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Trial record 1 of 1 for:    gmi1271-230
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A Study to Determine the Efficacy, Safety and Pharmacokinetics of GMI-1271 as Adjunct to Standard of Care for the Treatment of Multiple Myeloma

This study is currently recruiting participants.
See Contacts and Locations
Verified February 2017 by GlycoMimetics Incorporated
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated
ClinicalTrials.gov Identifier:
NCT02811822
First received: June 20, 2016
Last updated: February 8, 2017
Last verified: February 2017
  Purpose
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.

Condition Intervention Phase
Multiple Myeloma Drug: GMI-1271 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by GlycoMimetics Incorporated:

Primary Outcome Measures:
  • Safety assessed by frequency, severity and relatedness of AEs [ Time Frame: up to 6 months ]
    Assessed by frequency, severity and relatedness of AEs

  • Overall Response Rate [ Time Frame: up to 18 months ]
    Overall Response Rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response


Secondary Outcome Measures:
  • Clinical benefit rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response + Minimal Response + Stable Disease [ Time Frame: 18 months ]
  • Time to response [ Time Frame: 18 months ]
  • Time to progression [ Time Frame: 18 months ]
  • Duration of response [ Time Frame: 18 months ]
  • Progression free survival [ Time Frame: 18 months ]
  • Overall survival [ Time Frame: 18 months ]
  • Time versus plasma concentration profile of GMI-1271 [ Time Frame: up to Day 23 of Cycle 1 (each cycle is 21 or 28 days) ]

Estimated Enrollment: 48
Actual Study Start Date: June 2016
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose 1 Drug: GMI-1271
Experimental: Dose 2 Drug: GMI-1271
Experimental: Dose 3 Drug: GMI-1271
Experimental: Dose 4 Drug: GMI-1271

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02811822

Contacts
Contact: GlycoMimetics, Inc. clinicaltrials@glycomimetics.com

Locations
Ireland
Cork University Hospital, Wilton Recruiting
Cork, Ireland
Contact: Debra O'Hare    +021 4920051      
Principal Investigator: Mary E Cahill, MD         
Beaumont Hospital Recruiting
Dublin, Ireland
Contact: Tara Kenny    +01 809 2080      
Principal Investigator: John Quinn, MB PhD         
National University Ireland - Galway Recruiting
Galway, Ireland
Contact: Jessica Walsh    +0915 44544      
Principal Investigator: Michael O'Dwyer, MD         
Sponsors and Collaborators
GlycoMimetics Incorporated
Investigators
Principal Investigator: Michael O'Dwyer, MD National University Ireland - Galway
  More Information

Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT02811822     History of Changes
Other Study ID Numbers: GMI-1271-230
Study First Received: June 20, 2016
Last Updated: February 8, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by GlycoMimetics Incorporated:
GMI-1271
bortezomib
carfilzomib
multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 23, 2017