Trial · NCT04912427
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 | Safety and tolerability of the regimen as measured by the proportion of patients that discontinue therapy before Cycle 3 for toxicity or intolerance | Through completion of cycle 3 for all enrolled patients (estimated to be 39 months) | -Patients who discontinue therapy due to COVID-19 will not be included in the calculation of this proportion and will be replaced. Patients who discontinue therapy due to progressive disease before initiation of Cycle 3 will be replaced in the trial. |
| Secondary | Renal response per IMWG criteria | Through completion of treatment (estimated to be 6 months) | * Dialysis dependent at enrollment: * Conversion to dialysis independence: Return of renal function to where dialysis is not required for at least one consecutive month * Sustained dialysis independence: Return of renal function to where dialysis is not required for at least six consecutive months * Dialysis -independence at baseline or achieved while on therapy: * Complete response: Improved CrCl ≥ 60 mL/min * Partial response: In patients with baseline eGFR \< 15mL/min/1.73 m2, CrCl improved to 30 to 59 mL/min * Minor response: if baseline eGFR \< 15mL/min/1.73 m2, CrCl improved to 15 to 29 mL/min or if baseline eGFR 15 - 29 mL/min/1.73 m2, CrCl improved to 30 to 59 mL/min * Progressive renal disease: requirement of sustained |
| Secondary | Overall response rate (ORR) per IMWG criteria | Through completion of treatment (estimated to be 6 months) | -Partial response or better includes minimal residual disease (MRD) - negative, stringent complete response (sCR), complete response (CR), very good partial response (VGPR), and partial response per IMWG criteria |
| Secondary | Progression-free survival (PFS) | From cycle 1 day 1 through 5 years after completion of treatment (estimated to be 5 years and 6 months) | * PFS is defined as time from cycle 1 day 1 until progressive disease or death from any cause * Progressive disease is defined by IMWG Criteria |
| Secondary | Overall survival (OS) | From cycle 1 day 1 through 5 years after completion of treatment (estimated to be 5 years and 6 months) | -OS is defined as the time from cycle 1 day 1 until death from any cause |
| Secondary | Duration of response (DOR) | Through completion of treatment (estimated to be 6 months) | -DOR: for patients who achieve partial response or better, time from response was first noted until time of progressive disease; deaths due to causes other than progression are censored. |
| Secondary | Safety and tolerability of regimen as measured by discontinuation rate of each individual drug and duration/dose level exposure for each drug | Through completion of treatment (estimated to be 6 months) | |
| Secondary | Total number of adverse events | From start of treatment through 30 days after last day of treatment (estimated to be 7 months) | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting. |
| Secondary | Total number of treatment-emergent adverse events | From start of treatment through 30 days after last day of treatment (estimated to be 7 months) | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting. |
| Secondary | Total number of grade 3 or higher adverse events | From start of treatment through 30 days after last day of treatment (estimated to be 7 months) | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for all toxicity reporting. |
| Secondary | Change in quality of life as measured by the EORTC-QLQ 30 questionnaire | Baseline, end of cycle 1 (each cycle is 28 days), and end of cycle 3 (each cycle is 28 days) | The EORTC QLQ-C30 comprises 6 functional scales (role function, physical functioning, cognitive functioning, emotional functioning, social functioning and global quality of life) as well as nine symptom scales (fatigue, pain, nausea/vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). With the exception of 2 items included in the global health/quality of life scale, for which responses range from 1 (Very poor) to 7 (Excellent), item responses range from 1 (Not at all) to 4 (Very much). Raw scores for the EORTC QLQ-C30 are transformed to a 0-100 metric such that higher scores for all functional scales and Global Health Status indicate better quality of life; increase from baseline indicates improvement in quality of life compared to baseline. |
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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