Condition: Multiple Myeloma · Relapse Multiple Myeloma · Sponsor: Assistance Publique - Hôpitaux de Paris
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.
This description comes directly from the study's public registry record.
Mohamad MOHTY, PU-PH · + 33 1 49 28 26 20 · mohamad.mohty@inserm.fr
Florent MALARD, PU-PH · 01 49 28 34 39 · malardf@yahoo.fr
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| Service d'hématologie clinique et thérapie cellulaire, Saint-Antoine Hospital | Paris, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06561854