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

Sponsor

GlycoMimetics Incorporated (Industry)

Overall Status

Completed

CT.gov ID

NCT02811822

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

1.3

Patients Per Site

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Drug: GMI-1271	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 1, 2016

Actual Primary Completion Date :

Apr 1, 2019

Actual Study Completion Date :

Apr 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Safety assessed by frequency, severity and relatedness of AEs [up to 6 months]
Assessed by frequency, severity and relatedness of AEs
Overall Response Rate [up to 18 months]
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 [18 months]
Time to response [18 months]
Time to progression [18 months]
Duration of response [18 months]
Progression free survival [18 months]
Overall survival [18 months]
Time versus plasma concentration profile of GMI-1271 [up to Day 23 of Cycle 1 (each cycle is 21 or 28 days)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vejle Hospital	Vejle		Denmark
2	Medizinische Klinik/Abt. Innere Medizin V	Heidelberg		Germany
3	Cork University Hospital, Wilton	Cork		Ireland
4	Beaumont Hospital	Dublin		Ireland
5	National University Ireland - Galway	Galway		Ireland
6	Sheffield Teaching Hospital	Sheffield	England	United Kingdom
7	Saint James's University Hospital Leeds	Leeds		United Kingdom	LS9 7TF
8	University College London Hospitals	London		United Kingdom