Clinical trial · Interventional
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
NCT02811822CI-TRIAL-00039422completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GMI-1271 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose 1
- interventionNames
- Drug: GMI-1271
- type
- EXPERIMENTAL
- label
- Dose 2
- interventionNames
- Drug: GMI-1271
- type
- EXPERIMENTAL
- label
- Dose 3
- interventionNames
- Drug: GMI-1271
- type
- EXPERIMENTAL
- label
- Dose 4
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.