NCT02811822

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 multiple-myeloma

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_1 multiple-myeloma

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 23, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

July 10, 2019

Status Verified

July 1, 2019

Enrollment Period

2.8 years

First QC Date

June 20, 2016

Last Update Submit

July 8, 2019

Conditions

Multiple Myeloma

Keywords

GMI-1271bortezomibcarfilzomibmultiple myeloma

Outcome Measures

Primary Outcomes (2)

  • Safety assessed by frequency, severity and relatedness of AEs

    Assessed by frequency, severity and relatedness of AEs

    up to 6 months

  • Overall Response Rate

    Overall Response Rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response

    up to 18 months

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (4)

Dose 1

EXPERIMENTAL
Drug: GMI-1271

Dose 2

EXPERIMENTAL
Drug: GMI-1271

Dose 3

EXPERIMENTAL
Drug: GMI-1271

Dose 4

EXPERIMENTAL
Drug: GMI-1271

Interventions

GMI-1271DRUG
Dose 1Dose 2Dose 3Dose 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Vejle Hospital

Vejle, Denmark

Location

Medizinische Klinik/Abt. Innere Medizin V

Heidelberg, Germany

Location

Cork University Hospital, Wilton

Cork, Ireland

Location

Beaumont Hospital

Dublin, Ireland

Location

National University Ireland - Galway

Galway, Ireland

Location

Sheffield Teaching Hospital

Sheffield, England, United Kingdom

Location

Saint James's University Hospital Leeds

Leeds, LS9 7TF, United Kingdom

Location

University College London Hospitals

London, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

uproleselan

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Michael O'Dwyer, MD

    National University Ireland - Galway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 23, 2016

Study Start

June 1, 2016

Primary Completion

April 1, 2019

Study Completion

April 1, 2019

Last Updated

July 10, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)GB(3)IE(3)DK(1)