Trial · NCT05514990
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose-limiting toxicities (DLTs) (Phase 1B) | During the 21 days of cycle 1 | Incidence of dose-limiting toxicities resulting from pelareorep (PELA) in combination with bortezomib-dexamethasone (BOR-D) and pembrolizumab will be assessed. Severity of Adverse Events (AEs) will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Primary | Incidence and severity of adverse events (AEs) (Phase 1B) | Up to 30 days following cessation of study intervention | Incidence and severity of adverse events (AEs) will be graded according to NCI CTCAE version 5.0, and changes in clinical laboratory parameters. |
| Primary | Overall response rate (ORR) (complete response [CR] + partial response [PR]) (Phase 2) | Up to 3 years | Overall response rate, complete response partial response per the International Myeloma Working Group (IMWG) Uniform Response Criteria for multiple myeloma (MM). |
| Secondary | ORR (CR + PR) (Phase 1B) | Up to 3 years | ORR (CR + PR) per the IMWG Uniform Response Criteria for MM |
| Secondary | Duration of response (DOR) (Phase 2) | Up to 3 years | Time from first documentation of response (PR or greater) to first documentation of progressive disease (PD) or death from any cause, whichever occurs first. |
| Secondary | Progression-free survival (PFS) (Phase 2) | Up to 3 years | Time from the date of first study treatment to the date of first documented Progressive Disease (PD), as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause, whichever occurs first. |
| Secondary | Overall survival (OS) (Phase 2) | Up to 3 years | Defined as the time from the first study treatment administration to death from any cause. |
| Secondary | Incidence of adverse events (Phase 2) | From the time of intervention allocation through 90 days following cessation of study intervention or 30 days following cessation of study intervention | Type, frequency, and severity of AEs, using the NCI CTCAE version 5.0. |
| Secondary | Severity of serious adverse events (Phase 2) | From the time of intervention allocation through 90 days following cessation of study intervention or 30 days following cessation of study intervention | Serious adverse events (SAEs), using the NCI CTCAE version 5.0. |
| Other | Changes in gene expression (Phase 1B, Phase 2) | Up to 3 years | Will identify biological changes between pre-treatment and on-treatment biopsies as defined by changes in gene expression within the tumor microenvironment (TME). |
| Other | Changes in the T cell repertoire within peripheral blood and the TME (Phase 1B, Phase 2) | Up to 3 years | Will compare changes in the T cell repertoire within peripheral blood and the TME between pre-treatment and on-treatment biopsies, examining the formation of novel clones and the expansion of existing clones. |
| Other | Changes in the expression of immune-related biomarkers (Phase 1B, Phase 2) | Up to 3 years | To examine changes in the expression of immune-related biomarkers between pre-treatment and on-treatment blood samples and biopsies such as changes in programmed death protein-1 (PD-1) and programmed death ligand-1 (PDL-1) expression by immunohistochemistry (IHC) and imaging mass cytometry. |
| Other | PELA in combination with different therapies (Phase 1B, Phase 2) | Up to 3 years | Will evaluate whether PELA in combination with different therapies induces changes in different immune blood markers between pre-treatment and on-treatment blood samples (e.g., peripheral blood mononuclear cells \[PBMCs\]-flow cytometry and flow mass cytometry). |
| Other | CD4 and CD8 T-cell reactivity (Phase 1B, Phase 2) | Up to 3 years | Will examine CD4 and CD8 T-cell reactivity toward antigens and other stimuli between pre-treatment and on-treatment bone marrow biopsies and peripheral blood. |
| Other | Number of effector T-cells and resting T-cells (Phase 1B, Phase 2) | Up to 3 years | Will evaluate the number of effector (interferon-gamma \[IFN-gamma\] and Granzyme B) T-cells and resting T-cells in pre-treatment and on-treatment bone marrow biopsies and peripheral blood samples. |
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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