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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

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ClinicalTrials.gov Identifier: NCT02811822
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 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
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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



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) ]


Information from the National Library of Medicine

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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

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
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
Principal Investigator: Michael O'Dwyer, MD National University Ireland - Galway

Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT02811822     History of Changes
Other Study ID Numbers: GMI-1271-230
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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:
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