Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagn… (NCT01335399) | Clinical Trial Compass
CompletedPhase 3
Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated Multiple Myeloma
United States748 participantsStarted 2011-08-04
Plain-language summary
The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who:
* have not received any prior systemic anti-myeloma therapy AND
* have measurable disease AND
* are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204006 for a subject \< 65 years old. There must be a comorbidity that prevents SCT for a subject \< 65 years old
Exclusion Criteria:
* Subjects with non-secretory or oligo-secretory or free light-chain only myeloma
* Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions
* Monoclonal Gammopathy of Undetermined Significance (MGUS)
* Active plasma cell leukemia
* Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
What they're measuring
1
Progression-Free Survival (PFS)
Timeframe: From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)