A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma
Completed · Phase 1/Phase 2
Conditions studied: Multiple Myeloma
In brief
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).
Key facts
- Study ID
- NCT01063907
- Run by
- Kyowa Kirin Co., Ltd.
- People needed
- 95
- Starts
- 2010-03-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2024-04-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Signed either an IRB or IEC approved informed consent
- ECOG performance status of ≤ 2
- Life expectancy of at least 3 months
- 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
- Adequate hematologic status, liver and renal function
- Subjects of reproductive potential must agree to follow accepted pregnancy prevention methods during the study.
You may not qualify if…
- No anti-cancer treatment for ≥ 4 weeks and no bortezomib treatment ≥ 60 days prior to receiving study drug
- Any other severe, acute or chronic illness
- No other prior or concurrent malignancy
- No immunosuppressant therapy
Where it is running
- Arizona Clinical Research Center, Inc. / Arizona Oncology Associates, 1825 N Kolb, — Tucson, Arizona, United States
- Pacific Shores Medical Group 1043 Elm Ave, Suite 104 — Long Beach, California, United States
- UCLA Medical Center Hematology / Oncology Division, 10945 Le Conte Ave #2333, — Los Angeles, California, United States
- Collaborative Research Group 2320 S Seacrest Blvd, Suite 202 — Boynton Beach, Florida, United States
- Rush University Medical Center / Division of Hematology/Oncology Research 1725 W Harrison Street, Suite 834 — Chicago, Illinois, United States
- Cancer Institute of New Jersey 195 Little Albany Street — New Brunswick, New Jersey, United States
- The Jones Clinic 7710 Wolf River Circle — Germantown, Tennessee, United States
- UT MD Anderson Cancer Center, 1515 Holcombe Boulevard, — Houston, Texas, United States
- Gundersen Clinic Center for Cancer and Blood Disorders, 1900 South Ave, EB2-001, — La Crosse, Wisconsin, United States
- The Medical City, 1609 MATI Building, The Medical City, Ortigas Avenue, — Pasig, Manila, Philippines
- National Kidney and Transplant Institute, Rm 3215 Doctors Clinic, East Avenue — Diliman, Quezon City, Philippines
- Makati Medical Center, New Wing Hall C372, #2 Amorsolo Street, Legaspi Village, — Makati City, Philippines
- Saint Lukes Medical Center, Rm 222 MAB Saint Lukes Medical Center, E. Rodriguez — Quezon City, Philippines
- Darent Valley Hospital Dept of Haematology, Acorn House, Darenth Wood Road — Dartford, Kent, United Kingdom
- St Bartholomew's Hospital Haematology Department, 1st Floor, Pathology — Barbican, London, United Kingdom
- Christie Hospital - Department Haematology, 550 Wilmslow Road — Withington, Manchester, Greater Manchester, United Kingdom
- Hillingdon Hospital Dept of Haematology, Pield Health Road — Uxbridge, Middlesex, United Kingdom
- Royal Marsden Hospital, Orchard House — Sutton, Surrey, United Kingdom
- Royal Bournemouth Hospital, Dept. of Haematolgy, Castle Lane East, — Bournemouth, United Kingdom
- Royal Devon & Exeter Hospital Haematology Centre, Barrack Road — Exeter, United Kingdom
- Northwick Park Hospital Dept of Haematology, Watford Road — Harrow, United Kingdom
- St James Hospital, St James' Institute of Oncology, Department of Haematology, Level 03, Bexley Wing, — Leeds, United Kingdom
- UCL Cancer Institute, Paul O'Gorman Building, University College London,72 Huntley Street — London, United Kingdom
- Manchester Royal Infirmary Dept of Haematology, Oxford Road — Manchester, United Kingdom
- Nottingham University Hospitals NHS Trust, Centre for Clinical Haemotology — Nottingham, United Kingdom
Full record on ClinicalTrials.gov
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