Clinical Studies Search

Protocol Summary


Protocol No.
PSCI-21-115
Prinicipal Investigator
Naik, Seema
Phase
Phase III
Age Group
Adult
Scope
National
Secondary Protocol No.
EAA173
Title
EAA173 Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)
Objective
Primary Objective: To compare overall survival in patients with high-risk smoldering multiple myeloma randomized to daratumumab-hyaluronidase subcutaneous (SC)-revlimid-dexamethasone or revlimid-dexamethasone.

Secondary Clinical Objectives:
To compare progression-free survival and response rates between arms. To evaluate safety and compare toxicity rates between arms. To monitor incidence of infusion-related reactions over the first cycle of daratumumab. To evaluate stem cell mobilization failure and early stem cell mobilization feasibility
Applicable Disease Sites
Other Hematopoietic
Status
Open
Participating Institutions
Hershey Medical Center