Clinical trial NCT01393964: Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function
Official title: PH Ib 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2011-07-14
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients with very low kidney function including patients on dialysis.


Eligibility criteria: Inclusion Criteria:

* Subjects with Multiple Myeloma (MM) and renal function fitting one of three categories:

  1. Severe renal impairment: estimated creatinine clearance (CrCl) \<30 ml/min, but not requiring dialysis
  2. End-stage renal disease: requiring hemodialysis
  3. Normal renal function: estimated CrCl ≥90 ml/min
* Documented evidence of symptomatic MM, either newly diagnosed or relapsed/refractory
* Prior Lenalidomide exposure is permitted only if the subject did not discontinue Lenalidomide due to a Grade ≥3 related Adverse Event (AE)

Exclusion Criteria:

* Monoclonal Gammopathy of Undetermined Significance (MGUS), Waldenstrom's macroglobulinemia, or smoldering myeloma
* Active plasma cell leukemia
* All adverse events of any prior chemotherapy, surgery, or radiotherapy not resolved
* POEMS syndrome (plasma cell dyscrasia with polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
* Acute renal failure

Primary outcomes:
measure: Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method
timeFrame: Day 1 of Cycle 1 to 28 days post dose
measure: Geometric Mean Area Under Serum Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) and From Time Zero Extrapolated to Infinite Time AUC(INF) of Elotuzumab Following Cycle 1, Day 1 - Grouping by C-G CrCl Method
timeFrame: Day 1 of Cycle 1 to 28 days post dose
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died
timeFrame: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
measure: Number of Participants With Persistent Elotuzumab Anti-drug Antibodies (ADA) and Number of Participants ADA Positive at Cycle 2 Pre-dose.
timeFrame: From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years
measure: Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests
timeFrame: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
measure: Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests
timeFrame: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
measure: Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests
timeFrame: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
Other outcomes:
measure: Mean Terminal-phase Elimination Half-life (T-Half) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method
timeFrame: Day 1 of Cycle 1 to 28 days post dose
measure: Median Time to Maximal Concentration (Tmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method
timeFrame: Day 1 of Cycle 1 to 28 days post dose
measure: Geometric Mean Total Body Clearance (CLT) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method
timeFrame: Day 1 of Cycle 1 to 28 days post dose
measure: Geometric Mean Apparent Volume of Distribution (Vz) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method
timeFrame: Day 1 of Cycle 1 to 28 days post dose
Locations:
city: Atlanta
country: United States
facility: Winship Cancer Institute, Emory University
state: Georgia
city: Indianapolis
country: United States
facility: Investigative Clinical Research Of Indiana, Llc
state: Indiana
city: Iowa City
country: United States
facility: University Of Iowa Hospitals And Clinics
state: Iowa
city: Baltimore
country: United States
facility: University Of Maryland
state: Maryland
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Nashville
country: United States
facility: Tennessee Oncology, Pllc
state: Tennessee
city: Houston
country: United States
facility: The University Of Texas M.D. Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Va Puget Sound Health Care System
state: Washington
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: