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

NCT04682405 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-12-15

Study results available
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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

Interventions

DRUG

Uproleselan

Provided by study

DRUG

Placebo

Provided by study

DRUG

Melphalan

-Standard of care

Sponsors & Collaborators

  • GlycoMimetics Incorporated

    collaborator INDUSTRY

  • The Foundation for Barnes-Jewish Hospital

    collaborator OTHER

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Keith Stockerl-Goldstein, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-05
Primary Completion
2022-11-11
Completion
2022-11-11
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04682405 on ClinicalTrials.gov