A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
The purpose of this study is to assess the safety and benefits of the investigational study drug, KW-2478, when given with bortezomib (Velcade®), a drug approved for the treatment of Multiple Myeloma (MM). The primary objectives: * To establish the safety, tolerability, and recommended Phase II dose (RP2D) of KW-2478 in combination with bortezomib (Phase I); * To assess the overall response rate (ORR) when subjects with advanced MM are treated (Phase II). The secondary objectives: * To characterize the Pharmacokinetic (PK) and Pharmacodynamic (PD) of KW-2478 with bortezomib (Phase I only); * To evaluate for preliminary evidence of efficacy (Phase I); * To determine progression free survival (PFS) and duration of response of KW-2478 with bortezomib (Phase II).
Checked against the public recordLast updated Apr 25, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Kyowa Kirin Co., Ltd.
- Interventions being studied
- Drug: KW-2478; Drug: Bortezomib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Accepts Healthy Volunteers: No Inclusion Criteria: 1. Subjects with a confirmed diagnosis of Multiple Myeloma who have had one and no more than three prior regimens for MM to which they did not respond (failed) or from which they have relapsed. 2. Signed either an IRB or IEC approved informed consent 3. ECOG performance status of ≤ 2 4. Life expectancy of at least 3 months 5. M protein in either serum or urine, or free light chains if not measurable M protein in serum or urine, and clonal bone marrow plasma cells \> 10%, and evidence of end organ damage 6. Adequate hematologic status, liver and renal function 7. Subjects of reproductive potential must agree to follow accepted pregnancy prevention methods during the study. Exclusion Criteria: 1. No anti-cancer treatment for ≥ 4 weeks and no bortezomib treatment ≥ 60 days prior to receiving study drug 2. Any other severe, acute or chronic illness 3. No other prior or concurrent malignancy 4. No immunosuppressant therapy
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Arizona Clinical Research Center, Inc. / Arizona Oncology Associates, 1825 N Kolb,Tucson, Arizona
- Pacific Shores Medical Group 1043 Elm Ave, Suite 104Long Beach, California
- UCLA Medical Center Hematology / Oncology Division, 10945 Le Conte Ave #2333,Los Angeles, California
- Collaborative Research Group 2320 S Seacrest Blvd, Suite 202Boynton Beach, Florida
- Rush University Medical Center / Division of Hematology/Oncology Research 1725 W Harrison Street, Suite 834Chicago, Illinois
- Cancer Institute of New Jersey 195 Little Albany StreetNew Brunswick, New Jersey
- The Jones Clinic 7710 Wolf River CircleGermantown, Tennessee
- UT MD Anderson Cancer Center, 1515 Holcombe Boulevard,Houston, Texas
- Gundersen Clinic Center for Cancer and Blood Disorders, 1900 South Ave, EB2-001,La Crosse, Wisconsin
- The Medical City, 1609 MATI Building, The Medical City, Ortigas Avenue,Pasig, Manila
- National Kidney and Transplant Institute, Rm 3215 Doctors Clinic, East AvenueDiliman, Quezon City
- Makati Medical Center, New Wing Hall C372, #2 Amorsolo Street, Legaspi Village,Makati City
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 25, 2024. Always confirm current availability with the study team.