• Active, not recruiting

NCT01668719: Phase 1/2 - S1211 Bort, Dex & Lenalidomide +/- Elotuzumab High Risk NDMM SWOG 1211

Updated: Apr 25

SWOG 1211

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

 

Elotuzumab : National Cancer Institute

Elotuzumab : MedlinePlus Drug Information


Lenalidomide: National Cancer Institute

Lenalidomide: MedlinePlus Drug Information

Dexamethasone : National Cancer Institute

Dexamethasone : MedlinePlus Drug Information


Bortezomib : National Cancer Institute

Bortezomib : MedlinePlus Drug Information

 

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

https://pubmed.ncbi.nlm.nih.gov/26252787/


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

https://ascopubs.org/doi/10.1200/JCO.2020.38.15_suppl.8507


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

https://pubmed.ncbi.nlm.nih.gov/33357482/









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