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Trial record 2 of 14 for:    multiple myeloma and galway

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 : Recruiting
First Posted : June 23, 2016
Last Update Posted : May 3, 2018
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated

June 20, 2016
June 23, 2016
May 3, 2018
June 2016
August 2019   (Final data collection date for primary outcome measure)
  • 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
  • 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 12 months ]
    Overall Response Rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response
Complete list of historical versions of study NCT02811822 on ClinicalTrials.gov Archive Site
  • 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) ]
  • Clinical benefit rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response + Minimal Response + Stable Disease [ Time Frame: 12 months ]
  • Time to response [ Time Frame: 12 months ]
  • Time to progression [ Time Frame: 12 months ]
  • Duration of response [ Time Frame: 12 months ]
  • Progression free survival [ Time Frame: 12 months ]
  • Overall survival [ Time Frame: 12 months ]
  • Time versus plasma concentration profile of GMI-1271 [ Time Frame: up to Day 23 of Cycle 1 ]
Not Provided
Not Provided
 
A Study to Determine the Efficacy, Safety and Pharmacokinetics of GMI-1271 as Adjunct to Standard of Care for the Treatment of Multiple Myeloma
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Multiple Myeloma
Drug: GMI-1271
  • Experimental: Dose 1
    Intervention: Drug: GMI-1271
  • Experimental: Dose 2
    Intervention: Drug: GMI-1271
  • Experimental: Dose 3
    Intervention: Drug: GMI-1271
  • Experimental: Dose 4
    Intervention: Drug: GMI-1271
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
24
March 2021
August 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact: GlycoMimetics, Inc. clinicaltrials@glycomimetics.com
Denmark,   Germany,   Ireland,   United Kingdom
 
 
NCT02811822
GMI-1271-230
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
GlycoMimetics Incorporated
GlycoMimetics Incorporated
Not Provided
Principal Investigator: Michael O'Dwyer, MD National University Ireland - Galway
GlycoMimetics Incorporated
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP