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Protocol Summary


Protocol No.
PSCI-23-145
Prinicipal Investigator
Mineishi, Shin

Rovito, Marc

Surapaneni, Rajesh
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
EAA181
Title
Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation
Objective
To determine if bortezomib, daratumumab-hyaluronidase SC, lenalidomide and dexamethasone (Btz-DRd) consolidation followed by daratumumab-hyaluronidase SC and lenalidomide (DR) maintenance after standard induction therapy with daratumumab-hyaluronidase SC, lenalidomide and dexamethasone (DRd) results in superior overall survival compared to DRd consolidation followed by DR maintenance, in MRD positive patients.

To determine if Btz-DRd consolidation followed by DR maintenance after standard induction therapy with DRd results in superior overall survival compared to DRd consolidation followed by DR maintenance in MRD negative patients

To determine if Btz-DRd consolidation followed by DR maintenance after standard induction therapy with DRd results in superior progression-free survival compared to DRd consolidation followed by DR maintenance in both MRD positive and MRD negative patients.

To describe and compare the incidence of toxicities during consolidation between Btz-DRd and DRd arms.
Applicable Disease Sites
Multiple Myeloma
Status
Open
Participating Institutions
Andrews Patel

Hershey Medical Center

St. Joseph Cancer Center