Multiple Myeloma Clinical Trial

A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma

Summary

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).

View Full Description

Full Description

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.

View Eligibility Criteria

Eligibility Criteria

Accepts Healthy Volunteers: No

Inclusion Criteria:

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.

Exclusion Criteria:

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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

95

Study ID:

NCT01063907

Recruitment Status:

Completed

Sponsor:

Kyowa Kirin Co., Ltd.

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There are 22 Locations for this study

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Arizona Clinical Research Center, Inc. / Arizona Oncology Associates, 1825 N Kolb,
Tucson Arizona, 85715, United States
Pacific Shores Medical Group 1043 Elm Ave, Suite 104
Long Beach California, 90813, United States
UCLA Medical Center Hematology / Oncology Division, 10945 Le Conte Ave #2333,
Los Angeles California, 90095, United States
Collaborative Research Group 2320 S Seacrest Blvd, Suite 202
Boynton Beach Florida, 33435, United States
Rush University Medical Center / Division of Hematology/Oncology Research 1725 W Harrison Street, Suite 834
Chicago Illinois, 60612, United States
Cancer Institute of New Jersey 195 Little Albany Street
New Brunswick New Jersey, 08903, United States
The Jones Clinic 7710 Wolf River Circle
Germantown Tennessee, 38138, United States
UT MD Anderson Cancer Center, 1515 Holcombe Boulevard,
Houston Texas, 77030, United States
Gundersen Clinic Center for Cancer and Blood Disorders, 1900 South Ave, EB2-001,
La Crosse Wisconsin, 54601, United States
The Medical City, 1609 MATI Building, The Medical City, Ortigas Avenue,
Pasig City 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, DA2 8, United Kingdom
St Bartholomew's Hospital Haematology Department, 1st Floor, Pathology
Barbican London, EC1 7, United Kingdom
Christie Hospital - Department Haematology, 550 Wilmslow Road
Withington Manchester, Greater Manchester, M20 4, United Kingdom
Hillingdon Hospital Dept of Haematology, Pield Health Road
Uxbridge Middlesex, UB8 3, United Kingdom
Royal Marsden Hospital, Orchard House
Sutton Surrey, SM2 5, United Kingdom
Royal Bournemouth Hospital, Dept. of Haematolgy, Castle Lane East,
Bournemouth , BH7 7, United Kingdom
Royal Devon & Exeter Hospital Haematology Centre, Barrack Road
Exeter , EX2 5, United Kingdom
Northwick Park Hospital Dept of Haematology, Watford Road
Harrow , HA1 3, United Kingdom
St James Hospital, St James' Institute of Oncology, Department of Haematology, Level 03, Bexley Wing,
Leeds , LS9 7, United Kingdom
UCL Cancer Institute, Paul O'Gorman Building, University College London,72 Huntley Street
London , WC1E , United Kingdom
Manchester Royal Infirmary Dept of Haematology, Oxford Road
Manchester , M13 9, United Kingdom
Nottingham University Hospitals NHS Trust, Centre for Clinical Haemotology
Nottingham , NG5 1, United Kingdom
Royal Cornwall Hospital Haematology Clinic
Truro , TR1 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

95

Study ID:

NCT01063907

Recruitment Status:

Completed

Sponsor:


Kyowa Kirin Co., Ltd.

How clear is this clinincal trial information?

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