OncoMatch/Clinical Trials/NCT06561854
Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone
Is NCT06561854 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies Dexamethasone for multiple myeloma.
Treatment: Dexamethasone — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: antibody-based approved combination (isatuximab, pomalidomide, dexamethasone) — ICARIA schema
ICARIA schema: isatuximab, pomalidomide and dexamethasone
Must have received: antibody-based approved combination (isatuximab, carfilzomib, dexamethasone) — IKEMA schema
IKEMA schema: isatuximab, carfilzomib and dexamethasone
Cannot have received: anti-CD38 monoclonal antibody
Evidence of refractoriness or intolerance to anti-CD38 monoclonal antibodies.
Cannot have received: ICARIA schema with pomalidomide (pomalidomide)
Previous treatment according to the ICARIA schema with pomalidomide
Cannot have received: IKEMA schema with carfilzomib (carfilzomib)
Previous treatment according to the IKEMA schema with carfilzomib
Cannot have received: allogenic hematopoietic cell transplant
Allogenic hematopoietic cell transplant (HCT, regardless of timing).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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