SKCD in Early Relapsed/Refractory Multiple Myeloma
NCT07931391, Phase 2, Recruiting, Beijing Chao Yang Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | SKCD in Early Relapsed/Refractory Multiple Myeloma | ClinicalTrials.gov |
| NCT number | NCT07931391 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 66 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beijing Chao Yang Hospital | ClinicalTrials.gov |
| Conditions | Multiple Myeloma (MM) | ClinicalTrials.gov |
| Interventions | SKCD | ClinicalTrials.gov |
| First posted | 2026-11-12 | ClinicalTrials.gov |
| Last updated | 2026-11-12 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Best Complete Response or Better Rate (≥CR) | From enrollment to the end of treatment at 9 cycles (28 days per cycle) | The proportion of participants who achieve a confirmed complete response (CR) or stringent complete response (sCR), according to the International Myeloma Working Group criteria, during the first nine cycles of SKCD treatment and before initiation of Kd maintenance therapy. | ClinicalTrials.gov |
| Secondary | Best Complete Response or Better Rate During SKCD and Kd Maintenance | From enrollment to the end of treatment at 9 cycles (28 days per cycle)]. | The proportion of participants whose best confirmed response is complete response (CR) or stringent complete response (sCR), assessed according to the International Myeloma Working Group criteria from the first dose of study treatment through SKCD treatment and subsequent Kd maintenance, before disease progression or initiation of a new anti-myeloma treatment, whichever occurs first. | ClinicalTrials.gov |
| Secondary | Overall Response Rate (ORR) | From enrollment to the end of treatment at 9 cycles (28 days per cycle) | The proportion of participants who achieve a partial response (PR) or better as their best response, assessed according to the International Myeloma Working Group (IMWG) response criteria. | ClinicalTrials.gov |
| Secondary | Very Good Partial Response or Better Rate (≥VGPR) | From enrollment to the end of treatment at 9 cycles (28 days per cycle) | The proportion of participants who achieve a very good partial response (VGPR), complete response (CR), or stringent complete response (sCR) as their best response, assessed according to the International Myeloma Working Group (IMWG) response criteria. | ClinicalTrials.gov |
| Secondary | Minimal Residual Disease (MRD) Negativity Rate by Next-Generation Flow Cytometry | From enrollment to the end of treatment at 9 cycles (28 days per cycle), during maintenance treatment | The proportion of participants who achieve minimal residual disease (MRD) negativity in bone marrow, assessed by next-generation flow cytometry (NGF) at a sensitivity of 10\^-5. Bone marrow MRD is assessed when a participant achieves a very good partial response (VGPR) or better. The proportion of participants who achieve MRD negativity among participants who undergo bone marrow MRD testing by next-generation flow cytometry at a sensitivity of 10\^-5. | ClinicalTrials.gov |
| Secondary | Progression-Free Survival (PFS) | From the first dose of study treatment until disease progression or death from any cause, assessed up to 36 months. | The time from the first dose of study treatment to the first documented disease progression, assessed according to the International Myeloma Working Group (IMWG) response criteria, or death from any cause, whichever occurs first. | ClinicalTrials.gov |
| Secondary | Overall Survival (OS) | From the first dose of study treatment until death for any cause, assessed up to 36 months. | The time from the first dose of study treatment to death from any cause. | ClinicalTrials.gov |
| Secondary | Incidence and Severity of Adverse Events | From signing of informed consent through the post-treatment safety visit 60 days after the final dose of study treatment. | Number and proportion of participants experiencing adverse events, serious adverse events, and adverse events leading to dose modification or treatment discontinuation. Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 6.0. | 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 3
The papers the trial lists on ClinicalTrials.gov.
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)