A Study to Determine the Efficacy, Safety and Pharmacokinetics of GMI-1271 as Adjunct to Standard of Care for the Treatment of Multiple Myeloma

A Phase I Open-Label Dose Escalation Study to Determine the Efficacy, Safety and Pharmacokinetics of GMI-1271 as Adjunct to Standard of Care Chemotherapy for the Treatment of Multiple Myeloma

This study will evaluate GMI-1271, a specific E-selectin antagonist, in multiple myeloma as adjunct to standard of care chemotherapy used to treat this disease.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: GMI-1271

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Vejle, Denmark
    • Vejle Hospital
• Germany
  • Heidelberg, Germany
    • Medizinische Klinik/Abt. Innere Medizin V
• Ireland
  • Cork, Ireland
    • Cork University Hospital, Wilton
  • Dublin, Ireland
    • Beaumont Hospital
  • Galway, Ireland
    • National University Ireland - Galway
• United Kingdom
  • Leeds, United Kingdom, LS9 7TF
    • Saint James's University Hospital Leeds
  • London, United Kingdom
    • University College London Hospitals
  • England
    • Sheffield, England, United Kingdom
      • Sheffield Teaching Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Males and females ≥ 18 years of age
2. Confirmed diagnosis of Multiple Myeloma
3. Subjects with progressive MM who have received at least 1 prior therapy and who have already undergone or are not expected to undergo hematopoietic stem cell transplantation
4. Subjects previously treated with an IMiD-based regimen or ineligible for an IMiD-based treatment regimen
5. Subjects must be receiving treatment with a proteasome inhibitor-based regimen (bortezomib-based or carfilzomib-based)
6. Adequate hepatic, renal, and cardiac function

Exclusion Criteria:

1. Intolerant to bortezomib or carfilzomib
2. Progressing evidence of end organ damage attributed to the underlying disease
3. Plasma cell leukemia
4. Congestive heart failure
5. Acute active infection
6. Non-hematologic malignancy within the past 3 years except: a) adequately treated basal cell or squamous cell skin cancer, b) carcinoma in situ of the cervix, or c) prostate cancer with stable PSA
7. Significant peripheral neuropathy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose 1	Drug: GMI-1271
Experimental: Dose 2	Drug: GMI-1271
Experimental: Dose 3	Drug: GMI-1271
Experimental: Dose 4	Drug: GMI-1271

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety assessed by frequency, severity and relatedness of AEs	Assessed by frequency, severity and relatedness of AEs	up to 6 months
Overall Response Rate	Overall Response Rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response	up to 18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	18 months
Duration of response	18 months
Time to progression	18 months
Progression free survival	18 months
Clinical benefit rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response + Minimal Response + Stable Disease	18 months
Time to response	18 months
Time versus plasma concentration profile of GMI-1271	up to Day 23 of Cycle 1 (each cycle is 21 or 28 days)

Collaborators and Investigators

• Sponsor: GlycoMimetics Incorporated
• Investigators: Principal Investigator: Michael O'Dwyer, MD, National University Ireland - Galway

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): April 1, 2019
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 21, 2016
• First Posted (Estimate): June 23, 2016

Study Record Updates

• Last Update Posted (Actual): July 10, 2019
• Last Update Submitted That Met QC Criteria: July 8, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: bortezomib; multiple myeloma; carfilzomib; GMI-1271
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: GMI-1271-230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No