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NCT Number: NCT02811822

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 will evaluate GMI-1271, a specific E-selectin antagonist, in multiple myeloma as adjunct to standard of care chemotherapy used to treat this disease.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Vejle Hospital, Vejle, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

GMI-1271

Drug

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

GlycoMimetics Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 23, 2016
Registry last updated
Jul 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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