Participant flow

A Study of KW-2478 in Combination With Bortezomib in Subjects With Relapsed and/or Refractory Multiple Myeloma · Source last updated 2024-04-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   The target population in Phase 1 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine. For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m\^2) and bortezomib(1.0 or 1.3 mg/m\^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.

   id

   FG000

   title

   Phase 1: KW-2478 and Bortezomib

2. description

   The target population in Phase 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1-3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine. For the Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and bortezomib at the RP2D (KW-2478 175 mg/m\^2/bortezomib1.3 mg/m\^2).

   id

   FG001

   title

   Phase II: KW-2478 130mg/m^2 and Bortezomib 1.3mg/m^2

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         80

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         15

      2. group Id

         FG001

         num Subjects

         80

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

Study centers in the USA and the UK participated in the Phase 1 portion, and study centers in the USA, UK, and Philippines participated in the Phase 2 portion.

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Preserved source evidence · Not medical advice