Active, Not Recruiting
PH III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Previously Untreated Multiple Myeloma (ELO 1 Substudy) - CA204-006 (Biomarker Substudy)
Updated:
16 January, 2018
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ClinicalTrials.gov
Phase
Gender(s)
Age Range
Active, Not Recruiting
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: Subjects who are newly diagnosed with symptomatic MM and who: - Have not received any prior systemic anti-myeloma therapy - 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 CA204-006 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
If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information
466-DK-2200001