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

Completed · Phase 1/Phase 2

Conditions studied: DS Stage I Plasma Cell Myeloma, DS Stage II Plasma Cell Myeloma, DS Stage III Plasma Cell Myeloma

In brief

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.

Key facts

Study ID

NCT01668719

Run by

SWOG Cancer Research Network

People needed

142

Starts

2012-11-01

Expected to finish

2025-09-22

Last updated by the study team

2026-04-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must have newly diagnosed active multiple myeloma (MM)
• For the Phase II portion only, patients must have high-risk MM based on one or more of the following criteria at the time of initial diagnosis (prior to any chemotherapy):
• Poor-risk genomic signature according to the University of Arkansas 70-gene model (available clinically as myeloma prognostic risk score [MyPRS] score, Signal Genetics, Inc) AND/OR
• Translocation (14;16), and/or translocation (14;20), and/or deletion (17p) by fluorescence in-situ hybridization (FISH) or cytogenetics AND/OR
• Primary plasma cell leukemia (defined by either >= 2,000 plasma cells/mL of peripheral blood, or 20% on a manual differential count) AND/OR
• Serum lactate dehydrogenase (LDH) >= 2 x institutional upper limit of normal (IULN) AND/OR
• 1q21 amplification by FISH analysis AND/OR
• High risk by the SKY92 signature
• Patients with non-secretory MM or known amyloidosis are not eligible
• Patients must have measurable disease within 28 days prior to registration (or prior to initiation of first induction course for patients with prior therapy)
• Patients on the Phase I portion may not have received ANY prior chemotherapy; patients on the Phase II portion may have received one prior cycle of any non-investigational chemotherapy; prior chemotherapy must have been completed within 56 days prior to registration and all toxicities must have resolved to =< grade 1; patients on either portion may have received prior treatment with dexamethasone, providing total number of days of treatment was =< 14 days and total treatment dose was =< 360 mg
• Patients may have received prior radiotherapy for symptomatic localized bone lesions or impending spinal cord compression only; radiotherapy must be completed at least 14 days prior to registration and all toxicities must have resolved to =< grade 1
• Absolute neutrophil count (ANC) >= 1,000 cells/mm\^3 without growth factor support
• Platelet count >= 70,000 cells/mm\^3 for patients who have bone marrow plasmacytosis < 50%; or >= 50,000 cells/mm\^3 for patients who have bone marrow plasmacytosis of >= 50%
• Total bilirubin =< 1.5 x institutional upper limit of normal (IULN)
• Serum glutamic oxaloacetic transaminase (SGOT)/aspartate aminotransferase (AST) and serum glutamate pyruvate transaminase (SGPT)/alanine aminotransferase (ALT) =< 2.5 x IULN
• Creatinine clearance (CrCL) >= 30 mL/min, measured by a 24-hour urine collection or estimated by the Cockcroft and Gault formula within 14 days prior to registration
• Patients must not have active involvement of the central nervous system (CNS) with MM (by clinical evaluation); patients with documentation of, or clinical signs or symptoms consistent with, CNS involvement of MM must have a lumbar puncture that is negative for CNS involvement of MM; the lumbar puncture must be completed within 14 days prior to registration; patients with no previous history of documented CNS involvement and with no clinical signs or symptoms consistent with CNS involvement are not required to have completed a lumbar puncture prior to registration; note that monitoring of CNS involvement and treatment with intrathecal therapy is recommended during protocol treatment
• Patients who are known to be human immunodeficiency virus positive (HIV+) are eligible providing they meet all of the following additional criteria within 28 days prior to registration:
• Cluster of differentiation (CD)4 cells >= 500/mm\^3
• Viral load of < 50 copies HIV messenger ribonucleic acid (mRNA)/mm\^3 if on combination antiretroviral therapy (cART) or < 25,000 copies HIV mRNA if not on cART
• No zidovudine or stavudine as part of cART
• Patients who are HIV+ and do not meet all of these criteria are not eligible for this study
• Patients must have baseline skeletal survey (whole body x-ray) to document lytic lesions, osteopenia or compression fracture
• Patients must have Zubrod performance status =< 2

Where it is running

• Alaska Women's Cancer Care — Anchorage, Alaska, United States
• Anchorage Oncology Centre — Anchorage, Alaska, United States
• Katmai Oncology Group — Anchorage, Alaska, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Providence Saint Joseph Medical Center/Disney Family Cancer Center — Burbank, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Los Angeles County-USC Medical Center — Los Angeles, California, United States
• USC / Norris Comprehensive Cancer Center — Los Angeles, California, United States
• UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
• Smilow Cancer Hospital-Derby Care Center — Derby, Connecticut, United States
• Smilow Cancer Hospital Care Center-Fairfield — Fairfield, Connecticut, United States
• Medical Oncology and Hematology Group PC-Guilford — Guilford, Connecticut, United States
• Smilow Cancer Hospital Care Center at Saint Francis — Hartford, Connecticut, United States
• The Hospital of Central Connecticut — New Britain, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Yale-New Haven Hospital North Haven Medical Center — North Haven, Connecticut, United States
• Smilow Cancer Hospital-Orange Care Center — Orange, Connecticut, United States
• Charlotte Hungerford Hospital Center for Cancer Care — Torrington, Connecticut, United States
• Smilow Cancer Hospital Care Center-Trumbull — Trumbull, Connecticut, United States
• Smilow Cancer Hospital-Waterbury Care Center — Waterbury, Connecticut, United States
• Beebe Medical Center — Lewes, Delaware, United States
• Christiana Gynecologic Oncology LLC — Newark, Delaware, United States
• Delaware Clinical and Laboratory Physicians PA — Newark, Delaware, United States
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States

Full record on ClinicalTrials.gov

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