Compares IBI3003 with standard treatment in adults with relapsed or refractory multiple myeloma
Tests IBI3003 against standard drug combinations in adults with returned myeloma.
Plain-language title generated from the registry record
Registry title: A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
Where in China
- Zhongshan Hospital,Fudan UniversityShanghai, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Innovent Biologics (Suzhou) Co. Ltd.
- Trial code
- NCT07623798
- Record updated
- 17 September 2026
- Original description
The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd or SVd)Read full original descriptionShow less
A Phase 3 Randomized Study Comparing IBI3003 Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma
The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd or SVd)
Inclusion: Age ≥18 years; Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria; At least one of the following measurable disease indicators:; Serum M-protein ≥ 5 g/L（For IgA and IgD subtypes, it is recommended to use quantitative immunoglobulin measurements instead of M protein）; Urine M-protein ≥200 mg/24h; Serum free light chain (FLC) test: affected FLC level ≥100 mg/L and abnormal serum FLC ratio (<0.26 or >1.65); Life expectancy ≥3 months; Fertile females and sexually active fertile males must agree to use highly effective contraception (failure rate <1% per year) during the study and for 90 days after the last dose of the investigational drug. For participants in the clinical trial, contraceptive measures must comply with local regulations regarding the use of contraceptive methods. Females and males must agree not to donate eggs (ova, oocytes) or sperm during the study and for 90 days after the last dose of the investigational drug; Willing and able to comply with the prohibitions and restrictions specified in this protocol.
Exclusion: Previous treatment with any BCMA-targeted therapy and any GPRC5D-targeted therapy. Patients who have received either BCMA-targeted or GPRC5D-targeted therapy are allowed to participate in the study; Spinal cord compression that leads to limited self-care ability occurs within six months prior to informed consent or is expected to occur in the near future; Have received allogeneic hematopoietic stem cell transplantation within 6 months before the first administration of the study drug, or have received autologous stem cell transplantation within 3 months before the first administration of the study drug; Have history of primary immunodeficiency; Have history of organ transplantation; Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.