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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811822
Recruitment Status : Completed
First Posted : June 23, 2016
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: GMI-1271 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Actual Study Start Date : June 2016
Actual Primary Completion Date : April 2019
Actual Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Dose 1 Drug: GMI-1271
Experimental: Dose 2 Drug: GMI-1271
Experimental: Dose 3 Drug: GMI-1271
Experimental: Dose 4 Drug: GMI-1271


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

  2. 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 :
  1. Clinical benefit rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response + Minimal Response + Stable Disease [ Time Frame: 18 months ]
  2. Time to response [ Time Frame: 18 months ]
  3. Time to progression [ Time Frame: 18 months ]
  4. Duration of response [ Time Frame: 18 months ]
  5. Progression free survival [ Time Frame: 18 months ]
  6. Overall survival [ Time Frame: 18 months ]
  7. Time versus plasma concentration profile of GMI-1271 [ Time Frame: up to Day 23 of Cycle 1 (each cycle is 21 or 28 days) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811822


Locations
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Denmark
Vejle Hospital
Vejle, Denmark
Germany
Medizinische Klinik/Abt. Innere Medizin V
Heidelberg, Germany
Ireland
Cork University Hospital, Wilton
Cork, Ireland
Beaumont Hospital
Dublin, Ireland
National University Ireland - Galway
Galway, Ireland
United Kingdom
Sheffield Teaching Hospital
Sheffield, England, United Kingdom
Saint James's University Hospital Leeds
Leeds, United Kingdom, LS9 7TF
University College London Hospitals
London, United Kingdom
Sponsors and Collaborators
GlycoMimetics Incorporated
Investigators
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Principal Investigator: Michael O'Dwyer, MD National University Ireland - Galway
More Information
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Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT02811822    
Other Study ID Numbers: GMI-1271-230
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlycoMimetics Incorporated:
GMI-1271
bortezomib
carfilzomib
multiple myeloma
Additional relevant MeSH terms:
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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