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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02811822

Enrollment

Registered

2016-06-23

Start date

2016-06-30

Completion date

2019-04-30

Last updated

2019-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma

Keywords

GMI-1271, bortezomib, carfilzomib, multiple myeloma

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.

Interventions

DRUGGMI-1271

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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
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)
Progression free survival	18 months
Time to response	18 months

Countries

Denmark, Germany, Ireland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026