Overview

GEM-CLARIDEX: Ld vs BiRd

Status:
Active, not recruiting
Trial end date:
2024-10-01
Target enrollment:
Participant gender:
Summary
This phase III study, open-label, randomized study investigating lenalidomide and dexamethasone with and without biaxin in subjects with newly diagnosed, previously untreated MM. Eligible subjects will be randomized in a 1:1 ratio to receive a regimen consisting of either biaxin, lenalidomide, and low-dose dexamethasone (BiRd arm), or lenalidomide and low-dose dexamethasone (Rd arm). 306 patients will be included (50% in Spain (153) and 50% in the USA (153)
Phase:
Phase 3
Details
Lead Sponsor:
PETHEMA Foundation
Collaborator:
Cabyc, S.L.
Treatments:
BB 1101
Clarithromycin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Lenalidomide
Thalidomide