A Study in Participants With Relapsed or Refractory Multiple Myeloma for QLS4131
NCT07933432, Phase 3, Not yet recruiting, Qilu Pharmaceutical Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Study in Participants With Relapsed or Refractory Multiple Myeloma for QLS4131 | ClinicalTrials.gov |
| NCT number | NCT07933432 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 300 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Qilu Pharmaceutical Co., Ltd. | ClinicalTrials.gov |
| Conditions | Relapsed or Refractory Multiple Myeloma | ClinicalTrials.gov |
| Interventions | QLS4131, Pomalidomide Capsules, Bortezomib for Injection, Daratumumab Injection (Subcutaneous Injection), Dexamethasone | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | PFS assessed by independent review committee | up to 2 years 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 2016 response criteria. | ClinicalTrials.gov |
| Secondary | PFS assessed by investigator | up to 2 years 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 2016 response criteria. | ClinicalTrials.gov |
| Secondary | Very good partial response or better rate | up to 2 years after the last enrolled participant receives the first dose of study drug | 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 2016 response criteria. | ClinicalTrials.gov |
| Secondary | Negativity rate of minimal residual disease (MRD) | up to 2 years after the last enrolled participant receives the first dose of study drug | Defined as the proportion of participants achieving MRD-negative status. | ClinicalTrials.gov |
| Secondary | Sustained MRD negativity rate | up to 2 years after the last enrolled participant receives the first dose of study drug | Defined as the proportion of participants achieving MRD-negative status and maintaining it for at least 1 year. | ClinicalTrials.gov |
| Secondary | 6-month MRD negativity rate | up to 2 years after the last enrolled participant receives the first dose of study drug | The proportion of participants achieving a response of CR or better and MRD-negative status at 6 months post-randomization. | ClinicalTrials.gov |
| Secondary | 12-month MRD negativity rate | up to 2 years after the last enrolled participant receives the first dose of study drug | The proportion of participants achieving a response of CR or better and MRD-negative status at 12 months post-randomization. | ClinicalTrials.gov |
| Secondary | Objective response rate | up to 2 years after the last enrolled participant receives the first dose of study drug | 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 2016 response criteria. | ClinicalTrials.gov |
| Secondary | Complete response or better rate | up to 2 years after the last enrolled participant receives the first dose of study drug | 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 2016 response criteria. | ClinicalTrials.gov |
| Secondary | Duration of response | up to 2 years after the last enrolled participant receives the first dose of study drug | 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 2016 response criteria or death from any cause. | ClinicalTrials.gov |
| Secondary | PFS Rate at 6, 12, and 18 Months | 6, 12, and 18 months after randomization | Percentage of participants who remain alive and progression-free at 6, 12, and 18 months after randomization, as assessed by both the independent review committee (IRC) and the investigator according to IMWG 2016 response criteria. | ClinicalTrials.gov |
| Secondary | Overall survival | up to 2 years after the last enrolled participant receives the first dose of study drug | OS is defined as the time from the date of randomization to the date of the participant's death due to any cause. | ClinicalTrials.gov |
| Secondary | OS Rate at 12 and 24 Months | 12 and 24 months after randomization | Percentage of participants who remain alive at 12 and 24 months after randomization. | ClinicalTrials.gov |
| Secondary | Number of Participants with Treatment-Emergent Adverse events (TEAE) by Severity | up to 2 years after the last enrolled participant receives the first dose of study drug | Number of participants with AEs by Severity will be reported. | ClinicalTrials.gov |
| Secondary | Change from Baseline in Symptoms, Functioning, and Overall Health-related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC-QLQ-C30) | up to 2 years after the last enrolled participant receives the first dose of study drug | Change from baseline scores | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)