CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Uproleselan +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04682405
NCT04682405Phase 2Completed

A Phase II Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM)

Washington University School of Medicine·interventional·Posted Dec 23, 2020·Updated Dec 15, 2023

In Brief

A Phase 2 clinical trial evaluating Uproleselan, Placebo, and 1 other intervention for Multiple Myeloma. Completed, enrolled 51 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedDec 23, 2020
Enrollment StartMay 5, 2021
Primary CompletionNov 11, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.5 years ago

Interventions

Uproleselandrug

Provided by study

Placebodrug

Provided by study

Melphalandrug

-Standard of care