Clinical trial · Interventional
Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Various Levels of Renal Function
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
NCT01393964CI-TRIAL-00028926completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to assess the concentration of Elotuzumab in Myeloma patients with very low kidney function including patients on dialysis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Elotuzumab (BMS-901608; HuLuc63) | Biological | Elotuzumab | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm 1: Lenalidomide + Dexamethasone +Elotuzumab
- description
- Severe Renal Impairment
- interventionNames
- Drug: Lenalidomide
- Drug: Dexamethasone
- Biological: Elotuzumab (BMS-901608; HuLuc63)
- type
- EXPERIMENTAL
- label
- Arm 2: Lenalidomide + Dexamethasone +Elotuzumab
- description
- End-stage renal disease
- interventionNames
- Drug: Lenalidomide
- Drug: Dexamethasone
- Biological: Elotuzumab (BMS-901608; HuLuc63)
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.