Participant flow

A Study to Learn About the Study Medicine (Elranatamab) in Participants With Multiple Myeloma That Has Come Back After Responding to Treatment or Has Not Responded to Treatment · Source last updated 2026-02-10

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

groups

1. description

   Participants received elranatamab 4 milligram (mg) on Cycle (C) 1 Day 1 (D) \[C1D1\] and 20 mg on C1D4 and then 76 mg every week (QW) for 6 cycles. Thereafter, participants with partial response (PR) or better response persisting for greater than equal to (\>=) 2 months on QW received 76 mg every 2 weeks (Q2W) and/or 116 mg or 152 mg every 4 weeks (Q4W) from C7 and onwards. One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

   id

   FG000

   title

   Part 1

2. description

   Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

   id

   FG001

   title

   Part 2A: Dose Level 1

3. description

   Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

   id

   FG002

   title

   Part 2A: Dose Level 2

4. description

   Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.

   id

   FG003

   title

   Part 2B

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         4

      4. group Id

         FG003

         num Subjects

         7

      type

      Death

   2. 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

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         6

      4. group Id

         FG003

         num Subjects

         20

      type

      Ongoing

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         33

      2. group Id

         FG001

         num Subjects

         12

      3. group Id

         FG002

         num Subjects

         11

      4. group Id

         FG003

         num Subjects

         29

      type

      STARTED

   2. achievements

      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

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         33

      2. group Id

         FG001

         num Subjects

         12

      3. group Id

         FG002

         num Subjects

         11

      4. group Id

         FG003

         num Subjects

         29

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Results are reported only for primary outcome measure and those secondary outcome measures whose analysis was final at primary completion date (15-June-2023). Remaining secondary outcome measures results would be reported once analysis is final.

recruitment Details

In this study Part 2C was exploratory and there was no participant enrolled in Part 2C as it was not conducted. A total of 86 participants with relapsed/ refractory multiple myeloma were enrolled in this study and 85 participants were treated.

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Preserved source evidence · Not medical advice