Anti-CD38 monoclonal antibody · multiple myeloma Phase II clinical trial
Official protocol title:An International, Multicenter, Open-label, Treatment Extension Study in Patients With Multiple Myeloma Who Continue to Benefit From an Isatuximab-Based Treatment Following Completion of a Phase I, II, or III Parent Study
Trial Summary
This study is an international, multicenter, open-label, treatment extension clinical trial primarily for adult patients with multiple myeloma who have completed a relevant parent study and continue to benefit from isatuximab-based treatment. The primary objective of the study is to evaluate the long-term safety of isatuximab as monotherapy or combination regimens in patients previously treated with this drug. Participants will receive intravenous infusions of isatuximab once every two weeks or once every four weeks until discontinuation of study treatment. The trial is conducted at clinical centers across multiple countries and regions globally, including participating centers such as the Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences.
Participating Centers1 in China + 20 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
- CTR20231956
- Verify on the NMPA CDE public platformby entering CTR20231956 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
- 2026-09-21
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 [Multiple myeloma]. 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, acceptable performance status. The study specifies 5 inclusion and 7 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 II] 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 20 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, Royal North Shore Hospital, Instituto COI de Educacao e Pesquisa, among others. Eligible domestic patients can seek screening at the nearest participating centre.
The official public registration identifier for this protocol is [CTR20231956] (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 II
Target / Therapy
Anti-CD38 monoclonal antibody
Sponsor
Sanofi-Aventis Recherche & Développement / Sanofi (China) Investment Co., Ltd. / Sanofi-Aventis Deutschland GmbH
Principal Investigator
Junyuan Qi
Lead Institution
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Participating Centers
1 in China + 20 overseas
CDE Registry ID
CTR20231956
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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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.
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