Clinical Trial Details for Study "GCC 1146"

Official Title: A Phase 1b Study of Elotuzumab in Combination with Lenalidomide and Dexamethasone in Subjects with Multiple Myeloma and Normal Renal Function, Severe Renal Impairment, or End Stage Renal Disease Requiring Dialysis
Investigator: Ashraf Badros, M.D.
Summary: This is a Phase 1b, open-label, multi-center trial investigating lenalidomide/dexamethasone with and without elotuzumab in subjects with multiple myeloma (MM) and normal renal function, severe RI, or ESRD requiring dialysis. A normal renal function group is included as an internal control. The purpose of this study is to determine if severe kidney impairment and end-stage kidney disease affects how one's body processes elotuzumab. Earlier studies show that elotuzumab given with lenalidomide and dexamethasone has a favorable safety report in patients with normal renal function or mild and moderate kidney impairment. It is unknown whether the same is true for patients who have severe kidney impairment or are dialysis dependent. This study will also look at the safety of elotuzumab given with lenalidomide and dexamethasone in patients with and without severe kidney impairment and end-stage kidney disease requiring dialysis. This is a study of the effects of severe kidney impairment and end-stage kidney disease on elotuzumab in patients with multiple myeloma. Eligible patients who agree to be in this study will take lenalidomide and dexamethasone with elotuzumab.
Disease site: Hematologic Malignancies,Multiple Myeloma
Disease stage: Normal, Severe, End Stage
Condition: Renal Disease
Intervention: Elotuzumab in Combination with Lenalidomide and Dexamethasone
Phase: 1b
Study number: GCC 1146
Eligibility*
(inclusion criteria)
    Subject is, in the investigators opinion, willing and able to comply with the protocol requirements; a) Subjects with MM and renal function fitting one of three categories defined by the protocol; Renal function must be stable based on a repeat creatinine measurement and reestimation of CrCl by Cockcroft-Gault at least 24 hours after the first measurement and estimation, within the 14 day screening period; valuable or measurable (by IMWG) disease; Subjects must be willing to refrain from blood donations during study drug therapy and for 90 days after therapy; 18 years of age or greater; Not pregnant or breastfeeding.
(exclusion criteria)
    MGUS, Waldenstroms macroglobulinemia, or smoldering myeloma; Active plasma cell leukemia as defined by the protocol; Prior cerebrovascular event with persistent neurologic deficit; Major surgery within 4 weeks, minor surgery within 2 weeks, or radiation therapy within 2 weeks before enrollment as defined by the protocol; Current use of a non standard dialysis membrane; Women of childbearing potential who are pregnant or lactating or unwilling to use 2 forms of effective birth control; Prisoners or subjects who are involuntarily incarcerated.
Contact Person
 Sunita Philip, MS 410-328-8199
Pat Lesho, RN 410-328-2577
* Note: This study may include eligibility criteria that are not listed here. For more information about the study or to find out if you are eligible, call 1-800-888-8823.


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