Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma

Sponsor
YOUNGIL KOH
Study ID
NCT06645678
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Relapsed Refractory Multiple Myeloma (RRMM)

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Elranatamab — DRUG
    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 — DRUG
    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 — DRUG
    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)

Study Details

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.

Key Dates

Start date
Nov 26, 2024
Status verified
Nov 2025
Primary completion
Oct 1, 2026
Completion
Oct 1, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment arm
    Participants will receive elranatamab, mezigdomide and dexamethasone. Part 1 (safety cohort): approximately 12 participants to select the optimal RP2D and to assess the safety, tolerability, and preliminary efficacy. Every cycle consists of 28 days. 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.

Primary Outcome Measure

Overall response rate (ORR) [ Time Frame: From C1D1 to confirmed PD, lost to follow-up, or death (whichever occurs first), assessed up to 24 months ]

Central Contacts

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