drugset / Trial / NCT01668719

S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma

NCT01668719

RandomizedParallel-groupOpen-labelTreatment

Summary

This partially randomized phase I/II trial studies the side effects and best dose of elotuzumab and to see how well it works when given together with lenalidomide, bortezomib, and dexamethasone in treating patients with newly diagnosed multiple myeloma that is likely to recur (come back), or spread (high-risk). Lenalidomide and bortezomib may stop the growth of multiple myeloma by blocking blood flow to the tumor. Also, bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as lenalidomide and dexamethasone, also work in different ways to kill cancer cells, by stopping them from dividing, or by stopping them from spreading. Giving elotuzumab together with lenalidomide, bortezomib, and dexamethasone may be a better way to block cancer growth.

Timeline

Start
2012-11
Primary completion
2020-02-05
Completion
2025-09-22

Drugs

EvaluationDrugModalityDoseRoute
Subject Elotuzumab Monoclonal antibody 10 mg/kg
Background Bortezomib Small molecule 1 mg/m2
Background Dexamethasone Small molecule 12 mg
Background Lenalidomide Other / unclassified 15 mg

Indications