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

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Relapsed or Refractory Multiple Myeloma
• Intervention / Treatment: Drug: Pomalidomide Capsules; Drug: Bortezomib for Injection; Drug: Daratumumab Injection (Subcutaneous Injection); Drug: IBI3003

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.

• Study Type: Interventional
• Enrollment (Estimated): 255
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Haiyan Zhu; Phone Number: 0512-69566088; Email: haiyan.zhu@innoventbio.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 132101
      • ZhongShan Hospital FuDan University
      • Contact: Peng Liu; Phone Number: 021-3115199; Email: liu.peng@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: the investigator's choice regimen (DPd or PVd); participants will receive DPd or PVd until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.	Drug: Pomalidomide Capsules; The DPd treatment regimen, one cycle every 28 days: Pomalidomide 4mg/d orally, on days 1-21;; The PVd treatment regimen, one cycle every 21 days: Pomalidomide 4 mg/d orally, on days 1-14 of each treatment cycle; Other Names: P; 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.; Other Names: V; 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.; Other Names: D
Experimental: IBI3003; participants will receive IBI3003 until death, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent to participate in the study, or other reasons for discontinuation of study treatment, whichever occurs first.	Drug: IBI3003; According to body weight; Other Names: trispecific antibody

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS assessed by independent review committee	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	up to 24 months after the last enrolled participant receives the first dose of study drug

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS assessed by investigator	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	up to 24 months after the last enrolled participant receives the first dose of study drug
Negativity rate of minimal residual disease (MRD)	Defined as the proportion of participants achieving MRD-negative status	up to 24 months after the last enrolled participant receives the first dose of study drug
Sustained MRD negativity rate	Defined as the proportion of participants achieving MRD-negative status and maintaining it for at least 1 year	up to 24 months after the last enrolled participant receives the first dose of study drug
6-month MRD negativity rate.	The proportion of participants achieving a response of CR or better and MRD-negative status at 6 months post-randomization	up to 24 months after the last enrolled participant receives the first dose of study drug
12-month MRD negativity rate	The proportion of participants achieving a response of CR or better and MRD-negative status at 12 months post-randomization	up to 24 months after the last enrolled participant receives the first dose of study drug
Objective response rate	Objective response rate is defined as the percentage of participants who achieve PR or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria	up to 24 months after the last enrolled participant receives the first dose of study drug
Complete response or better rate	Complete response or better rate is defined as the percentage of participants who achieve CR or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria	up to 24 months after the last enrolled participant receives the first dose of study drug
Very good partial response or better rate	Very good partial response or better rate is defined as the percentage of participants who achieve very good partial response or better prior to subsequent antimyeloma therapy in accordance with the IMWG criteria	up to 24 months after the last enrolled participant receives the first dose of study drug
Duration of response	DoR is defined as the time interval between the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease according to the IMWG response criteria or death due to any cause, whichever occurs first	up to 24 months after the last enrolled participant receives the first dose of study drug
Time to response	Defined as the time from randomization to the date of the first tumor response assessment of PR or better among participants with a best overall response of PR or better	up to 24 months after the last enrolled participant receives the first dose of study drug
Time to best response	Defined as the time from randomization to the date of first documented Best Overall Response (BOR) among participants with a best overall response of PR or better	up to 24 months after the last enrolled participant receives the first dose of study drug
Time to next treatment	Defined as the time from initiation of study drug treatment to initiation of next-line therapy	up to 24 months after the last enrolled participant receives the first dose of study drug
Overall survival	OS is defined as the time from the date of randomization to the date of the participant's death due to any cause	up to 24 months after the last enrolled participant receives the first dose of study drug
Number of Participants with Treatment-Emergent Adverse events (TEAE) by Severity	Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grading of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) according to the ASTCT consensus	up to 24 months after the last enrolled participant receives the first dose of study drug
Number of Participants with Treatment-related Adverse Event (TRAE) by Severity	Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grading of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) according to the ASTCT consensus	up to 24 months after the last enrolled participant receives the first dose of study drug
Number of Participants with Adverse Event of Special Interest (AESI) by Severity	Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grading of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) according to the ASTCT consensus	up to 24 months after the last enrolled participant receives the first dose of study drug
Number of Participants with Serious Adverse Event (SAE)	Defined as the percentage of participants with SAE	up to 24 months after the last enrolled participant receives the first dose of study drug
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the EORTC-QLQ-C30 Scale Scores	Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported	up to 24 months after the last enrolled participant receives the first dose of study drug
Percentage of Participants With Meaningful Improvement in HRQoL, Symptoms and Functioning Using the MySIm-Q Scale Scores	Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by MySIm-Q score will be reported	up to 24 months after the last enrolled participant receives the first dose of study drug

Collaborators and Investigators

• Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: May 28, 2026
• First Posted (Actual): June 3, 2026

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Neoplasms; Disease Attributes; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Recurrence; Multiple Myeloma; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics; Drug Administration Routes; Drug Therapy; Inorganic Chemicals; Boronic Acids; Acids, Noncarboxylic; Acids; Boron Compounds; Pyrazines; Bortezomib; Injections; pomalidomide; daratumumab; Injections, Subcutaneous; Fumigant 93
• Other Study ID Numbers: CIBI3003A301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No