- Active, not recruiting
NCT01668719: Phase 1/2 - S1211 Bort, Dex & Lenalidomide +/- Elotuzumab High Risk NDMM SWOG 1211
Updated: Apr 25, 2022
SWOG 1211
S1211 Bortezomib, Dexamethasone, and Lenalidomide With or Without Elotuzumab in Treating Patients With Newly Diagnosed High-Risk Multiple Myeloma
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.
Sponsors and Collaborators:
Southwest Oncology Group
National Cancer Institute (NCI)
Multiple Locations
ClinicalTrials.gov Identifier: NCT01668719
Official Title: A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide With or Without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM)
Click here for details on Clinicaltrials.gov
Drug: Lenalidomide
Drug: Bortezomib
Drug: Dexamethasone
Biological: Elotuzumab
Other: Laboratory Biomarker Analysis
Phase I safety data of lenalidomide, bortezomib, dexamethasone, and elotuzumab as induction therapy for newly diagnosed symptomatic multiple myeloma: SWOG S1211
Blood Cancer J; 2015
Primary analysis of the randomized phase II trial of bortezomib, lenalidomide, dexamthasone with/without elotuzumab for newly diagnosed, high-risk multiple myeloma (SWOG-1211).
Journal of Clinical Oncology
2020 ASCO Annual Meeting
Bortezomib, lenalidomide, and dexamethasone with or without elotuzumab in patients with untreated, high-risk multiple myeloma (SWOG-1211): primary analysis of a randomised, phase 2 trial
Lancet Haematol; 2021