Conditions: Multiple Myeloma
Keywords: Leukemia Immunoproliferative Disorder Neoplasma by Histologic Type Immune System Diseases Hematologic Diseases Blood Protein Disorders Paraproteinemias Multiple Myeloma Hematologic Disorders Leukemia, Chronic, B-cell Leukemia, B-cell Leukemia, Chronic Neoplasms, Plasma Cell Monoclonal Gammopathy of unknown significance (MGUS)
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 95
Healthy volunteers: no

Brief 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).

Detailed 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.

Arms:
arm 1: Cohort 1: KW 2478 130 mg/m\^2 and Bortezomib 1.0 mg/m\^2 arm 2: Cohort 2: KW 2478 130 mg/m\^2 and Bortezomib 1.3 mg/m\^2 arm 3: Cohort 3: KW 2478 175 mg/m\^2 and Bortezomib 1.0 mg/m\^2 arm 4: Cohort 4: KW 2478 175 mg/m\^2 and Bortezomib 1.3 mg/m\^2 arm 5: KW 2478 175 mg/m\^2 and Bortezomib 1.0 mg/m\^2

Interventions: intervention 1: KW-2478 intervention 2: Bortezomib
Intervention descriptions: intervention 1: Administered Days 1, 4, 8 and 11 of a 21 day cycle intervention 2: Administered on Days 1, 4, 8 and 11 of a 21 day cycle

Protocol document: