Participant flow

LBH589 in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia · Source last updated 2021-01-28

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

groups

1. description

   30 mg three days a week (Mondays, Wednesdays and Fridays). 1 cycle was 28 days Dose modifications for attributable toxicities allowed for reduction to: * 25 mg, 20 mg three times a week every week * Or 20 mg three times a week every other week. No dose re-escalation was allowed. * The protocol was amended on 6/15/2010 because of concerns of toxicity to allow a starting dose of 25 mg; 12/36 (33%) patients were enrolled on the 25 mg dose. LBH589

   id

   FG000

   title

   LBH589

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Progressive Disease

   2. reasons

      1. group Id

         FG000

         num Subjects

         22

      type

      New Systemic Therapy

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Still on Follow-up

   6. reasons

      1. group Id

         FG000

         num Subjects

         7

      type

      Still on Active Therapy

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Ineligible for Study Drug

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         39

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         36

      comment

      3 patients deemed ineligible

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         12

      comment

      Protocol Amendment 6/15/2010. Study drug starting dose reduced.

      type

      Starting Dose Reduction: 30 mg to 25 mg

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      comment

      Since treatment was not of fixed duration, all participants were considered as 'Not Completed' and reason off-treatment is provided.

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         39

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

From July 2009 to March 2011

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Preserved source evidence · Not medical advice