Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Multiple Myeloma

Treatments: Drug: Dexamethasone; Biological: Elotuzumab (BMS-901608; HuLuc63); Drug: Lenalidomide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01393964

CA204-007

Details and patient eligibility

About

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

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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35 participants in 3 patient groups

Arm 1: Lenalidomide + Dexamethasone +Elotuzumab

Experimental group

Description:

Severe Renal Impairment

Treatment:

Drug: Dexamethasone

Biological: Elotuzumab (BMS-901608; HuLuc63)

Drug: Dexamethasone

Drug: Lenalidomide

Drug: Dexamethasone

Arm 2: Lenalidomide + Dexamethasone +Elotuzumab

Experimental group

Description:

End-stage renal disease

Treatment:

Drug: Dexamethasone

Biological: Elotuzumab (BMS-901608; HuLuc63)

Drug: Dexamethasone

Drug: Lenalidomide

Drug: Dexamethasone

Arm 3: Lenalidomide + Dexamethasone +Elotuzumab

Experimental group

Description:

Normal renal function

Treatment:

Drug: Dexamethasone

Biological: Elotuzumab (BMS-901608; HuLuc63)

Drug: Dexamethasone

Drug: Lenalidomide

Drug: Dexamethasone