NCT06645678

Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma

Phase I/II Study of Mezigdomide and Elranatamab for Relapsed/Refractory Multiple Myeloma Patients

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: YOUNGIL KOH · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to find out how well a combination of two medicines (mezigdomide and elranatamab) works in treating patients with refractory/relapsed multiple myeloma.

Detailed description

This is a phase I/II (2 parts), open-label, single arm, multicenter study to evaluate the efficacy and safety of elranatamab in combination with mezigdomide. Part 1 (safety cohort): Since the combination of elranatamab with mezigdomide has not previously been evaluated, Part 1 (safety cohort) of the study will be conducted in up to approximately 12 participants to select the optimal RP2D and to assess the safety, tolerability, and preliminary efficacy. Part 2 (expansion cohort): In Part 2 (expansion cohort), approximately 63 participants will be enrolled. The primary objective of Part 2 is to determine the overall response rate per IMWG criteria at 24 months after enrollment. Participants will receive elranatamab, mezigdomide and dexamethasone.

Conditions

• Relapsed Refractory Multiple Myeloma (RRMM)

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2024-11-26
• Primary completion: 2026-10-01
• Completion: 2027-10-01
• First posted: 2024-10-17
• Last updated: 2025-12-03

Locations

7 sites across 2 countries: Singapore, South Korea