Trial · NCT04661137
Registered outcomes23
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 23
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) of patients receiving selinexor with carfilzomib and dexamethasone (Arm 1) | 30 Months | ORR will include patients who experience partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR), based on International Myeloma Working Group (IMWG) response criteria (Kumar 2016) |
| Primary | Overall Response Rate (ORR) of patients receiving selinexor with pomalidomide and dexamethasone (Arm 2) | 30 Months | ORR will include patients who experience partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR), based on International Myeloma Working Group (IMWG) response criteria (Kumar 2016) |
| Secondary | Progression Free Survival (PFS) | 30 Months | Duration from start of study treatment to PD or death \[regardless of cause\], whichever comes first |
| Secondary | Overall Survival (OS) | 30 Months | Duration from start of study treatment to death |
| Secondary | MRD Negativity | 30 Months | Rate of achievement of minimal residual disease (MRD) by multiparametric flow cytometry |
| Secondary | Incidence of Adverse Events [Safety and Tolerability] using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v 4.03. | 30 Months | Incidence of Adverse Events \[Safety and Tolerability\] using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), v 4.03. |
| Secondary | Time To Next Treatment (TTNT) | 30 Months | Duration from start of study treatment to next treament |
| Other | Overall Response Rate (ORR) of patients receiving selinexor with daratumumab and dexamethasone | 30 Months | ORR will include patients who experience partial response (PR), very good partial response (VGPR), complete response (CR), or stringent complete response (sCR), based on International Myeloma Working Group (IMWG) response criteria (Kumar 2016) |
| Other | Gut Microbiome analysis | 30 Months | To identify intestinal microbiota associated biomarkers that predict response and risk for development of treatment-related toxicities at baseline, on-treatment, post-treatment and relapse. |
| Other | Immune cell subset analyses | 30 Months | Changes from baseline in immune cell subsets in peripheral blood mononuclear and bone marrow mononuclear cells will be monitored. |
| Other | Analyses of cytokine markers | 30 Months | Cytokines will be quantified in plasma samples by multiplex ELISA and other readout assays. |
| Other | Analyses of chemokine markers | 30 Months | Chemokines will be quantified in plasma samples by multiplex ELISA and other readout assays. |
| Other | Analyses of inflammatory/anti-inflammatory markers | 30 Months | Inflammation/anti-inflammation markers will be quantified in plasma samples by multiplex ELISA and other readout assays. |
| Other | Analyses of bacterial translocation markers | 30 Months | Bacterial translocation markers will be quantified in plasma samples by multiplex ELISA and other readout assays. |
| Other | Basic peripheral blood laboratory variables: Lymphocytes | 30 Months | Basic peripheral blood laboratory value of absolute and relative lymphocytes obtained in routine clinical care will be evaluated prior to treatment, on-treatment, post-treatment, relapse and at development of severe AE (\>3 score). |
| Other | Basic peripheral blood laboratory variables: Eosinophils | 30 Months | Basic peripheral blood laboratory value of absolute and relative eosinophils obtained in routine clinical care will be evaluated prior to treatment, on-treatment, post-treatment, relapse and at development of severe AE (\>3 score). |
| Other | Basic peripheral blood laboratory variables: Monocytes | 30 Months | Basic peripheral blood laboratory value of absolute and relative monocytes obtained in routine clinical care will be evaluated prior to treatment, on-treatment, post-treatment, relapse and at development of severe AE (\>3 score). |
| Other | Basic peripheral blood laboratory variables: Neutrophils | 30 Months | Basic peripheral blood laboratory value of absolute and relative neutrophils obtained in routine clinical care will be evaluated prior to treatment, on-treatment, post-treatment, relapse and at development of severe AE (\>3 score). |
| Other | Basic peripheral blood laboratory variables: Basophils | 30 Months | Basic peripheral blood laboratory value of absolute and relative basophils obtained in routine clinical care will be evaluated prior to treatment, on-treatment, post-treatment, relapse and at development of severe AE (\>3 score). |
| Other | Basic peripheral blood laboratory variables: LDH | 30 Months | Basic peripheral blood laboratory value of LDH obtained in routine clinical care will be evaluated prior to treatment, on-treatment, post-treatment, relapse and at development of severe AE (\>3 score). |
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.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT04661137/registered