Trial · NCT04912427
Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease
NCT04912427, Phase 1, Terminated, Washington University School of Medicine
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease. Trials, record NCT04912427. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04912427
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease
- NCT number
- NCT04912427
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 1 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Multiple Myeloma
- Interventions
- Isatuximab, Bortezomib, Dexamethasone
- First posted
- 2021-06-03
- Last updated
- 2024-02-09
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04912427
GET https://conductscience.org/api/trials/v1/NCT04912427/registered