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Trial · NCT04925193

Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma

NCT04925193, Phase 2, Active not recruiting, University of Colorado, Denver; results first posted 2026-03-06

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma. Trials, record NCT04925193. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04925193

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Personalized Selinexor-based Therapy for Relapsed/Refractory Multiple Myeloma
NCT number
NCT04925193
Status
Active not recruiting
Phases
Phase 2
Enrollment
18 participants, actual
Lead sponsor
University of Colorado, Denver
Conditions
Multiple Myeloma in Relapse
Interventions
Selinexor, Pomalidomide, Daratumumab, Carfilzomib, Dexamethasone
First posted
2021-06-14
Last updated
2026-10-02
Results first posted
2026-03-06

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryOverall Response RateOverall response rate was assessed from C1D1 through 30 days post last dose (approximately 10 months).To evaluate the overall response rate achieved with physician's choice selinexor-based combination therapy as measured by International Myeloma Working Group criteria (based on Kumar et al 2016).
SecondaryMRD Negative Response Rate2 years following End of Treatment or date of progression (whichever comes first), assessed up to 2 years
To evaluate the minimal residual disease negative response rate achieved with physician's choice selinexor-based combination therapy assessed via NGS or multiparametric flow cytometry with sensitivity of 10-5.
SecondaryProgression Free SurvivalFrom End of Treatment visit +2 years, or date of progression (whichever comes first), assessed up to 2 yearsTo evaluate the duration of progression free survival achieved with physician's choice selinexor-based combination therapy
SecondaryOverall SurvivalFrom study start date to study end date or death (whichever comes first), assessed up to 2 yearsTo evaluate the overall survival achieved with physician's choice selinexor-based combination therapy after 2 years off of study treatment.
SecondaryDuration of ResponseEnd of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 yearsTo evaluate the duration of response achieved with physician's choice selinexor-based combination therapy
SecondaryTime to Next TreatmentEnd of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 yearsTo evaluate the time to next treatment achieved with physician's choice selinexor-based combination therapy
SecondarySafety and Tolerability of Selinexor in Combination With Partner Backbone AgentsFrom first dose of study drug through 30 days after last dose of protocol required therapiesOccurrence, nature, and severity of adverse events

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYOverall Response RateEnd of Therapy, on average 10 monthsParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYMRD Negative Response Rate2 years following End of Treatment or date of progression (whichever comes first), assessed up to 2 yearsThe study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYProgression Free SurvivalEnd of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 years
The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually. This analysis was preplanned in the study protocol. Analysis of the secondary endpoint of progression free survival will be performed on the Intent-to-treat (ITT) population, which will include all subjects who have been enrolled for the study.
MonthsMEDIAN
SECONDARYOverall SurvivalEOT + 2 years, or date of progression (whichever comes first)
SECONDARYDuration of ResponseEnd of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 years
The study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually. This analysis was preplanned in the study protocol. Analysis of the secondary endpoint of duration of response will be performed on the Intent-to-treat (ITT) population, which will include all subjects who have been enrolled for the study.
MonthsMEDIAN
SECONDARYTime to Next TreatmentEnd of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 yearsThe study sample size was powered to analyze the total group of patients enrolled. It was not powered to analyze each treatment regimen individually.MonthsMEDIAN

Results by group15

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Overall Response RateArm 13Participants
Overall Response RateArm 24Participants
Overall Response RateArm 35Participants
MRD Negative Response RateGroup 10Participants
MRD Negative Response RateGroup 20Participants
MRD Negative Response RateGroup 32Participants
Progression Free SurvivalArm 17.695% Confidence Interval 2.8 to 12.4Months
Progression Free SurvivalArm 212.795% Confidence Interval 4.5 to 20.9Months
Progression Free SurvivalArm 317.295% Confidence Interval 3.2 to 31.2Months
Duration of ResponseGroup 13.0895% Confidence Interval 0.7 to 6.7Months

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDArm 13
Overall StudySTARTEDArm 26
Overall StudySTARTEDArm 39
Overall StudyCOMPLETEDArm 13
Overall StudyCOMPLETEDArm 26
Overall StudyCOMPLETEDArm 39
Overall StudyNOT COMPLETEDArm 10
Overall StudyNOT COMPLETEDArm 20
Overall StudyNOT COMPLETEDArm 30

Adverse events543

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherGeneral Disorders and Administration Site ConditionsGeneral disordersArm 1030
otherGeneral Disorders and Administration Site ConditionsGeneral disordersArm 2161
otherGeneral Disorders and Administration Site ConditionsGeneral disordersArm 3090
otherGeneral Disorders and Administration Site ConditionsGeneral disordersArm 1030
otherGeneral Disorders and Administration Site ConditionsGeneral disordersArm 2060
otherGeneral Disorders and Administration Site ConditionsGeneral disordersArm 3191
otherGeneral Disorders and Administration Site ConditionsGeneral disordersArm 1030
otherGeneral Disorders and Administration Site ConditionsGeneral disordersArm 2060
otherGeneral Disorders and Administration Site ConditionsGeneral disordersArm 3191
otherInfections and InfestationsInfections and infestationsArm 1030

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityArm 123
Total, all-cause mortalityArm 226
Total, all-cause mortalityArm 329
Total, other adverse eventsArm 133
Total, other adverse eventsArm 266
Total, other adverse eventsArm 399
Total, serious adverse eventsArm 103
Total, serious adverse eventsArm 226
Total, serious adverse eventsArm 349

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
P30CA046934University of Colorado Cancer Center Support GrantDEGREGORI, JAMES VUNIVERSITY OF COLORADO DENVERNATIONAL CANCER INSTITUTE1988 to 2025

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.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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/NCT04925193

GET https://conductscience.org/api/trials/v1/NCT04925193/events?page=2