Mezigdomide and Elranatamab for Relapsed And/or Refractory Multiple Myeloma

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

November 26, 2024

Primary Completion Date

October 1, 2026

Study Completion Date

October 1, 2027

Conditions
Relapsed Refractory Multiple Myeloma (RRMM)
Interventions
DRUG

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."

DRUG

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."

DRUG

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)"

Trial Locations (2)

Unknown

NOT_YET_RECRUITING

Seoul National University Hospital, Seoul

RECRUITING

Seoul National University Hospital, Seoul

All Listed Sponsors
lead

YOUNGIL KOH

OTHER