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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02811822
• Other study ID #: GMI-1271-230
• Status: Completed
• Phase: Phase 1
• Start date: June 2016
• Est. completion date: April 2019

Study information

• Verified date: July 2019
• Source: GlycoMimetics Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• GMI-1271

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
GlycoMimetics Incorporated

Countries where clinical trial is conducted

Denmark,  Germany,  Ireland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by frequency, severity and relatedness of AEs	Assessed by frequency, severity and relatedness of AEs	up to 6 months
Primary	Overall Response Rate	Overall Response Rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response	up to 18 months
Secondary	Clinical benefit rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response + Minimal Response + Stable Disease		18 months
Secondary	Time to response		18 months
Secondary	Time to progression		18 months
Secondary	Duration of response		18 months
Secondary	Progression free survival		18 months
Secondary	Overall survival		18 months
Secondary	Time versus plasma concentration profile of GMI-1271		up to Day 23 of Cycle 1 (each cycle is 21 or 28 days)