Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04083898 · ClinicalTrials.gov registry record · Phase 1
Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma
A Phase 1 study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- Phase 1
- Development phase
- 15
- Enrollment target
NCT04083898 is a Phase 1 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 15 participants.
The verdict
NCT04083898, a Phase 1 study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
Isatuximab targets and kills CD38-positive myeloma cells in manner similar to rituximab's mechanism of action on CD20-positive lymphoma cells. Based on the synergy between rituximab and bendamustine, as well as the established clinical efficacy of bendamustine and isatuximab as single agents for multiple myeloma, the logical next step is to combine isatuximab with bendamustine and prednisone. Due to lack of effective therapies in refractory multiple myeloma, herein the investigators propose studying this novel combination in this population, in order to address a significant unmet need. The aim of the investigators is to first determine the maximal tolerated dose of the combination in participants with relapsed/refractory myeloma and then to establish the efficacy of this novel combination.
Interventions
- DRUG Prednisone
- DRUG Bendamustine
- BIOLOGICAL Isatuximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2020-04-03 |
| Est. Completion | 2024-03-07 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04083898
The ClinicalTrials.gov registry entry for NCT04083898 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT04083898 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04083898 about?
NCT04083898 is a clinical study titled "Isatuximab, Bendamustine, and Prednisone in Refractory Multiple Myeloma". Isatuximab targets and kills CD38-positive myeloma cells in manner similar to rituximab's mechanism of action on CD20-positive lymphoma cells. Based on the synergy between rituximab and bendamustine, as well as the established clinical efficacy of bendamustine and isatuximab as single agents for mul...
What is the current status of trial NCT04083898?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2020-04-03. Estimated completion is 2024-03-07.
What interventions are being tested in trial NCT04083898?
The interventions under investigation include: Prednisone (DRUG), Bendamustine (DRUG), Isatuximab (BIOLOGICAL).
Who is sponsoring clinical trial NCT04083898?
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.