NCT01393964 is a Phase 1 clinical trial of Lenalidomide in Multiple Myeloma, sponsored by Bristol-Myers Squibb.

Who is sponsoring NCT01393964?

NCT01393964 is sponsored by Bristol-Myers Squibb.

What drugs are being tested in NCT01393964?

Interventions in NCT01393964: Lenalidomide, Dexamethasone, Dexamethasone, Dexamethasone, Elotuzumab (BMS-901608; HuLuc63).

What condition does NCT01393964 study?

NCT01393964 studies Multiple Myeloma.

Is NCT01393964 still recruiting?

NCT01393964 is currently completed. Last updated 3 August 2017.

Are results published for NCT01393964?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-08-03 · How we verify

NCT01393964

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Results posted Last updated 3 August 2017

What this trial tests

Phase 1 trial testing Lenalidomide in Multiple Myeloma in 35 participants. Completed in 18 July 2016.

Timeline

6 January 2012

Primary endpoint
21 March 2014

18 July 2016

Quick facts

Lead sponsor	Bristol-Myers Squibb
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	6 January 2012
Primary completion	21 March 2014
Estimated completion	18 July 2016
Sites	11 locations across United States

Drugs / interventions tested

Lenalidomide — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →
Elotuzumab (BMS-901608; HuLuc63) — full drug profile →

Conditions studied

Multiple Myeloma — all drugs for Multiple Myeloma →

Sponsor

Bristol-Myers Squibb — full company profile →

Who can join

18 and older, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method Primary · Day 1 of Cycle 1 to 28 days post dose

The quantification of elotuzumab in human serum was performed using a validated Enzyme-linked immunoassay (ELISA). Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Cmax was measured in micrograms per milliliter (µg/mL). Pharmacokinetic (PK) parameter renal function group assignment

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	217	± 24
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	226	± 10
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	218	± 21

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 Primary · Day 1 of Cycle 1 to 28 days post dose

The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD participants had 2 additional sample times: immediately prior to and immediately after dialysis. AUC was measured in µg\*h/mL. PK parameter renal function group assignment criteria differed slightly from the criteria for safety

AUC (0-T)

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	39559	± 28
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	50080	± 20
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	45937	± 31

AUC (INF)

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	46401	± 39
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	60255	± 31
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	51227	± 39

Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died Secondary · From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)

AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

Deaths

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	0
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	0
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	0

Any SAE

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	3
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	5
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	7

AEs Leading to Discontinuation

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	1
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	4
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	1

Number of Participants With Persistent Elotuzumab Anti-drug Antibodies (ADA) and Number of Participants ADA Positive at Cycle 2 Pre-dose. Secondary · From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years

Serum samples were evaluated for the presence of ADAs using a validated bridging electrochemiluminescence (ECL) immunoassay. Samples in: Cycle 1, Day 1 0 h (pre-dose), Cycle 2, Day 1(Study Day 29), 0 h (pre-dose; 672 h post-dose), Cycle 3, Day 1, 0 h and in cycle thereafter, at end of study/discontinuation, and at 30 and 60 day follow up visits post treatment. ADA Positive Participant: baseline negative with at least one ADA positive sample at any time after initiation of treatment or baseline positive with at least one ADA positive sample at any time after initiation of treatment with a titer

Baseline ADA Positive

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	1
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	0
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	0

On-Study ADA Positive

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	2
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	1
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	1

Positive at Cycle 2 pre-dose

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	2
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	0
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	1

Persistent Positive

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	0
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	0
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	0

Last Sample Positive

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	1
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	0
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	1

Other Positive

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	1
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	1
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	0

On-Study ADA Negative

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	4
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	3
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	5

Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests Secondary · From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)

National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:\<LLN to 10.0 g/dL, Gr 2:\<10.0 to 8.0 g/dL, Gr 3:\<8.0 to 6.5 g/dL, Gr 4:\<6.5 g/dL. Lymphocytes absolute (abs) Gr 1: \<1.5 to 0.8 \*10\^3 c/µL, Gr 2 \<0.8 to 0.5 \*10\^3 c/µL, Gr 3: \<0.5 to 0.2 \*10\^3 c/µL, Gr 4: \<0.2\*10\^3 c/µL. Neutrophils abs: Gr 1:\<LLN to 1.5\*10\^9/L, Gr 2:\<1.5 to 1.0\*10\^9/L, Gr 3:\<1.0 to 0.5\*10\^9/L, Gr 4:\<0.5\*10\^9/L. Platelet count Gr 1:LLN to 75.0\*10\^9/L, Gr 2:\<75.0 to 50.

