Participant flow

A Study of JNJ-68284528 Out-of-Specification (OOS) for Commercial Release in Participants With Multiple Myeloma · Source last updated 2025-04-25

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

groups

1. description

   Adult participants aged 18 years or older, with multiple myeloma received the lymphodepleting chemotherapy (cyclophosphamide 300 milligrams per meter square \[mg/m\^2\] intravenous \[IV\] infusion and fludarabine 30 mg/m\^2 IV infusion daily, for 3 days \[Day -7 to Day -5\]). After 5 to 7 days of initiating lymphodepleting chemotherapy, participants received IV infusion of cilta-cel OOS at a total targeted dose of 0.75\*10\^6 chimeric antigen receptor (CAR)-positive viable T-cells/kg (dose range 0.5\*10\^6 CAR-positive viable T cells/kg to 1.0\*10\^6 CAR-positive viable T cells/kg) based on participant's body weight at apheresis or per exceptional release criteria determined alternative dose.

   id

   FG000

   title

   Ciltacabtagene Autoleucel (Cilta-cel) Out-of-Specification (OOS)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         14

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         13

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Progressive Disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         49

      type

      Study Terminated by Sponsor

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Other

   7. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Enrolled (consented) but not treated

   8. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Disease Relapse

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         86

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         82

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         86

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice