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This is a randomized, double-blind, parallel-controlled, multicenter, phase III study to compare the efficacy and safety of HLX15-IV in combination with Rd (HLX15-IV-Rd) versus DARZALEX® in combination with Rd (D-Rd) in patients with NDMM who are ineligible for autologous stem cell transplantation (ASCT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLX15-IV-Rd | Experimental | HLX15-IV in combination with Lenalidomide-Dexamethasone (Rd) |
|
| DARZALEX-Rd | Active Comparator | DARZALEX in combination with Lenalidomide-Dexamethasone (Rd) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX15-IV | Drug | recombinant anti-CD38 human monoclonal antibody injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| IRC-assessed Week 24 rate of very good partial response (VGPR) or better | the percentage of patients achieving VGPR or CR (including sCR) until Week 24 after the date of randomization. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator-assessed Week 24 rate of VGPR or better | the percentage of patients achieving VGPR or CR (including sCR) until Week 24 after the date of randomization | 24 weeks |
| IRC- and investigator-assessed Week 12, 36 and 48 rate of VGPR or better |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan hospital, Shanghai | Shanghai | Shanghai Municipality | China |
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| Darzalex |
| Drug |
recombinant anti-CD38 human monoclonal antibody injection |
|
percentage of patients achieving VGPR or CR (including sCR) until Week 12, 36 and 48 after the date of randomization
| 12,36,48 weeks |
| IRC- and investigator-assessed partial response (PR) rate | the percentage of patients achieving PR at any time point after the date of randomization | 48 weeks |
| IRC- and investigator-assessed complete response (CR) rate | the percentage of patients achieving CR at any time point after the date of randomization. | 48 weeks |
| IRC- and investigator-assessed stringent complete response (sCR) rate | percentage of patients achieving sCR at any time point after the date of randomization | 48 weeks |
| IRC- and investigator-assessed complete response (CR) or better rate | the percentage of patients achieving CR or sCR at any time point after the date of randomization. | 48 weeks |
| IRC- and investigator-assessed overall response rate | the percentage of patients who achieve PR or better after the date of randomization. | 48 weeks |
| IRC- and investigator-assessed time to response (TTR) | the time from the date of randomization to the date of initial documentation of a response (PR or better) for patient who had achieved a response of PR or better | 48 weeks |
| IRC- and investigator-assessed duration of response (DOR) | the date of initial documentation of a response (PR or better) to either progressive disease according the IMWG criteria, or death, whichever occurs first | 48 weeks |
| IRC- and investigator-assessed progression free survival (PFS) | the duration from the date of randomization to either progressive disease, according to the IMWG response criteria, or death, whichever occurs first. | 48 weeks |
| Minimal residual disease (MRD) negative rate | the percentage of patients who achieve negative MRD at least once during the confirmed complete response (CR) or better according to the IMWG response criteria. | 48 weeks |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Health Status (EORTC-QLQ-C30). | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Health Status (EORTC-QLQ-C30).Minimum and maximum values is according to the items, the score range of item 1-28 is 1-4, the score range of item 29-30 is 1-7. The higher the overall score is, the better the overall quality of life is. | 48 weeks |
| EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire. | EuroQoL 5-Dimension 5-Level Health Status (EQ-5D-5L) Questionnaire.The description of health status is divided into five levels.Health Status Index range is -0.59-1.00, VAS range is 0-100.The higher the Health Status Index and VAS score are, the better the health condition is; the lower the dimension description score is, the fewer problems there are. | 48 weeks |
| Incidence and severity of adverse events (AEs) | severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] Version [v] 5.0, vital signs and clinical laboratory test results | 52 weeks |
| Time to reach maximum serum drug concentration at steady state (Tmax, ss) | Detailed Outcome Measure will be defined in the Statistical Analysis Plan | 48 weeks |
| Time to reach maximum serum drug concentration(Tmax) | Detailed Outcome Measure will be defined in the Statistical Analysis Plan | 48 weeks |
| Immunogenicity | Incidence of ADA and/or NAb for HLX15-IV and DARZALEX | 48 weeks |
| ID | Term |
|---|---|
| C556306 | daratumumab |
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