Multiple MyelomaPhase 1NCT02811822
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 1 study testing GMI-1271 in people with Multiple Myeloma, run by GlycoMimetics Incorporated at 8 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- GMI-1271
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Jun 2016to Apr 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
Ireland3 sites
Cork University Hospital, Wilton
Cork
Beaumont Hospital
Dublin
National University Ireland - Galway
Galway
United Kingdom3 sites
Saint James's University Hospital Leeds
Leeds, LS9 7TF
University College London Hospitals
London
Sheffield Teaching Hospital
Sheffield, England
About this study
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
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.
- Conditions
- Multiple Myeloma
- Being tested
- GMI-1271
- Keywords
- GMI-1271, bortezomib, carfilzomib, multiple myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GMI-1271Drug
| Study group | Role | What they receive |
|---|---|---|
| Dose 1 | Experimental | Not described Receives: Drug: GMI-1271 |
| Dose 2 | Experimental | Not described Receives: Drug: GMI-1271 |
| Dose 3 | Experimental | Not described Receives: Drug: GMI-1271 |
| Dose 4 | Experimental | Not described Receives: Drug: GMI-1271 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by frequency, severity and relatedness of AEs
Assessed by frequency, severity and relatedness of AEs
Measured: up to 6 months
Overall Response Rate
Overall Response Rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response
Measured: up to 18 months
Secondary outcomes (7)
Clinical benefit rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response + Minimal Response + Stable Disease
Measured: 18 months
Time to response
Measured: 18 months
Time to progression
Measured: 18 months
Duration of response
Measured: 18 months
Progression free survival
Measured: 18 months
Overall survival
Measured: 18 months
Time versus plasma concentration profile of GMI-1271
Measured: up to Day 23 of Cycle 1 (each cycle is 21 or 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionApr 2019
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlycoMimetics Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael O'Dwyer, MD, Principal investigator, National University Ireland - Galway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811822
- Sponsor's protocol ID
- GMI-1271-230
- Status last verified
- Jul 2019
- First submitted
- 20 Jun 2016
- Last updated
- 10 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02811822
- Acronym / sponsor ID
- GMI-1271-230
- Conditions
- Multiple Myeloma
- Keywords
- GMI-1271, bortezomib, carfilzomib, multiple myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- GlycoMimetics IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 23 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose 1 | Experimental | Drug: GMI-1271 |
| Dose 2 | Experimental | Drug: GMI-1271 |
| Dose 3 | Experimental | Drug: GMI-1271 |
| Dose 4 | Experimental | Drug: GMI-1271 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GMI-1271 | Drug | Dose 1, Dose 2, Dose 3, Dose 4 |
Primary outcome
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
7 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2019.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael O'Dwyer, MD principal investigator
National University Ireland - Galway
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GMI-1271 in people with Multiple Myeloma, run by GlycoMimetics Incorporated at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Ireland, United Kingdom, Denmark, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed by frequency, severity and relatedness of AEs (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2019.