NCT05228470 · FLOW
Participant flow
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- groups
- description
- Participants received subcutaneous (SC) elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 (C1D1) and 32 mg on Cycle 1 Day 4 (C1D4) followed by 76 mg weekly (QW) thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. If a participant had received QW dosing for at least 6 cycles and had achieved a partial response (PR) or better persisting for at least 2 months, the dose interval was changed to once every 2 weeks (Q2W).
- id
- FG000
- title
- Phase 1b
- description
- Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. If a participant had received QW dosing for at least 6 cycles and had achieved a PR or better persisting for at least 2 months, the dose interval was changed to Q2W.
- id
- FG001
- title
- Phase 2
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 11
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 8
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 11
- type
- Ongoing
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 30
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 30
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- A total of 38 participants were enrolled and assigned to study treatment. Data for only those primary and secondary outcome measures whose analysis is complete and final have been reported. Data for remaining secondary outcome measures will be posted upon completion of analysis at study completion date.
- recruitment Details
- Chinese participants with relapsed/refractory multiple myeloma (RRMM), who were refractory to at least 1 proteasome inhibitor (PI), 1 immunomodulatory drug (IMiD), and 1 anti-cluster of differentiation38 monoclonal antibody (anti-CD38 mAB) were included.
Complete source fields
- groups
- description
- Participants received subcutaneous (SC) elranatamab with a priming regimen of 12 milligrams (mg) on Cycle 1 Day 1 (C1D1) and 32 mg on Cycle 1 Day 4 (C1D4) followed by 76 mg weekly (QW) thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. If a participant had received QW dosing for at least 6 cycles and had achieved a partial response (PR) or better persisting for at least 2 months, the dose interval was changed to once every 2 weeks (Q2W).
- id
- FG000
- title
- Phase 1b
- description
- Participants received SC elranatamab with a priming regimen of 12 mg on C1D1 and 32 mg on C1D4 followed by 76 mg QW thereafter starting from Cycle 1 Day 8. Each cycle was 28 days. If a participant had received QW dosing for at least 6 cycles and had achieved a PR or better persisting for at least 2 months, the dose interval was changed to Q2W.
- id
- FG001
- title
- Phase 2
- periods
- drop Withdraws
- reasons
- group Id
- FG000
- num Subjects
- 6
- group Id
- FG001
- num Subjects
- 11
- type
- Death
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 8
- type
- Withdrawal by Subject
- reasons
- group Id
- FG000
- num Subjects
- 1
- group Id
- FG001
- num Subjects
- 11
- type
- Ongoing
- milestones
- achievements
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 30
- type
- STARTED
- achievements
- group Id
- FG000
- num Subjects
- 0
- group Id
- FG001
- num Subjects
- 0
- type
- COMPLETED
- achievements
- group Id
- FG000
- num Subjects
- 8
- group Id
- FG001
- num Subjects
- 30
- type
- NOT COMPLETED
- title
- Overall Study
- pre Assignment Details
- A total of 38 participants were enrolled and assigned to study treatment. Data for only those primary and secondary outcome measures whose analysis is complete and final have been reported. Data for remaining secondary outcome measures will be posted upon completion of analysis at study completion date.
- recruitment Details
- Chinese participants with relapsed/refractory multiple myeloma (RRMM), who were refractory to at least 1 proteasome inhibitor (PI), 1 immunomodulatory drug (IMiD), and 1 anti-cluster of differentiation38 monoclonal antibody (anti-CD38 mAB) were included.
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