Antibody-drug conjugate targeting BCMA · relapsed/refractory multiple myeloma Phase III clinical trial
Official protocol title:A Phase III, Multicenter, Open-label, Randomized Study Evaluating the Efficacy and Safety of Belantamab Mafodotin in Combination with Pomalidomide and Dexamethasone (B-Pd) Versus Pomalidomide Plus Bortezomib and Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma (RRMM) (DREAMM 8)
Trial Summary
This project is a Phase III international multicenter clinical trial sponsored by GlaxoSmithKline (GSK), primarily targeting patients with relapsed/refractory multiple myeloma (RRMM) who have received at least 1 prior line of systemic therapy (which must include at least 2 consecutive cycles of lenalidomide) and had disease progression during or following the most recent therapy. In the experimental arm, the treatment regimen utilizes a BCMA-targeted antibody-drug conjugate (ADC) (belantamab mafodotin for injection) in combination with an immunomodulatory drug (pomalidomide) and a corticosteroid (dexamethasone); the control arm receives a proteasome inhibitor (bortezomib) in combination with pomalidomide and dexamethasone, administered predominantly in 21-day or 28-day repeating treatment cycles. This study is an international multicenter trial conducted concurrently across top medical centers in multiple countries worldwide. Domestically, it is currently underway at a total of 12 top key hospitals, including the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (Tianjin Hematology Institute), Peking University Third Hospital, Beijing Chaoyang Hospital, Sun Yat-sen University Cancer Center, and The First Affiliated Hospital, Zhejiang University School of Medicine.
Participating Centers1 in China + 10 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
- CTR20221556
- Verify on the NMPA CDE public platformby entering CTR20221556 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 8 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 [Antibody-drug conjugate (ADC) targeting BCMA]. 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 10 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, Sun Yat-sen University Cancer Center, Shengjing Hospital of China Medical University, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20221556] (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
Antibody-drug conjugate (ADC) targeting BCMA
Sponsor
GlaxoSmithKline (China) Investment Co., Ltd.
Principal Investigator
Weiwei Sui
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
1 in China + 10 overseas
CDE Registry ID
CTR20221556
Trial information is translated from the Chinese source record and reviewed by CMDN. Confirm current status and eligibility with the study team.
Where this study sits in the landscape
Browse comparable active studies by disease stage, modality and province
Keywords
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.
View CAR-T in China Guide →Evidence · Process · Costs · Verified hospitals
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.
Read application guide & patient rights