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NCT04682405 · ClinicalTrials.gov registry record · Phase 2
Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM)
A Phase 2 study of Multiple Myeloma, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT04682405: Completed Phase 2 study of Multiple Myeloma, sponsored by Washington University School of Medicine.
NCT04682405 is a Phase 2 study of Multiple Myeloma that has completed, run by Washington University School of Medicine. The registered enrollment target is 51 participants, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04682405, a Phase 2 study of Multiple Myeloma, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators hypothesize that prophylactic E-selectin inhibition via administration of uproleselan during melphalan conditioning will reduce the gastrointestinal (GI) toxicity in multiple myeloma (MM) patients undergoing auto-transplant, as assessed via diarrhea severity scoring per CTCAE v5.0, while potentially increasing chemosensitivity of malignant MM cells to high-dose melphalan.
Primary Outcome
Grade 0 is defined as no diarrhea, or no change from baseline. Grade 1 is defined as an increase of \<4 stools per day over baseline; mild increase in ostomy output compared to baseline. Grade 2 is defined as an increase of 4-6 stools per day over baseline; moderate increase in ostomy output compared to baseline; limiting instrumental ADL. Grade 3 is defined as an increase of \>=7 stools per day over baseline; hospitalization indicated; severe increase in ostomy output compared to baseline; limi
Conditions Studied
Interventions
- DRUG Melphalan
- DRUG Placebo
- DRUG Uproleselan
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2021-05-05 |
| Est. Completion | 2022-11-11 |
| Phase | Phase 2 |
What the finished NCT04682405 record still lists
NCT04682405 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 547-participant average among 438 other Multiple Myeloma trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Multiple Myeloma appearing as the primary indexed condition, and to 3 interventions - of which Melphalan is the first listed.
NCT04682405 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04682405 about?
NCT04682405 is a clinical study titled "Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM)". The investigators hypothesize that prophylactic E-selectin inhibition via administration of uproleselan during melphalan conditioning will reduce the gastrointestinal (GI) toxicity in multiple myeloma (MM) patients undergoing auto-transplant, as assessed via diarrhea severity scoring per CTCAE v5.0,...
What is the current status of trial NCT04682405?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2021-05-05. Estimated completion is 2022-11-11.
What conditions does trial NCT04682405 study?
This clinical trial studies the following conditions: Multiple Myeloma.
What interventions are being tested in trial NCT04682405?
The interventions under investigation include: Melphalan (DRUG), Placebo (DRUG), Uproleselan (DRUG).
Who is sponsoring clinical trial NCT04682405?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04682405 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Myeloma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04682405's enrollment target sits among peer trials
51 251st of 438 higher than 188 of 438 other Multiple Myeloma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Myeloma 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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