Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: GMI-1271
bortezomib
carfilzomib
multiple myeloma
Lead sponsor: GlycoMimetics Incorporated
Sponsor class: INDUSTRY
First posted: 2016-06-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety assessed by frequency, severity and relatedness of AEs
timeFrame: up to 6 months
measure: Overall Response Rate
timeFrame: up to 18 months
Secondary outcomes:
measure: Clinical benefit rate = Stringent Complete Response + Complete Response + Very Good Partial Response + Partial Response + Minimal Response + Stable Disease
timeFrame: 18 months
measure: Time to response
timeFrame: 18 months
measure: Time to progression
timeFrame: 18 months
measure: Duration of response
timeFrame: 18 months
measure: Progression free survival
timeFrame: 18 months
measure: Overall survival
timeFrame: 18 months
measure: Time versus plasma concentration profile of GMI-1271
timeFrame: up to Day 23 of Cycle 1 (each cycle is 21 or 28 days)
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital
city: Heidelberg
country: Germany
facility: Medizinische Klinik/Abt. Innere Medizin V
city: Cork
country: Ireland
facility: Cork University Hospital, Wilton
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Galway
country: Ireland
facility: National University Ireland - Galway
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospital
state: England
city: Leeds
country: United Kingdom
facility: Saint James's University Hospital Leeds
city: London
country: United Kingdom
facility: University College London Hospitals
Study officials:
affiliation: National University Ireland - Galway
name: Michael O'Dwyer, MD
role: PRINCIPAL_INVESTIGATOR
References: