RecruitingPhase 3NCT06561854

Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone

Free Regimen of Dexamethasone as Initial Therapy for Advanced Relapsed/Refractory Multiple Myeloma: an Open-label Randomized, Non-inferiority, Controlled Trial

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

318 participants

Start Date

Dec 12, 2024

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma Relapse Multiple Myeloma

Summary

Patients with relapsed/refractory symptomatic multiple myeloma who meet all inclusion criteria, will be randomized 1:1 to receive either standard of care chemotherapy (IKEMA or ICARIA) and dexamethasone until disease progression ("dexamethasone arm", arm A) or standard of care chemotherapy (IKEMA or ICARIA) and dexamethasone with dexamethasone discontinuation from the 3rd cycle of treatment (after 8 weeks) ("dexamethasone-free arm", arm B). In most centers, IKEMA and ICARIA schema can be adapted according to the standard of care in each center Choice between the ICARIA and IKEMA schema is at the discretion of the investigator, in compliance with each drug's SmPC, but must be performed before randomisation for the purpose of stratification.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether the drug dexamethasone (a steroid) can be safely removed from standard combination treatment for people with relapsed multiple myeloma (a blood cancer) who are receiving isatuximab-based therapy, to reduce steroid-related side effects. **You may be eligible if...** - You are 18 or older with multiple myeloma that has relapsed after 1–3 prior treatment lines - You responded to your prior treatment (at least a partial response) - You are eligible for either the isatuximab + pomalidomide + dexamethasone or the isatuximab + carfilzomib + dexamethasone combination **You may NOT be eligible if...** - You have already been treated with pomalidomide or carfilzomib in the relevant combination - You are known to be resistant to anti-CD38 antibody therapy - You have had an allogeneic (donor) stem cell transplant - You have active hepatitis B with detectable virus, HIV, or hepatitis C - You are breastfeeding or participating in another interventional clinical trial 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.

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Interventions

DRUGDexamethasone

ICARIA schema : 40mg (20mg for ≥75yr) on day 1, 8, 15, 22 of each cycle plus IKEMA schema : 20 mg on day 1-2, day 8-9, day 15-16 and day 22-23 of each cycle For subjects older than 75 years or underweight (BMI \<18.5), the dexamethasone dose may be administered at a total dose of 20 mg weekly. In both schema (ICARIA or IKEMA), dexamethasone will be administrated up to 2 cycle (Arm 1) or until disease progression (Arm2)