Hemoglobin Any Grade

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	8
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	9
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	9

Hemoglobin Grade 3-4

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	0
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	2
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	6

Platelet Count Any Grade

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	7
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	8
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	8

Platelet Count Grade 3-4

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	0
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	2
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	2

Leukocytes Any Grade

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	8
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	8
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	6

Leukocytes Grade 3-4

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	3
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	1
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	2

Lymphocytes (Abs) Any Grade

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	8
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	9
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	9

Lymphocytes (Abs) Grade 3-4

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	6
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	9
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	5

Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests Secondary · From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)

NCI CTCAE, version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:\>1.0 to 2.5\*ULN; Gr 2: \>2.5 to 5.0\*ULN; Gr 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. AST Gr 1: \>1.0 to 2.5\*ULN; Gr 2: \>2.5 to 5.0\*ULN; Gr 3: \>5.0 to 20.0\*ULN; Gr 4: \>20.0\*ULN. Total bilirubin Gr 1: \>1.0 to 1.5\*ULN; Gr 2: \>1.5 to 3.0\*ULN; Gr 3: \>3.0 to 10..0\*ULN; Gr 4: \>10.0.0\*ULN. ALP (U/L) Gr1:\>1.0 to 2.5\*ULN, Gr2:\>2.5 to 5.0\*ULN, Gr3:\>5.0 to 20.0

ALP Any Grade

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	0
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	3
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	7

ALP Grade 3-4

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	0
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	0
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	0

AST Any Grade

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	3
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	2
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	5

AST Grade 3-4

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	0
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	0
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	0

ALT Any Grade

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	2
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	5
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	5

ALT Grade 3-4

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	0
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	0
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	0

Bilirubin Any Grade

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	1
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	1
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	2

Bilirubin Grade 3-4

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	0
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	0
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	0

Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests Secondary · From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)

Sodium high (H) Gr 1:\>ULN - 150; Gr 2: \>150 - 155; Gr 3: \>155 - 160; Gr 4: \>160 mmol/L; Sodium low(L) Gr 1:\<LLN - 130; Gr 3: \<130 - 120; Gr 4: \<120 mmol/L. Potassium (H) Gr 1: \>ULN - 5.5; Gr 2: \>5.5 - 6.0; Gr 3: \> 6.0 - 7.0; Gr 4: \>7.0 mmol/L; Potassium (L) Gr 1: \<LLN - 3.0; Gr 2: \<LLN - 3.0; Gr 3: \< 3.0 - 2.5; Gr 4: \<2.5 mmol/L. Bicarbonate Gr1: 16-\<LLN, Gr2: 11-16, Gr3, 8-11, Gr4: \<8 milliequivalents per liter (mEq/L). Phosphorus Gr 1: 2.5 - \<LLN, Gr2 2.0-\<2.5, Gr3: 1.0-\<2.0, Gr4: \<1.0. Calcium (L) Gr 1: \<LLN to 8.0; Gr2: 7.0 - 8.0; Gr3: 6.0-7.0; Gr 4: \<6.0 mg/dL; calc

Sodium High Any Grade

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	2
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	3
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	2

Sodium High Grade 3-4

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	0
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	0
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	0

Sodium Low Any Grade

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	2
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	6
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	5

Sodium Low Grade 3-4

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	1
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	1
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	0

Potassium High Any Grade

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	2
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	2
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	4

Potassium High Grade 3-4

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	0
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	0
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	3

Potassium Low Any Grade

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	2
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	5
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	6

Potassium Low Grade 3-4

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	0
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	2
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	1

Mean Terminal-phase Elimination Half-life (T-Half) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method Secondary · Day 1 of Cycle 1 to 28 days post dose

The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. T-Half was measured in hours (h). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	204	± 134.11
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	237	± 107.88
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	218	± 98.87

Median Time to Maximal Concentration (Tmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method Secondary · Day 1 of Cycle 1 to 28 days post dose

The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Tmax was measured in hours (h). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy ana

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	3.23	2.9 – 4.9
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	3.87	2.8 – 6.8
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	3.33	2.82 – 25.92

Geometric Mean Total Body Clearance (CLT) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method Secondary · Day 1 of Cycle 1 to 28 days post dose

The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. CLT was measured in mL per hour per kilogram body weight (mL/h/kg). PK parameter renal function group assignment criteria differed slightly from the

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	0.215	± 46
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	0.166	± 28
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	0.195	± 54

Geometric Mean Apparent Volume of Distribution (Vz) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method Secondary · Day 1 of Cycle 1 to 28 days post dose

The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Vz was measured in mL per kilogram body weight (mL/kg). PK parameter renal function group assignment criteria differed slightly from the criteria for

Group	Value	95% CI
Elotuzumab + LD in Normal Renal Function (NRF) Participants	59.4	± 30
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	54.6	± 20
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	61.2	± 43

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Elotuzumab + LD in Normal Renal Function (NRF) Participants

Serious: 3/8 (38%)

Deaths: —

Elotuzumab + LD in Severe Renal Impairment (SRI) Participants

Serious: 5/9 (56%)

