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

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

Outcome

Missed primary endpoint

paper no difference in median progression-free survival was observed (RVd 33·64 months [95% CI 19·55-not reached], RVd-elotuzumab 31·47 months [18·56-53·98]; hazard ratio 0·968 [80% CI 0·697-1·344]; one-sided p=0·45]. PMID 33357482 ↗

paper the addition of elotuzumab to RVd induction and maintenance did not improve patient outcomes. PMID 33357482 ↗

Publications

• Banerjee R, Sexton R, Cowan AJ, Rosenberg AS, Ailawadhi S, Rajkumar SV, Kumar S, Dispenzieri A, Lonial S, Durie BGM, Richardson PG, Usmani SZ, Hoering A, Orlowski RZ. Dexamethasone dose intensity does not impact outcomes in newly diagnosed multiple myeloma: a secondary SWOG analysis. Blood. 2025 Jan 2;145(1):75-84. doi: 10.1182/blood.2024025939.
• Usmani SZ, Hoering A, Ailawadhi S, Sexton R, Lipe B, Hita SF, Valent J, Rosenzweig M, Zonder JA, Dhodapkar M, Callander N, Zimmerman T, Voorhees PM, Durie B, Rajkumar SV, Richardson PG, Orlowski RZ; SWOG1211 Trial Investigators. 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 Jan;8(1):e45-e54. doi: 10.1016/S2352-3026(20)30354-9. Epub 2020 Dec 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
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