Participant flow

A Study Evaluating The Safety And Pharmacokinetics Of Escalating Doses Of RO7297089 In Patients With Relapsed Or Refractory Multiple Myeloma · Source last updated 2024-07-03

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

groups

1. description

   Participants in Arm A received 60 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit

   id

   FG000

   title

   Dose Escalation Cohort 1: RO7297089

2. description

   Participants in Arm A received 180 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit

   id

   FG001

   title

   Dose Escalation Cohort 2: RO7297089

3. description

   Participants in Arm A received 360 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit

   id

   FG002

   title

   Dose Escalation Cohort 3: RO7297089

4. description

   Participants in Arm A received 1080 mg dose of RO7297089 as a flat dose at each scheduled study drug administration visit

   id

   FG003

   title

   Dose Escalation Cohort 4: RO7297089

5. description

   Participants in Arm B received the 1080 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose wasadministered at subsequent study drug administration visits.

   id

   FG004

   title

   Dose Escalation Backfill Cohort 4: RO7297089

6. description

   Participants in Arm B received the 1850 mg dose of RO7297089 as a split dose divided over two days (Days 1 and 2). The full target dose was administered at subsequent study drug administration visits.

   id

   FG005

   title

   Dose Escalation Cohort 5: RO7297089

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         3

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         0

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         3

      6. group Id

         FG005

         num Subjects

         3

      type

      Study terminated by sponsor

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         3

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         0

      comment

      Alive: In Follow-up

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         6

      6. group Id

         FG005

         num Subjects

         3

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

The study consisted of a screening period of up to 28 days and a minimum follow-up period of 90 days after treatment. Following confirmation of eligibility, patients received RO7297089 by intravenous (IV) infusion. Patients were enrolled in two stages: a dose escalation stage and an expansion stage.

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Preserved source evidence · Not medical advice