Trial · NCT07082270
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose limiting toxicities (DLTs) | Up to 28 days | As assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version (v) 5.0. The DLTs will be summarized by dose level using frequencies and relative frequencies. |
| Primary | Maximum tolerated dose (MTD) | Up to 28 days | Will determine the MTD of selvigaltin when administered in combination with daratumumab, carfilzomib, and dexamethasone (DaraKD). Will employ the Bayesian optimal interval design to find the MTD. |
| Primary | Recommended phase 2 dose (RP2D) | Up to 28 days | Will determine the RP2D of selvigaltin when administered in combination with DaraKD. The RP2D will be determined by evaluating both the toxicity profile and the therapeutic response. |
| Secondary | Incidence of overall adverse events | Up to 6 cycles (Cycle length = 28 days) | As assessed by the NCI CTCAE v5.0. |
| Secondary | Incidence of serious adverse events | Up to 6 cycles (Cycle length = 28 days) | As assessed by the NCI CTCAE v5.0. |
| Secondary | Overall response rate | During or after 6 cycles of therapy, assessed up to 3 years (Cycle length = 28 days) | As per investigator's assessment using the International Myeloma Working Group criteria will be summarized as proportions and 90% Clopper-Pearson confidence intervals by dose levels. |
| Secondary | Duration of response | During or after 6 cycles of therapy, assessed up to 3 years (Cycle length = 28 days) | |
| Secondary | Progression free survival | From the start of treatment until the first occurrence of disease progression or death from any cause, whichever comes first, assessed up to 3 years | Will be summarized using Kaplan-Meier estimators by dose levels. |
| Secondary | Overall survival | From the start of treatment to death from any cause, assessed up to 3 years | Will be summarized using Kaplan-Meier estimators by dose levels. |
| Secondary | Patient reported outcomes | At baseline, cycle 4 day 1, and 30 days after last dose of study drug | As assessed using the European Organization for the Research and Treatment of Cancer Quality of Life-Core 30 questionnaire. Will be summarized by dose levels and time points. Generalized linear mixed models will be used for within-subject comparisons between time points. |
| Secondary | Bone marrow measurable residual disease (MRD) status | After 6 cycles (Cycle length = 28 days) | The MRD status will be summarized as frequencies and relative frequencies by dose levels. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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/NCT07082270/registered