E-PRISM: Phase II Trial of Elotuzumab Lenalidomide and Dexamethasone in High-Risk Smoldering Multiple Myeloma

Completed · Phase 2

Conditions studied: Smoldering Myeloma, Smoldering Multiple Myeloma

In brief

This research study is aimed to determine the proportion of high risk smoldering multiple myeloma patients who are progression free at 2 years after receiving elotuzumab, lenalidomide and dexamethasone combination therapy.

Key facts

Study ID

NCT02279394

Run by

Dana-Farber Cancer Institute

People needed

51

Starts

2014-12-11

Expected to finish

2022-01-26

Last updated by the study team

2023-06-09

Who can join

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

You may qualify if…

• Age ≥ 18 years
• Must have smoldering myeloma with high risk markers based on the Mayo OR the Spanish criteria as described below
• >10% plasma cells in the bone marrow and any one or more of the following:
• Serum M protein of 3 g/dL or greater
• IgA SMM
• Immunoparesis with reduction of two uninvolved immunoglobulin isotypes
• Serum involved/uninvolved free light chain ratio ≥8 (but less than 100)
• Progressive increase in M protein level (Evolving type of SMM)†
• Bone marrow clonal plasma cells 50-60%
• Abnormal plasma cell immunophenotype (≥95% of bone marrow plasma cells are clonal) and reduction of one or more uninvolved immunoglobulin isotypes
• t (4;14) or del 17p or 1q gain
• Increased circulating plasma cells
• MRI with diffuse abnormalities or 1 focal lesion
• PET-CT with focal lesion with increased uptake without underlying osteolytic bone destruction † Increase in serum monoclonal protein by ≥25% on two successive evaluations within a 6 month period
• No evidence of CRAB (see below for details) criteria or new criteria of active multiple myeloma which including the following:
• Increased calcium levels (corrected serum calcium >0.25 mmol/dL above the upper limit of normal or >.275 mmol/dL)
• Renal insufficiency (attributable to myeloma)
• Anemia (Hb 2g/dL below the lower limit of normal or <10g/dL)
• Bone lesions (lytic lesions or generalized osteoporosis with compression fractures)
• No evidence of the following new criteria for active MM including the following: Bone marrow plasma cells ≥ 60%, Serum involved/uninvolved FLC ratio ≥100, and MRI with more than one focal lesion
• Participants with CRAB criteria that are attributable to conditions other than the disease under study may be eligible
• ECOG Performance Status (PS) 0, 1, or 2 (Appendix A)
• The following laboratory values obtained ≤ 14 days prior to registration:
• ANC ≥1000/µL
• PLT ≥ 50,000/µL

Where it is running

• Colorado Blood Cancer Institute — Denver, Colorado, United States
• St Francis Hospital and Medical Center — Hartford, Connecticut, United States
• University of Chicago — Chicago, Illinois, United States
• Eastern Maine Medical Center — Brewer, Maine, United States
• University of Maryland — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Barbara Ann Karmanos Cancer Institute — Detroit, Michigan, United States
• Levine Cancer Institute — Charlotte, North Carolina, United States

Full record on ClinicalTrials.gov

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