Pomalidomide CapsulesBortezomib for InjectionDaratumumab Injection (Subcutaneous Injection)IBI3003Selinexor Tablets
Pomalidomide Capsules: 1. The DPd treatment regimen, one cycle every 28 days: Pomalidomide 4mg/d orally, on days 1-21;
2. The PVd treatment regimen, one cycle every 21 days: Pomalidomide 4 mg/d orally, on days 1-14 of each treatment cycle;
Bortezomib for Injection: The PVd treatment regimen, with one cycle every 21 days: Bortezomib on days 1, 4, 8, and 11 of cycles 1-8, and on days 1 and 8 from cycle 9 onwards.
Daratumumab Injection (Subcutaneous Injection): The DPd treatment regimen, one cycle every 28 days: on days 1, 8, 15, and 22 of cycles 1 and 2; on days 1 and 15 from cycles 3-6; and on day 1 from cycle 7 onwards.
IBI3003: According to body weight
Selinexor Tablets: The SVd treatment regimen, with one cycle every 35 days: Bortezomib on days 1, 8，15，22 and 29 ，100 mg/d orally.
Study summary
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)
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria：
1. Age ≥18 years.
2. Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.
3. 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)
4. Life expectancy ≥3 months.
5. 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.
6. Willing and able to comply with the prohibitions and restrictions specified in this protocol.
Exclusion Criteria：
1. 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.
2. Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
3. 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.
4. Have history of primary immunodeficiency.
5. Have history of organ transplantation.
6. 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.
Primary outcome measure(s)
PFS assessed by independent review committee — up to 24 months after the last enrolled participant receives the first dose of study drug PFS is defined as the duration from the date of randomization to either PD or death, whichever comes first. Disease progression will be determined according to the IMWG response criteria
Trial sites (1)
Facility
City
Region
Status
ZhongShan Hospital FuDan University
Shanghai
Shanghai Municipality
Recruiting
More Innovent Biologics (Suzhou) Co. Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.