Participant flow

Safety/Efficacy Study of LDE225 (Sonidegib) Plus Bortezomib in Patients With Relapsed or Relapsed/Refractory Multiple Myeloma · Source last updated 2017-02-16

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

groups

1. description

   Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle. Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle. Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity.

   id

   FG000

   title

   LDE225 Plus Bortezomib

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Physician Decision

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Dose-limiting toxicity

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         7

      type

      STARTED

   2. achievements

      1. comment

         1 patient was found to be refractory to bortezomib and deemed ineligible.

         group Id

         FG000

         num Subjects

         7

      type

      Cohort 1: LDE225 400mg

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      Cohort 2: LDE225 600mg

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      Cohort 3: LDE225 800mg

   5. achievements

      1. comment

         Due to toxicity and lack of efficacy, no other dose levels were examined.

         group Id

         FG000

         num Subjects

         4

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         3

      type

      NOT COMPLETED

   title

   Dose Escalation

2. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Expansion

3. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Maintenance

pre Assignment Details

7 patients received at least 1 cycle (21 days) of treatment on dose level 1.

recruitment Details

The primary objective of this study was to investigate safety, tolerability and determine the maximum tolerated dose (MTD) of LDE225 to administer along with a fixed dose of bortezomib. Between March 2015 and September 2015, 7 patients were enrolled in the safety lead-in part of the study at 4 investigational sites in the U.S.

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice