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

Phase 1

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: GMI-1271

• Registration Number: NCT02811822
• Lead Sponsor: GlycoMimetics Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-20
• Study First Submitted QC: 2016-06-21
• Study First Posted: 2016-06-23
• Primary Completion: 2019-04
• Study Completion: 2019-04
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-08
• Last Update Posted: 2019-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose 2	GMI-1271	-
Dose 3	GMI-1271	-
Dose 4	GMI-1271	-
Dose 1	GMI-1271	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Time to response	18 months
Time to progression	18 months
Duration of response	18 months
Clinical benefit rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response + Minimal Response + Stable Disease	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)

Trial Locations

Locations (8)

Saint James's University Hospital Leeds; 🇬🇧 Leeds, United Kingdom

Medizinische Klinik/Abt. Innere Medizin V; 🇩🇪 Heidelberg, Germany

Cork University Hospital, Wilton; 🇮🇪 Cork, Ireland

Vejle Hospital; 🇩🇰 Vejle, Denmark

National University Ireland - Galway; 🇮🇪 Galway, Ireland

Sheffield Teaching Hospital; 🇬🇧 Sheffield, England, United Kingdom

University College London Hospitals; 🇬🇧 London, United Kingdom

Beaumont Hospital; 🇮🇪 Dublin, Ireland