A new treatment approach for relapsed or refractory multiple myeloma in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label Phase 3 trial comparing IBI3003 to the investigator's choice regimen (DPd, PVd, or SVd) in adults with relapsed or refractory multiple myeloma who have had 1–4 prior therapies and exposure to three drug classes. Approximately 255 participants will be randomized in a 2:1 ratio, with the experimental group receiving IBI3003 and re-treatment considered after stopping criteria are met. The study includes standard myeloma-directed agents (pomalidomide, bortezomib, daratumumab) in the regimens and allows for re-treatment with IBI3003 upon re-treatment criteria in discussion with investigators and sponsor. Safety and efficacy outcomes will guide comparisons between the experimental and control arms.

Why it matters

Who can join: the full rules

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.

Where it's running

• ZhongShan Hospital FuDan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Haiyan Zhu
• Email: haiyan.zhu@innoventbio.com
• Phone: 0512-69566088

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• AZD4045 in Relapsed or Refractory Multiple Myeloma

  This study tests AZD4045 alone and with daratumumab and aldesleukin in adults whose multiple myeloma has returned or stopped responding to treatment.

  Recruiting at 3 sites Phase 1/2 AstraZeneca · Duarte, California and 11 other locations · NCT07681596

• O&D-001 CAR‑T injection for relapsed or refractory multiple myeloma

  This trial will test a CAR‑T injection called O&D‑001 that targets BCMA and GPRC5D in adults with relapsed or refractory multiple myeloma who have had at least two prior therapies.

  Recruiting Phase 1 O&D BioTech Group CO., Limited · Guangzhou, Guangdong · NCT07369895

• F182112 given with other drugs for relapsed or refractory multiple myeloma

  This trial will test whether F182112, given with different drug regimens, helps people whose multiple myeloma has returned or stopped responding to prior treatments.

  Recruiting Phase 2 Shandong New Time Pharmaceutical Co., LTD · Tianjin · NCT07312188

• QLS32015 versus pomalidomide+dexamethasone or selinexor+dexamethasone for relapsed or refractory multiple myeloma

  This will see if QLS32015 alone controls disease and is safe compared with pomalidomide+dexamethasone or selinexor+dexamethasone in adults with relapsed or refractory multiple myeloma who have had at least three prior treatments.

  Recruiting Phase 3 Qilu Pharmaceutical Co., Ltd. · Tianjin, Tianjin Municipality · NCT07138209

• mRNA-2808 for relapsed or refractory multiple myeloma

  This will test whether mRNA-2808 is safe and tolerable for people with relapsed or refractory multiple myeloma who have already received standard therapies.

  Recruiting at 10 sites Phase 1/2 ModernaTX, Inc. · Birmingham, Alabama and 9 other locations · NCT07116616

• QLS32015 combination therapy for relapsed or refractory multiple myeloma

  This study will test whether the injected drug QLS32015 combined with approved myeloma medicines helps people whose multiple myeloma has come back or not responded to previous treatment.

  Recruiting Phase 2 Qilu Pharmaceutical Co., Ltd. · Tianjin · NCT07018050

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.