An Open Label, Dose Escalation, Multicenter Phase 1/2 Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
This is a multicenter, open label, dose escalation, Phase I / II study in subjects with
relapsed and/or refractory MM. Up to 24 subjects to be enrolled in the Phase I to determine
the RP2D. Up to 77 additional evaluable subjects to be enrolled in Phase II for a maximum up
to 101 subjects treated in the study. Study centers in the USA and the UK will participate
in Phase I and II. Centers in the Philippines will be participating in Phase II only. The
planned enrollment period is 22 months and the planned study duration is 28 months.
Accepts Healthy Volunteers: No
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objectives: To establish the safety, tolerability, and RP2D (Phase I); To assess the overall response rate in subjects with advanced Multiple Myeloma (Phase II).
21 day cycle
Michael Kurman, MD
Kyowa Hakko Kirin Pharma, Inc.
United States: Food and Drug Administration
|Arizona Clinical Research Center, Inc. / Arizona Oncology Associates, 1825 N Kolb,||Tucson, Arizona 85715|
|Pacific Shores Medical Group 1043 Elm Ave, Suite 104||Long Beach, California 90813|
|UCLA Medical Center Hematology / Oncology Division, 10945 Le Conte Ave #2333,||Los Angeles, California 90095-7059|
|Collaborative Research Group 2320 S Seacrest Blvd, Suite 202||Boynton Beach, Florida 33435|
|Rush University Medical Center / Division of Hematology/Oncology Research 1725 W Harrison Street, Suite 834||Chicago, Illinois 60612|
|Cancer Institute of New Jersey 195 Little Albany Street||New Brunswick, New Jersey 08903-2681|
|The Jones Clinic 7710 Wolf River Circle||Germantown, Tennessee 38138|
|UT MD Anderson Cancer Center, 1515 Holcombe Boulevard,||Houston, Texas 77030|
|Gundersen Clinic Center for Cancer and Blood Disorders, 1900 South Ave, EB2-001,||La Crosse, Wisconsin 54601|