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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate | Overall 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). |
| Secondary | MRD Negative Response Rate | 2 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. |
| Secondary | Progression Free Survival | From End of Treatment visit +2 years, or date of progression (whichever comes first), assessed up to 2 years | To evaluate the duration of progression free survival achieved with physician's choice selinexor-based combination therapy |
| Secondary | Overall Survival | From study start date to study end date or death (whichever comes first), assessed up to 2 years | To evaluate the overall survival achieved with physician's choice selinexor-based combination therapy after 2 years off of study treatment. |
| Secondary | Duration of Response | End of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 years | To evaluate the duration of response achieved with physician's choice selinexor-based combination therapy |
| Secondary | Time to Next Treatment | End of Treatment +2 years, or date of progression (whichever comes first), assessed up to 2 years | To evaluate the time to next treatment achieved with physician's choice selinexor-based combination therapy |
| Secondary | Safety and Tolerability of Selinexor in Combination With Partner Backbone Agents | From first dose of study drug through 30 days after last dose of protocol required therapies | Occurrence, nature, and severity of adverse events |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Response Rate | End of Therapy, on average 10 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | MRD Negative Response Rate | 2 years following End of Treatment 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival | End 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. | Months | MEDIAN |
| SECONDARY | Overall Survival | EOT + 2 years, or date of progression (whichever comes first) | |||
| SECONDARY | Duration of Response | End 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. | Months | MEDIAN |
| SECONDARY | Time to Next Treatment | End 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. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate | Arm 1 | 3 | Participants | ||
| Overall Response Rate | Arm 2 | 4 | Participants | ||
| Overall Response Rate | Arm 3 | 5 | Participants | ||
| MRD Negative Response Rate | Group 1 | 0 | Participants | ||
| MRD Negative Response Rate | Group 2 | 0 | Participants | ||
| MRD Negative Response Rate | Group 3 | 2 | Participants | ||
| Progression Free Survival | Arm 1 | 7.6 | 95% Confidence Interval 2.8 to 12.4 | Months | |
| Progression Free Survival | Arm 2 | 12.7 | 95% Confidence Interval 4.5 to 20.9 | Months | |
| Progression Free Survival | Arm 3 | 17.2 | 95% Confidence Interval 3.2 to 31.2 | Months | |
| Duration of Response | Group 1 | 3.08 | 95% Confidence Interval 0.7 to 6.7 | Months |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 | 3 | |
| Overall Study | STARTED | Arm 2 | 6 | |
| Overall Study | STARTED | Arm 3 | 9 | |
| Overall Study | COMPLETED | Arm 1 | 3 | |
| Overall Study | COMPLETED | Arm 2 | 6 | |
| Overall Study | COMPLETED | Arm 3 | 9 | |
| Overall Study | NOT COMPLETED | Arm 1 | 0 | |
| Overall Study | NOT COMPLETED | Arm 2 | 0 | |
| Overall Study | NOT COMPLETED | Arm 3 | 0 |
Source ClinicalTrials.gov
Adverse events543
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 |
|---|---|---|---|---|---|---|
| other | General Disorders and Administration Site Conditions | General disorders | Arm 1 | 0 | 3 | 0 |
| other | General Disorders and Administration Site Conditions | General disorders | Arm 2 | 1 | 6 | 1 |
| other | General Disorders and Administration Site Conditions | General disorders | Arm 3 | 0 | 9 | 0 |
| other | General Disorders and Administration Site Conditions | General disorders | Arm 1 | 0 | 3 | 0 |
| other | General Disorders and Administration Site Conditions | General disorders | Arm 2 | 0 | 6 | 0 |
| other | General Disorders and Administration Site Conditions | General disorders | Arm 3 | 1 | 9 | 1 |
| other | General Disorders and Administration Site Conditions | General disorders | Arm 1 | 0 | 3 | 0 |
| other | General Disorders and Administration Site Conditions | General disorders | Arm 2 | 0 | 6 | 0 |
| other | General Disorders and Administration Site Conditions | General disorders | Arm 3 | 1 | 9 | 1 |
| other | Infections and Infestations | Infections and infestations | Arm 1 | 0 | 3 | 0 |
1 to 10 of 543Source ClinicalTrials.gov
See all 543 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | 2 | 3 |
| Total, all-cause mortality | Arm 2 | 2 | 6 |
| Total, all-cause mortality | Arm 3 | 2 | 9 |
| Total, other adverse events | Arm 1 | 3 | 3 |
| Total, other adverse events | Arm 2 | 6 | 6 |
| Total, other adverse events | Arm 3 | 9 | 9 |
| Total, serious adverse events | Arm 1 | 0 | 3 |
| Total, serious adverse events | Arm 2 | 2 | 6 |
| Total, serious adverse events | Arm 3 | 4 | 9 |
Source ClinicalTrials.gov
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA046934 | University of Colorado Cancer Center Support Grant | DEGREGORI, JAMES V | UNIVERSITY OF COLORADO DENVER | NATIONAL CANCER INSTITUTE | 1988 to 2025 |
Source NIH RePORTER
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/NCT04925193
GET https://conductscience.org/api/trials/v1/NCT04925193/events?page=2