Trial · NCT04843579
Treatment of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone for Relapsed Refractory Multiple Myeloma Patients
NCT04843579, Phase 2, Terminated, Weill Medical College of Cornell University; results first posted 2023-10-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone for Relapsed Refractory Multiple Myeloma Patients. Trials, record NCT04843579. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04843579
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Selinexor in Combination With Clarithromycin, Pomalidomide and Dexamethasone for Relapsed Refractory Multiple Myeloma Patients
- NCT number
- NCT04843579
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- Weill Medical College of Cornell University
- Conditions
- Myeloma Multiple, Myeloma, Refractory Multiple Myeloma
- Interventions
- Selinexor, Clarithromycin, Pomalidomide, Dexamethasone
- First posted
- 2021-04-13
- Last updated
- 2023-10-25
- Results first posted
- 2023-10-25
- Limitations and caveats
The statistical analysis plan (and associated statistical power) was based on an expected sample size of 26 participants. As only 4 participants enrolled, this reduced sample size was not sufficient for the statistical analysis plan as written, and, therefore, only descriptive statistics for the response proportions can be presented for the study.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Overall Response Rate of Partial Response or Better | Until disease progression; the maximum time any participant was followed for ORR was 287 days | ORR is defined as participants who experience a partial response, very good partial response, complete response, or stringent complete response per International Myeloma Working Group Criteria (IMWG) 2016 criteria. Complete Response is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates. Stringent Complete Response is defined as complete response as noted previously plus normal free light chain ratio and absence of clonal cells in bone marrow biopsy by immune-histochemistry. Partial Response is ≥50% reduction of serum M-protein plus reduction in 24 hour urinary M-protein by ≥90% or to \<200 mg per 24 h. Very Good Partial Response is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hr. |
| Secondary | Number of Participants With Adverse Events | Adverse events were collected from time of informed consent until 30 days after the last day of study drug administration for each participant. The maximum period that AEs were collected for a participant was 300 days. | Adverse events will be determined by Events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. The frequency of adverse events will be collected in tabular summary from when a participant consent to study until end of study or patient participant starts a new treatment. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Overall Response Rate of Partial Response or Better | Until disease progression; the maximum time any participant was followed for ORR was 287 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Adverse Events | Adverse events were collected from time of informed consent until 30 days after the last day of study drug administration for each participant. The maximum period that AEs were collected for a participant was 300 days. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Overall Response Rate of Partial Response or Better | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 2 | Participants | ||
| Number of Participants With Adverse Events | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 4 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 4 | |
| Overall Study | COMPLETED | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 2 | |
| Overall Study | NOT COMPLETED | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 2 |
Source ClinicalTrials.gov
Adverse events33
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 | Anemia | Blood and lymphatic system disorders | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 1 | 4 | |
| other | Anorexia | Metabolism and nutrition disorders | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 1 | 4 | |
| other | Blurred vision | Eye disorders | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 1 | 4 | |
| other | Concentration Impairment | Nervous system disorders | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 1 | 4 | |
| other | Confusion | Psychiatric disorders | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 1 | 4 | |
| other | Constipation | Gastrointestinal disorders | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 1 | 4 | |
| other | COVID-19 Infection | Infections and infestations | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 1 | 4 | |
| other | Dizziness | Nervous system disorders | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 2 | 4 | |
| other | Dysgeusia | Nervous system disorders | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 1 | 4 | |
| other | Dyspnea | Respiratory, thoracic and mediastinal disorders | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 1 | 4 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 0 | 4 |
| Total, other adverse events | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 4 | 4 |
| Total, serious adverse events | Selinexor, Clarithromycin, Pomalidomide and Dexamethasone (ClaSPd) | 1 | 4 |
Source ClinicalTrials.gov
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/NCT04843579
GET https://conductscience.org/api/trials/v1/NCT04843579/events?page=2