Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04912427 · ClinicalTrials.gov registry record · Phase 1
Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT04912427: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
NCT04912427 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 1 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04912427, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
This is a phase Ib study to assess the safety, tolerability, preliminary efficacy, and renal response of isatuximab, bortezomib, and dexamethasone in newly diagnosed multiple myeloma patients with severe renal impairment or dialysis-dependent end-stage renal disease. Such patients have limited therapeutic options due to renal clearance or nephrotoxicity of many myeloma therapies and are often excluded from clinical trials. Isatuximab in other regimens has shown efficacy and tolerability in patients with moderate renal impairment, although data are lacking for regimens containing CD38-targeting immunotherapies in severe renal impairment/ESRD.
Primary Outcome
-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.
Interventions
- DRUG Dexamethasone
- DRUG Isatuximab
- DRUG Bortezomib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2022-04-01 |
| Est. Completion | 2024-01-26 |
| Phase | Phase 1 |
Why NCT04912427 stopped before completion
NCT04912427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Dexamethasone is the first listed.
NCT04912427 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04912427 about?
NCT04912427 is a clinical study titled "Isatuximab, Velcade, and Dexamethasone in Patients With Multiple Myeloma and Severe KIDNEY Disease". This is a phase Ib study to assess the safety, tolerability, preliminary efficacy, and renal response of isatuximab, bortezomib, and dexamethasone in newly diagnosed multiple myeloma patients with severe renal impairment or dialysis-dependent end-stage renal disease. Such patients have limited thera...
What is the current status of trial NCT04912427?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2022-04-01. Estimated completion is 2024-01-26.
What interventions are being tested in trial NCT04912427?
The interventions under investigation include: Dexamethasone (DRUG), Isatuximab (DRUG), Bortezomib (DRUG).
Who is sponsoring clinical trial NCT04912427?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04912427's enrollment target sits among peer trials
1 2001st of 2000 the lowest of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI