target / Therapy
Small-molecule chemosensitizer (HDAC inhibitor)
Sponsor
Chengdu Zeling Biomedical Technology Co., Ltd.
Principal Investigator
Ting Niu
Lead Institution
West China Hospital of Sichuan University
Participating Centers
0 in China + 11 overseas
CDE Registry ID
CTR20241633
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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