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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


Phase 1
18 Years
N/A
Open (Enrolling by invite only)
Both
Multiple Myeloma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum plasma concentration (Cmax) of Elotuzumab

Outcome Time Frame:

Within the first 28 days after the first dose on Day 1 of Cycle 1

Safety Issue:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CA204-007

NCT ID:

NCT01393964

Start Date:

January 2012

Completion Date:

April 2015

Related Keywords:

  • Multiple Myeloma
  • Kidney Failure, Chronic
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Mount Sinai Medical CenterNew York, New York  10029
VA Puget Sound Health Care SystemSeattle, Washington  98101
University of MarylandBaltimore, Maryland  21201
The University of Texas M.D. Anderson Cancer CenterHouston, Texas  
Karmanos Cancer InstituteDetroit, Michigan  48201
Winship Cancer Institute, Emory UniversityAtlanta, Georgia  30322
Tennessee Oncology, PLLCClarksville, Tennessee  37043
Weill Cornell Medical CollegeNew York, New York  10021