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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: Clinical Trial Phase 1 study, sponsored by Washington University School of Medicine.
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The maximum tolerated dose (MTD) is defined as the dose level immediately below the dose level at which 2 participants of a cohort (of 2 to 6 participants) experience dose limiting toxicity (DLT) during the first cycle of treatment. Dose escalation will proceed until the MTD has been reached or until the maximum dose of each drug is tested (Dose Level 3). If no more than 1 DLT is observed at dose levels 1, 2 and 3, level 3 will be declared the recommended phase II dose (RP2D) and the MTD will re
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 |
Why NCT04083898 stopped before completion
NCT04083898 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT04083898 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT04083898's enrollment target sits among peer trials
15 1798th of 2000 higher than 157 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
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