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RECRUITING
NCT06561854
PHASE3

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

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

318

Start Date

2024-12-12

Completion Date

2028-12

Last Updated

2024-12-18

Healthy Volunteers

No

Interventions

DRUG

Dexamethasone

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)

Locations (1)

Service d'hématologie clinique et thérapie cellulaire, Saint-Antoine Hospital

Paris, France