Relapsed or Refractory Multiple MyelomaPhase 3NCT07623798
A Study in Participants With Relapsed or Refractory Multiple Myeloma for IBI3003
A Phase 3 study testing Pomalidomide Capsules, Bortezomib for Injection and Daratumumab Injection (Subcutaneous Injection) in people with Relapsed or Refractory Multiple Myeloma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed or Refractory Multiple Myeloma
- What is being tested?
- Pomalidomide Capsules, Bortezomib for Injection and Daratumumab Injection (Subcutaneous Injection)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 255 participants
- Where
- 1 siteChina
- Study dates
- 11 Jun 2026to 31 Dec 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
ZhongShan Hospital FuDan University
Shanghai, Shanghai Municipality, 132101
Peng Liu, 021-3115199, liu.peng@zs-hospital.sh.cn
About this study
Official title: 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)
Read the 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 or SVd) 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 or SVd). 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.
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Being tested
- Pomalidomide Capsules, Bortezomib for Injection, Daratumumab Injection (Subcutaneous Injection), IBI3003, Selinexor Tablets
- Medical subject headings
- Recurrence, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pomalidomide CapsulesDrug
Also called P
- 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;
Bortezomib for InjectionDrug
Also called V
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)Drug
Also called D
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.
IBI3003Drug
Also called trispecific antibody
According to body weight
Selinexor TabletsDrug
Also called S
The SVd treatment regimen, with one cycle every 35 days: Bortezomib on days 1, 8，15，22 and 29 ，100 mg/d orally.
| Study group | Role | What they receive |
|---|---|---|
| the investigator's choice regimen (DPd or PVd or SVd) | Active comparator | participants will receive DPd or PVd or SVd 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. Receives: Drug: Pomalidomide Capsules; Drug: Bortezomib for Injection; Drug: Daratumumab Injection (Subcutaneous Injection); Drug: Selinexor Tablets |
| IBI3003 | Experimental | 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. Receives: Drug: IBI3003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 24 months after the last enrolled participant receives the first dose of study drug
Secondary outcomes (19)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: up to 24 months after the last enrolled participant receives the first dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start11 Jun 2026
- Primary completion31 May 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 255 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07623798
- Sponsor's protocol ID
- CIBI3003A301
- Status last verified
- Sep 2026
- First submitted
- 21 May 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized Study Comparing IBI3003 Versus Treatment Per Investigator's Choice in Participants With Relapsed or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07623798
- Acronym / sponsor ID
- CIBI3003A301
- Conditions
- Relapsed or Refractory Multiple Myeloma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 255 participants (estimated)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jun 2026 (actual)
- Primary completion
- 31 May 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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 or SVd) 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 or SVd). 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the investigator's choice regimen (DPd or PVd or SVd) | Active comparator | Drug: Pomalidomide Capsules, Drug: Bortezomib for Injection, Drug: Daratumumab Injection (Subcutaneous Injection), Drug: Selinexor Tabletsparticipants will receive DPd or PVd or SVd 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. |
| IBI3003 | Experimental | Drug: IBI3003participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥18 years.
- Documented initial diagnosis of multiple myeloma according to IMWG diagnostic criteria.
- At least one of the following measurable disease indicators:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pomalidomide CapsulesAlso: P1. 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 | the investigator's choice regimen (DPd or PVd or SVd) |
| Bortezomib for InjectionAlso: VThe 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 | the investigator's choice regimen (DPd or PVd or SVd) |
| Daratumumab Injection (Subcutaneous Injection)Also: DThe 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 | the investigator's choice regimen (DPd or PVd or SVd) |
| IBI3003Also: trispecific antibodyAccording to body weight | Drug | IBI3003 |
| Selinexor TabletsAlso: SThe SVd treatment regimen, with one cycle every 35 days: Bortezomib on days 1, 8，15，22 and 29 ，100 mg/d orally. | Drug | the investigator's choice regimen (DPd or PVd or SVd) |
Primary outcome
PFS assessed by independent review committee
Time frame: 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
19 secondary outcomes
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
Overall survival
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug
Number of Participants with Serious Adverse Event (SAE)
Time frame: 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
Time frame: 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
Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pomalidomide Capsules, Bortezomib for Injection and Daratumumab Injection (Subcutaneous Injection) in people with Relapsed or Refractory Multiple Myeloma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haiyan Zhu (0512-69566088, haiyan.zhu@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS assessed by independent review committee (time frame: up to 24 months after the last enrolled participant receives the first dose of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.