Trial · NCT04764942
Selinexor, Pomalidomide, and Dexamethasone With or Without Carfilzomib for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, The SCOPE Trial
NCT04764942, Phase 1, Phase 2, Active not recruiting, Mayo Clinic
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Selinexor, Pomalidomide, and Dexamethasone With or Without Carfilzomib for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, The SCOPE Trial. Trials, record NCT04764942. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04764942
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Selinexor, Pomalidomide, and Dexamethasone With or Without Carfilzomib for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, The SCOPE Trial
- NCT number
- NCT04764942
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 39 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Recurrent Multiple Myeloma, Refractory Multiple Myeloma
- Interventions
Carfilzomib, Dexamethasone, Pomalidomide, Quality-of-Life Assessment, Questionnaire Administration, Selinexor, X-Ray Imaging, Computed Tomography, Positron Emission Tomography, Bone Marrow Biopsy, Bone Marrow Aspiration, Biospecimen Collection
- First posted
- 2021-02-21
- Last updated
- 2026-02-25
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose of selinexor in combination with carfilzomib, pomalidomide and dexamethasone (Phase I) | Up to 30 days after completion of treatment | A standard 3+3 phase I design will be utilized. Three patients will be treated at each dose level and observed for a minimum of four weeks (i.e. one full cycle) before new patients are treated. Doses will not be escalated in any individual patient. |
| Primary | Proportion of patients who achieve a confirmed response with selinexor in combination with pomalidomide and dexamethasone (Phase 2) | Up to 3 years | A confirmed response is defined as an stringent complete response (sCR), complete response (CR), very good \[partial response (VGPR), or partial response (PR) noted as the objective status on two consecutive evaluations. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. |
| Secondary | Duration of response | Up to 3 years | Defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be an sCR, CR, VGPR, or PR to the earliest date progression or relapse is documented. |
| Secondary | Clinical benefit rate | Up to 3 years | Will be estimated by the number of patients with an sCR, CR, VGPR, PR, or MR noted as the objective status on two consecutive evaluations divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated. |
| Secondary | Overall survival | From registration to death due to any cause, assessed up to 3 years | The distribution of overall survival will be estimated using the method of Kaplan-Meier |
| Secondary | Progression-free survival | From registration to the earliest date of documentation of disease progression, relapse, or death due to any cause, assessed up to 3 years | The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. |
| Secondary | Incidence of adverse events | Up to 3 years | The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. The number and severity of all adverse events (overall and by dose-level) will be tabulated and summarized in this patient population. The grade 3+ adverse events will also be described and summarized in a similar fashion. |
| Other | Relationship between risk groups | Up to 3 years | Patients will be categorized into different risk groups by cytogenetics and gene expression profiling. The relationship between risk groups and outcomes (confirmed response and progression-free survival) will be evaluated using Kruskal Wallace and log rank tests. |
| Other | Minimal residual disease (MRD) | Up to 3 years | Will be assessed on bone marrow aspirate in all patients achieving sCR or CR. The proportion of patients who achieve MRD negative status will be estimated by the number of patients who are MRD negative divided by the total number of evaluable patients who achieve an sCR or CR. Exact binomial 95% confidence intervals for the true MRD negative rate will be calculated. |
| Other | Overall health-related quality of life | Up to 18 cycles (each cycle is 28 days) | Will be assessed through patient self-reported instruments including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and Multiple Myeloma-20 instruments. High scores for the both global and functional domains indicate higher quality of life or functioning, while high scores on the symptom scales represent higher levels of symptomatology or problems. |
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/NCT04764942
GET https://conductscience.org/api/trials/v1/NCT04764942/registered