Registered outcomes11

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

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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.
Other	Patient reported outcomes (PRO)	Up to 3 years	The PRO-Common Terminology Criteria for Adverse Events (CTCAE) will be incorporated to provide a better understanding of patient-reported symptomatic toxicity. PRO-CTCAE scores range from 0-4, with corresponding response choices for frequency (never / rarely / occasionally / frequently / almost constantly), for severity (none / mild / moderate / severe / very severe) and interference (not at all / a little bit / somewhat / quite a bit / very much). The scores for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. PRO-CTCAE data will be summarized descriptively as the number (%) of patients reporting each grade for individual items, and all available attribute items, will be included for each of the reported symptoms. The analyses will be exploratory and descriptive, and no statistical comparisons will be conducted. The relationship between refractory status and patient outcome will be explored.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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.

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