Multiple Myeloma Clinical Trial
Official title:
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
Verified date | April 2024 |
Source | Kyowa Kirin Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 95 |
Est. completion date | November 2013 |
Est. primary completion date | November 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
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 | The Medical City, 1609 MATI Building, The Medical City, Ortigas Avenue, | Pasig City | Manila |
Philippines | Saint Lukes Medical Center, Rm 222 MAB Saint Lukes Medical Center, E. Rodriguez | Quezon City | |
United Kingdom | St Bartholomew's Hospital Haematology Department, 1st Floor, Pathology | Barbican | London |
United Kingdom | Royal Bournemouth Hospital, Dept. of Haematolgy, Castle Lane East, | Bournemouth | |
United Kingdom | Darent Valley Hospital Dept of Haematology, Acorn House, Darenth Wood Road | Dartford | Kent |
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 | Royal Marsden Hospital, Orchard House | Sutton | Surrey |
United Kingdom | Royal Cornwall Hospital Haematology Clinic | Truro | |
United Kingdom | Hillingdon Hospital Dept of Haematology, Pield Health Road | Uxbridge | Middlesex |
United Kingdom | Christie Hospital - Department Haematology, 550 Wilmslow Road | Withington | Manchester, Greater Manchester |
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 | 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 | 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 | Cancer Institute of New Jersey 195 Little Albany Street | New Brunswick | New Jersey |
United States | Arizona Clinical Research Center, Inc. / Arizona Oncology Associates, 1825 N Kolb, | Tucson | Arizona |
Lead Sponsor | Collaborator |
---|---|
Kyowa Kirin Co., Ltd. | Kyowa Hakko Kirin Pharma, Inc. |
United States, Philippines, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To Establish the Safety, Tolerability, and RP2D (Phase 1); To Assess the Overall Response Rate in Subjects With Advanced Multiple Myeloma (Phase 2). | The safety of KW-2478 was determined by reported TEAEs, observed DLTs, changes in PEs, vital sign measurements, ECGs, and laboratory analyses. The ORR, was defined as the best response over a specified number of cycles (calculated and summarized). Disease control rate (DCR) was defined as the best response over a specified number of cycles (calculated and summarized). Progression-free survival was defined as the time from the first day of treatment until the date of disease progression or death is first reported (calculated and summarized). |
21 day cycle, up to 52 weeks | |
Secondary | Phase 1: PK Absorption Tmax hr Day 11 | Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day. | PK collected Day 11 of 21-day cycle | |
Secondary | Phase 1: PK Exposure Cmax ng/mL Day 11 | Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day. | PK collected Day 11 of 21-day cycle | |
Secondary | Phase 1: PK Exposure AUC0-t hr*ng/mL Day 11 | Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day. | PK collected Day 11 of 21-day cycle | |
Secondary | Phase 1: PK Elimination t½ hr Day 11 | Descriptive summary statistics (number, arithmetic mean, standard deviation [SDev], coefficient of variation [CV%]) for concentration and PK data for KW-2478 and Bortezomib in Phase 1 were presented by cohort, dose level and day. | PK collected Day 11 of 21-day cycle |
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