Study Comparing Therapy for Advanced Relapsed/Refractory Multiple Myeloma With and Without Dexamethasone
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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 criteria
Qualifiers
Adult patients (≥18 years old)
Documented MM in relapse according to standard criteria.
All patients must have received between 1 to 3 prior therapies for MM (a prior therapy is defined as 2 or more cycles of therapy given as a MM treatment plan)
ICARIA schema: isatuximab, pomalidomide and dexamethasone.
Disqualifiers
Contraindications to investigational medicinal products or auxiliary medicinal product
Evidence of refractoriness or intolerance to anti-CD38 monoclonal antibodies.
Previous treatment according to the ICARIA schema with pomalidomide or IKEMA schema with carfilzomib
Allogenic hematopoietic cell transplant (HCT, regardless of timing).
Trial design
Treatments tested in this trial
- Dexamethasone
Treatment groups
318 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov