Trial · NCT05422027
Selinexor Plus VRd in High Risk Newly Diagnosed Multiple Myeloma
NCT05422027, Phase 1, Phase 2, Unknown, Xia Zhongjun
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Selinexor Plus VRd in High Risk Newly Diagnosed Multiple Myeloma. Trials, record NCT05422027. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05422027
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selinexor Plus VRd in High Risk Newly Diagnosed Multiple Myeloma
- NCT number
- NCT05422027
- Status
- Unknown
- Phases
- Phase 1, Phase 2
- Enrollment
- 42 participants, estimated
- Lead sponsor
- Xia Zhongjun
- Conditions
- Multiple Myeloma
- Interventions
- Selinexor, Bortezomib, Lenalidomide, Dexamethasone
- First posted
- 2022-06-16
- Last updated
- 2024-06-17
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose Escalation: Maximum Tolerated Dose (MTD) | Assessed from the date of first dose of study treatment to the first cycle ends (maximum 21days) ; | The MTD will be determined by study definition as the highest dose level without significant safety and tolerability concern. |
| Primary | Dose Escalation: Recommended Phase 2 Does (RP2D) | Assessed from the date of first dose of study treatment to the first cycle ends (maximum 21days) ; | The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for the dose expansion arms, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation portion of the study. |
| Primary | Dose Expansion: MRD negative remission | At any time up to 12 months after XVRD treatment | MRD negative remission (\<10-5) as defined by IMWG consensus |
| Secondary | complete response (CR) | Cycle 1 Day 1 (each cycle consists of maximum 21 days) until a VGPR, CR or PR (up to 12 cycles) | complete response (CR) and stringent complete response (sCR) |
| Secondary | Overall Survival (OS) | 12 months | Occurrence of death regardless of cause |
| Secondary | Progression-Free Survival (PFS) | 12 months | Duration from start of study treatment to PD or death (regardless of cause), whichever comes first |
| Secondary | Duration of Response (DOR) | 12 months | Duration from the first observation of at least PR to time of disease progression, or deaths due to disease progression, whichever occurs first |
| Secondary | Clinical Benefit Rate (CBR) | 12 months | Clinical Benefit Rate (CBR=ORR+Minor Response \[MR\]) |
| Secondary | Disease Control Rate (DCR) | 12 months | Disease Control Rate (DCR=CBR+Stable Disease\[SD; for a minimum of 12 weeks\]) |
| Secondary | Number of Participants with Adverse Events | From first dose of study drug administration to end of treatment (up to 12 months) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
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.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.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.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05422027
GET https://conductscience.org/api/trials/v1/NCT05422027/registered