Purpose

The purpose of this study is to determine the safety profile and maximum tolerable dose (MTD) of single-agent GBR 1342 in subjects with multiple myeloma who have received prior therapies.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Males or females with multiple myeloma who have exhausted available standard therapies.
  • Measurable disease, defined as any quantifiable monoclonal protein value
  • ECOG performance-status score of 2 or less
  • Life expectancy of at least 3 months
  • Recovered from any previous surgery and no history of major surgery within the last 28 days prior to start of study drug

Exclusion Criteria

  • Any condition that, in the opinion of the Investigator, would interfere with evaluation of the study drug or interpretation of subject safety or study results.
  • Active infectious disease considered by the Investigator to be incompatible with the protocol.
  • Evidence of clinically significant cardiovascular and respiratory conditions
  • Anti-myeloma treatment within 2 weeks
  • Use of any investigational drug within the past 4 weeks

Study Design

Phase
Phase 1
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
GBR 1342
Open-label dose escalation of GBR 1342
  • Biological: GBR 1342
    GBR 1342 will be administered by intravenous (IV) infusion on Day 1 and Day 15 of each 28-day treatment cycle at escalating dose levels

Recruiting Locations

Glenmark Investigational Site 2
Little Rock, Arkansas 72205
Contact:
Faith Davies, MD
FEDavies@uams.edu

Glenmark Investigational Site 3
Baltimore, Maryland 21287
Contact:
Carol Ann Huff, MD
huffca@jhmi.edu

Glenmark Investigational Site 1
Hackensack, New Jersey 07601
Contact:
David Vesole, MD, PhD
david.vesole@hackensackmeridian.org

Glenmark Investigational Site 6
New York, New York 10029
Contact:
Joshua Richter, MD
Joshua.Richter@mssm.edu

Glenmark Investigational Site 4
New York, New York 10065
Contact:
Eric Smith, MD, PhD
smithe3@mskcc.org

Glenmark Investigational Site 8
Nashville, Tennessee 37203
Contact:
Jesus Berdeja, MD
jberdeja@tnonc.com

Glenmark Investigational Site 5
Nashville, Tennessee 37232
Contact:
Robert Cornell, MD
robert.f.cornell@vanderbilt.edu

Glenmark Investigational Site 7
Madison, Wisconsin 53792
Contact:
Aric Hall, MD
achall@medicine.wisc.edu

More Details

NCT ID
NCT03309111
Status
Recruiting
Sponsor
Glenmark Pharmaceuticals S.A.

Study Contact

Vilia Dragovoy
(201) 684-8000
clinicaltrialsdisclosuredesk@glenmarkpharma.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.