A Phase 3 interventional study of Pomalidomide Capsules and Bortezomib for Injection in Relapsed or Refractory Multiple Myeloma, sponsored by Innovent Biologics (Suzhou) Co. Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Innovent Biologics (Suzhou) Co. Ltd. (part of Innovent Biologics, Inc.) · Phase 3, Interventional, and Treatment
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)
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.
3,760 studies on the registry are indexed under Multiple Myeloma; 769 are open to participants now.
This study's planned enrollment of 255 is above the median of 41 across 3,005 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Innovent Biologics (Suzhou) Co. Ltd. is the lead sponsor of 199 studies on the registry; 46 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Compared within Multiple Myeloma, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Recurrence. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
At least one of the following indicators:
Exclusion Criteria：
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Pomalidomide Capsules · Drug: Bortezomib for Injection · Drug: Daratumumab Injection (Subcutaneous Injection) · Drug: Selinexor Tablets
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
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;
Also known as: P
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.
Also known as: V
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.
Also known as: D
According to body weight
Also known as: trispecific antibody
The SVd treatment regimen, with one cycle every 35 days: Bortezomib on days 1, 8，15，22 and 29 ，100 mg/d orally.
Also known as: S
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
Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug
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
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)
Defined as the proportion of participants achieving MRD-negative status
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
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
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
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
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
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
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)
Defined as the percentage of participants with 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
Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by EORTC-QLQ-C30 score will be reported
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
Percentage of participants with meaningful improvement in symptoms, functioning, and HRQoL as assessed by MySIm-Q score will be reported
Time frame: up to 24 months after the last enrolled participant receives the first dose of study drug
Started Jun 2026 (actual). Primary completion is estimated for May 2029, 35 months after the start.
Of 107 industry-sponsored phase 3 interventional studies under Multiple Myeloma, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 66. This study's planned 35 months is below that.
Counting every sponsor, half of 178 studies reached it within 56 months; a quarter within 35 and three quarters within 95.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: GPRC5D/BCMA/CD3-targeting T-cell Engager IBI3003
Innovent Biologics (Suzhou) Co. Ltd. →