Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate how well IBI3003 works when compared with the investigator's choice regimen (DPd or PVd)
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the investigator's choice regimen (DPd or PVd) | Active Comparator | 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pomalidomide Capsules | Drug |
|
| 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 |
| 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 |
Not provided
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:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyan Zhu | Contact | 0512-69566088 | haiyan.zhu@innoventbio.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZhongShan Hospital FuDan University | Shanghai | Shanghai Municipality | 132101 | China |
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D054219 | Neoplasms, Plasma Cell |
Not provided
Not provided
| ID | Term |
|---|---|
| C467566 | pomalidomide |
| D000069286 | Bortezomib |
| D007267 | Injections |
| C556306 | daratumumab |
| D007279 | Injections, Subcutaneous |
| C007792 | Fumigant 93 |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Bortezomib for Injection | Drug | 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 | 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. |
|
|
| IBI3003 | Drug | According to body weight |
|
|
| 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 |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D001896 |
| Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |