75
Participants
Start Date
November 26, 2024
Primary Completion Date
October 1, 2026
Study Completion Date
October 1, 2027
Elranatamab
"Elranatamab: Participants will receive SC administration of elranatamab QW or Q2W. The initial doses of elranatamab will be 12mg (C0D1), 32mg (C0D4), and 76mg (C0D8) and will serve as the 2 step-up priming regimen (Cycle 0). Then, 76mg weekly C1-C6 \> then 76mg bi-weekly from C7 for those achieving PR or better \> then 76mg q4weeks from C12 for those achieving CR or better response. If the participant subsequently begins to have an increase of disease burden not yet qualifying as PD according to IMWG criteria, dose intervals will return to weekly dosing.~premedication for Elranatamab: Acetaminophen 650mg (or paracetamol 500mg), Diphenhydramine 25mg (or equivalent), Dexamethasone 20mg (or equivalent).~In case of mezigdomide discontinuation due to reasons other than disease progression, elranatamab continuation +/- dexamethasone will be allowed until loss of response. The administration of elranatamab +/- dexamethasone will continue per study protocol schedule."
Mezigdomide
"The first day of study treatment dosing with mezigdomide is considered Day 1 of a cycle. (per recommended phase 2 dose, daily \[qd\], D1-21, q 4weeks). Capsules of mezigdomide will be taken by mouth with or without food.~In case of elranatamab discontinuation due to reasons other than disease progression, mezigdomide continuation +/- dexamethasone will be allowed until loss of response. The administration of mezigdomide will continue per study protocol."
Dexamethasone
"Administered at the dose of 20 mg/day from C1-3, then 10mg/day from C4-6 as a premedication for elranatamab.~(for those \>=75 yrs, with uncontrolled diabetes mellitus, history of intolerance: 10mg/day -\> 5mg/day)"
NOT_YET_RECRUITING
Seoul National University Hospital, Seoul
RECRUITING
Seoul National University Hospital, Seoul
YOUNGIL KOH
OTHER