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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2019-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose 1

Group Type EXPERIMENTAL

GMI-1271

Intervention Type DRUG

Dose 2

Group Type EXPERIMENTAL

GMI-1271

Intervention Type DRUG

Dose 3

Group Type EXPERIMENTAL

GMI-1271

Intervention Type DRUG

Dose 4

Group Type EXPERIMENTAL

GMI-1271

Intervention Type DRUG

Interventions

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GMI-1271

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No