Participant flow

Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 397 in Subjects With Selected Relapsed or Refractory Hematological Malignancies · Source last updated 2023-04-12

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

groups

1. description

   Participants with relapsed/refractory (RR) multiple myeloma (MM) and/or non-Hodgkin's lymphoma (NHL) received 80 mg AMG 397 once a day for 2 consecutive days followed by a 5 day break at a weekly interval (QD2), as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.

   id

   FG000

   title

   Part 1a: 80 mg AMG 397

2. description

   Participants with RR MM and/or NHL received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.

   id

   FG001

   title

   Part 1a: 160 mg AMG 397

3. description

   Participants with RR MM received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.

   id

   FG002

   title

   Part 1a: 320 mg AMG 397

4. description

   Participants with RR acute myeloid leukemia (AML) received 80 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.

   id

   FG003

   title

   Part 1b: 80 mg AMG 397

5. description

   Participants with RR AML received 160 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.

   id

   FG004

   title

   Part 1b: 160 mg AMG 397

6. description

   Participants with RR AML received 320 mg AMG 397 QD2, as part of a 28-day treatment cycle. Participants could receive AMG 397 until the participant became intolerant to the investigational product, signs and symptoms of clinical progression were evident as determined by the investigator, or the participant withdrew consent.

   id

   FG005

   title

   Part 1b: 320 mg AMG 397

periods

1. drop Withdraws

   1. 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

         1

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         0

      type

      Withdrawal by Subject

   2. reasons

      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

         0

      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

         0

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         0

      6. group Id

         FG005

         num Subjects

         2

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         2

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         2

      6. group Id

         FG005

         num Subjects

         0

      type

      Protocol specified criteria

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         5

      6. group Id

         FG005

         num Subjects

         3

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         4

      5. group Id

         FG004

         num Subjects

         5

      6. group Id

         FG005

         num Subjects

         3

      type

      Received AMG 397

   3. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         1

      6. group Id

         FG005

         num Subjects

         1

      comment

      Completed Study

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         3

      5. group Id

         FG004

         num Subjects

         4

      6. group Id

         FG005

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Parts 2 and 3 of the trial were not initiated after part 1 data was reviewed. No participants were screened or enrolled for parts 2 or 3.

recruitment Details

Participants were enrolled at 11 research centers in Australia, France, Greece and the United States from 17 August 2018 to 25 July 2019.

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

Preserved source evidence · Not medical advice