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

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
GMI-1271
Sponsored by
GlycoMimetics Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Myeloma focused on measuring GMI-1271, bortezomib, carfilzomib, multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vejle Hospital
  • Medizinische Klinik/Abt. Innere Medizin V
  • Cork University Hospital, Wilton
  • Beaumont Hospital
  • National University Ireland - Galway
  • Sheffield Teaching Hospital
  • Saint James's University Hospital Leeds
  • University College London Hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose 1

Dose 2

Dose 3

Dose 4

Arm Description

Outcomes

Primary Outcome Measures

Safety assessed by frequency, severity and relatedness of AEs
Assessed by frequency, severity and relatedness of AEs
Overall Response Rate
Overall Response Rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response

Secondary Outcome Measures

Clinical benefit rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response + Minimal Response + Stable Disease
Time to response
Time to progression
Duration of response
Progression free survival
Overall survival
Time versus plasma concentration profile of GMI-1271

Full Information

First Posted
June 20, 2016
Last Updated
July 8, 2019
Sponsor
GlycoMimetics Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02811822
Brief Title
A Study to Determine the Efficacy, Safety and Pharmacokinetics of GMI-1271 as Adjunct to Standard of Care for the Treatment of Multiple Myeloma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
June 2016 (Actual)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlycoMimetics Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
GMI-1271, bortezomib, carfilzomib, multiple myeloma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dose 1
Arm Type
Experimental
Arm Title
Dose 2
Arm Type
Experimental
Arm Title
Dose 3
Arm Type
Experimental
Arm Title
Dose 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GMI-1271
Primary Outcome Measure Information:
Title
Safety assessed by frequency, severity and relatedness of AEs
Description
Assessed by frequency, severity and relatedness of AEs
Time Frame
up to 6 months
Title
Overall Response Rate
Description
Overall Response Rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response
Time Frame
up to 18 months
Secondary Outcome Measure Information:
Title
Clinical benefit rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response + Minimal Response + Stable Disease
Time Frame
18 months
Title
Time to response
Time Frame
18 months
Title
Time to progression
Time Frame
18 months
Title
Duration of response
Time Frame
18 months
Title
Progression free survival
Time Frame
18 months
Title
Overall survival
Time Frame
18 months
Title
Time versus plasma concentration profile of GMI-1271
Time Frame
up to Day 23 of Cycle 1 (each cycle is 21 or 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and females ≥ 18 years of age Confirmed diagnosis of Multiple Myeloma 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 Subjects previously treated with an IMiD-based regimen or ineligible for an IMiD-based treatment regimen Subjects must be receiving treatment with a proteasome inhibitor-based regimen (bortezomib-based or carfilzomib-based) Adequate hepatic, renal, and cardiac function Exclusion Criteria: Intolerant to bortezomib or carfilzomib Progressing evidence of end organ damage attributed to the underlying disease Plasma cell leukemia Congestive heart failure Acute active infection 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 Significant peripheral neuropathy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael O'Dwyer, MD
Organizational Affiliation
National University Ireland - Galway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vejle Hospital
City
Vejle
Country
Denmark
Facility Name
Medizinische Klinik/Abt. Innere Medizin V
City
Heidelberg
Country
Germany
Facility Name
Cork University Hospital, Wilton
City
Cork
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
Country
Ireland
Facility Name
National University Ireland - Galway
City
Galway
Country
Ireland
Facility Name
Sheffield Teaching Hospital
City
Sheffield
State/Province
England
Country
United Kingdom
Facility Name
Saint James's University Hospital Leeds
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
University College London Hospitals
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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