Trial · NCT04756401
Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma
NCT04756401, Phase 2, Active not recruiting, Academic and Community Cancer Research United
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma. Trials, record NCT04756401. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04756401
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selinexor, Daratumumab, Carfilzomib and Dexamethasone for the Treatment of High-Risk, Recurrent or Refractory Multiple Myeloma
- NCT number
- NCT04756401
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- Academic and Community Cancer Research United
- Conditions
- Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
- Interventions
- Carfilzomib, Daratumumab, Dexamethasone, Quality-of-Life Assessment, Selinexor
- First posted
- 2021-02-16
- Last updated
- 2026-09-15
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Minimal Residual Disease (MRD) Negative Status | Up to 5 years post-treatment | MRD negative status at 10\^-5 level of sensitivity by flow cytometry will be considered synonymous with "success", unless specified otherwise. The proportion of success will be estimated by the number of success divided by the total number of evaluable patients. 95% confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. |
| Secondary | Overall Response Rate (ORR) | 2 years | Will be estimated by the total number of patients who achieve a confirmed response at any time divided by the total number of evaluable patients. A confirmed response is defined as a partial response (PR), very good partial response (VGPR), complete response (CR) or stringent complete response (sCR) noted as the objective status on two consecutive evaluations at least two weeks apart. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. The depth of response (PR versus VGPR versus CR versus sCR) will also be summarized. |
| Secondary | Time to Response | 2 years | Time to response (TTR) is defined as time from the date of registration to the date of confirmed response using IMWG criteria. TTR will be summarized descriptively (median, range). |
| Secondary | Duration of Response | 2 years | Duration of response (DOR) is defined as time from date at which the patient's confirmed objective status is noted to the earliest date of progression or death. The DOR will be estimated using the method of Kaplan-Meier. |
| Secondary | Progression-free Survival | 2 years | The progression free survival (PFS) is defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. The distribution of PFS will be estimated using method of Kaplan-Meier. |
| Secondary | Overall Survival (OS) | 2 years | The overall survival (OS) is defined as the time from registration to death due to any cause. The distribution of OS will be estimated using method of Kaplan-Meier. |
| Secondary | MRD Negativity Rate at 10^-6 of Sensitivity | 2 years | Will be assessed in the bone marrow by flow cytometry estimated as the number of patients who have achieved MRD negative result at 10\^-6 level of sensitivity at any time divided by the total number of evaluable patients. Exact 95% binomial confidence intervals for the true rate of MRD negative response will also be calculated. |
| Secondary | Number of Patients With a Grade 3 or Greater Adverse Event | 2 years | Will be assessed per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The number of patients with at least one grade 3 or greater AE, regardless of attribution, will be reported. |
| Other | Effect of Immunomodulatory Imide Drug-14 Scores Gene Expression Profile (GEP) on Progression-Free Survival | Baseline up to progression-free survival, assessed up to 5 years | The progression free survival (PFS) is defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. Patients will be categorized by their GEP and progression-free survival estimates will be compared across GEP scores. |
| Other | Change in EORTC QLQ-C30 Scores From Baseline to End of Treatment | Baseline up to progression, withdrawal, or end of treatment, assessed up to 5 years | QOL will be measured using the EORTC QLQ-C30, a patient-reported questionnaire about patient ability to function, symptoms related to the cancer and its treatment, overall health and quality of life, and perceived financial impact of the cancer and its treatment. Changes in raw score from baseline to end of treatment will be assessed, in each of the physical and mental health domains. The Wilcoxon signed-rank test will be utilized to assess changes in raw scores. Mean change, along with standard deviation will be reported. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
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.
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 |
|---|---|---|---|---|---|
| P30CA015083 | Mayo Clinic Comprehensive Cancer Center Support Grant | WILLMAN, CHERYL LYNN | MAYO CLINIC ROCHESTER | NATIONAL CANCER INSTITUTE | 1985 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/NCT04756401
GET https://conductscience.org/api/trials/v1/NCT04756401/registered