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

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 |
- 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
- 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) ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
Principal Investigator: | Michael O'Dwyer, MD | National University Ireland - Galway |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
GMI-1271 bortezomib carfilzomib multiple myeloma |
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 |