RecruitingPhase 1Phase 2NCT06645678

Mezigdomide and Elranatamab for Relapsed and/or Refractory Multiple Myeloma

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

Sponsor

YOUNGIL KOH

Enrollment

75 participants

Start Date

Nov 26, 2024

Study Type

INTERVENTIONAL

Conditions

Relapsed Refractory Multiple Myeloma (RRMM)

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.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two drugs — mezigdomide (a next-generation immunomodulatory drug) and elranatamab (a targeted bispecific antibody) — for patients with multiple myeloma that has returned or is no longer responding to treatment. **You may be eligible if...** - You are 19 years or older - You have been diagnosed with multiple myeloma with measurable disease - You have received at least 2 prior lines of treatment, including a proteasome inhibitor and lenalidomide - Your disease has progressed on or after your most recent treatment - You are in reasonably good health (ECOG score 0, 1, or 2) **You may NOT be eligible if...** - Your only measurable disease is a plasmacytoma (a single localized tumor) - You have not yet received adequate prior treatment - You have significant organ dysfunction or poor blood counts - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGElranatamab

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.

DRUGMezigdomide

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.

DRUGDexamethasone

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)