NCT04682405

Uproleselan (GMI-1271) for GI Toxicity Prophylaxis During Melphalan-Conditioned Autologous Hematopoietic Cell Transplantation (Auto-HCT) for Multiple Myeloma (MM)

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
DRUG	Uproleselan	Provided by study
DRUG	Placebo	Provided by study
DRUG	Melphalan	-Standard of care

Timeline

• Start date: 2021-05-05
• Primary completion: 2022-11-11
• Completion: 2022-11-11
• First posted: 2020-12-23
• Last updated: 2023-12-15
• Results posted: 2023-12-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study