A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003

Official title

A Phase 3 Randomized Study Comparing IBI3003 Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma

Overview

The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd)

Detailed description

This study is an open, multicenter, randomized controlled phase III clinical trial aimed at evaluating the efficacy and safety of IBI3003 compared to the investigator's choice regimen (DPd or PVd) in participants with relapsed or refractory multiple myeloma who have previously received 1-4 lines of therapy and have been exposed to three classes of drugs (proteasome inhibitors, immunomodulators, and anti-CD38 monoclonal antibodies). The plan is to enroll approximately 255 participants, who will be randomly assigned to the experimental group and the control group in a 2:1 ratio. Approximately 170 participants in the experimental group will receive IBI3003 treatment, while about 85 participants in the control group will receive the investigator's choice of treatment (DPd or PVd). Participants in the experimental group can discontinue medication for observation after meeting the criteria for stopping treatment. During the discontinuation period, if they meet the re-treatment criteria, following discussion between the investigator and the sponsor, and based on the participant's preference, IBI3003 re-treatment may be given until the criteria for terminating treatment are met.

Interventions

• Drug 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;
• Drug 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.
• Drug 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.
• Drug IBI3003
  According to body weight

Primary outcome measures

• PFS assessed by independent review committee [Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug]

Secondary outcome measures (12)

• PFS assessed by investigator [Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug]
• Negativity rate of minimal residual disease (MRD) [Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug]
• Sustained MRD negativity rate [Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug]
• 6-month MRD negativity rate. [Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug]
• 12-month MRD negativity rate [Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug]
• Objective response rate [Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug]
• Complete response or better rate [Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug]
• Very good partial response or better rate [Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug]
• Duration of response [Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug]
• Time to response [Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug]
• Time to best response [Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug]
• Time to next treatment [Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug]

Eligibility criteria

Inclusion Criteria：

• 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 Criteria：

• 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.
• Known active CNS involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
• 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 history of primary immunodeficiency.
• Have history of organ transplantation.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 1 center

• ZhongShan Hospital FuDan University — Shanghai

Identifiers

NCT: NCT07623798 · CIBI3003A301

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