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Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone
Sponsor: Assistance Publique - Hôpitaux de Paris
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
Conditions
Interventions
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