Deaths: —

Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants

Serious: 7/9 (78%)

Deaths: —

Serious adverse events (36 terms)

Reaction	System	Elotuzumab + LD in Normal …	Elotuzumab + LD in Severe …	Elotuzumab + LD in End Sta…
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—
Pneumonia	Infections and infestations	—	—	—
Anaemia macrocytic	Blood and lymphatic system disorders	—	—	—
Atrial fibrillation	Cardiac disorders	—	—	—
Bradycardia	Cardiac disorders	—	—	—
Tachycardia	Cardiac disorders	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Chest discomfort	General disorders	—	—	—
Chest pain	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Cholecystitis	Hepatobiliary disorders	—	—	—
Bronchitis	Infections and infestations	—	—	—
Clostridium difficile infection	Infections and infestations	—	—	—
Gastroenteritis salmonella	Infections and infestations	—	—	—
Influenza	Infections and infestations	—	—	—
Meningitis bacterial	Infections and infestations	—	—	—
Pneumonia respiratory syncytial viral	Infections and infestations	—	—	—
Sepsis	Infections and infestations	—	—	—
Soft tissue infection	Infections and infestations	—	—	—
Staphylococcal bacteraemia	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Blood creatinine increased	Investigations	—	—	—
Influenza a virus test positive	Investigations	—	—	—

Other adverse events (227 terms — click to expand)

Reaction	System	Elotuzumab + LD in Normal …	Elotuzumab + LD in Severe …	Elotuzumab + LD in End Sta…
Fatigue	General disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Blood creatinine increased	Investigations	—	—	—
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Oedema peripheral	General disorders	—	—	—
Pyrexia	General disorders	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—
Syncope	Nervous system disorders	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—
Vision blurred	Eye disorders	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—
Malaise	General disorders	—	—	—
Urinary tract infection	Infections and infestations	—	—	—
Contusion	Injury, poisoning and procedural complications	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—
Hypocalcaemia	Metabolism and nutrition disorders	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—
Dizziness	Nervous system disorders	—	—	—
Insomnia	Psychiatric disorders	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—
Pruritus	Skin and subcutaneous tissue disorders	—	—	—
Leukopenia	Blood and lymphatic system disorders	—	—	—
Lymphopenia	Blood and lymphatic system disorders	—	—	—
Tachycardia	Cardiac disorders	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—
Asthenia	General disorders	—	—	—

Most-reported serious reactions: Febrile neutropenia, Pneumonia, Anaemia macrocytic, Atrial fibrillation, Bradycardia, Tachycardia, Hypothyroidism, Abdominal pain.

Data from ClinicalTrials.gov NCT01393964 adverse events section.

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Elotuzumab for the treatment of multiple myeloma.
Wang Y, Sanchez L, Siegel DS, Wang ML. · · 2016 · cited 41× · PMID 27417553 · DOI 10.1186/s13045-016-0284-z
Immunotherapy: A Novel Era of Promising Treatments for Multiple Myeloma.
Castella M, Fernández de Larrea C, Martín-Antonio B. · · 2018 · cited 25× · PMID 30445802 · DOI 10.3390/ijms19113613
Treatment of multiple myeloma with the immunostimulatory SLAMF7 antibody elotuzumab.
Einsele H, Schreder M. · · 2016 · cited 16× · PMID 27695618 · DOI 10.1177/2040620716657993
Spotlight on elotuzumab in the treatment of multiple myeloma: the evidence to date.
Weisel K. · · 2016 · cited 11× · PMID 27785050 · DOI 10.2147/ott.s94531
Population pharmacokinetic and exposure-response analyses of elotuzumab plus pomalidomide and dexamethasone for relapsed and refractory multiple myeloma.
Ide T, Osawa M, Sanghavi K, Vezina HE. · · 2022 · cited 3× · PMID 34825942 · DOI 10.1007/s00280-021-04365-4

Verify or expand the search:

Other trials of Lenalidomide

Trials testing the same drug.

NCT07428369 — A Study of Linvo-VR vs DVRd in Transplant-Eligible Adult Participants With Newly Diagnosed Multiple Myeloma (NDMM) · Phase 2, PHASE3 · not yet recruiting
NCT07247097 — ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred · Phase 2 · not yet recruiting
NCT07465029 — A Study of Incidence, Treatment Patterns, and Outcomes in Transfusion-dependent Lower-risk Myelodysplastic Syndromes in · active not recruiting
NCT07261163 — Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma · Phase 2 · not yet recruiting
NCT06910124 — Linvoseltamab in Addition to Lenalidomide (L2) During Maintenance Therapy of NDMM to Deepen Responses or Redrive MRD Neg · Phase 2 · recruiting

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

NCT07200102 — Selinexor Maintenance Post CAR-T Cell Therapy for Multiple Myeloma · Phase 1 · recruiting
NCT07340853 — CRISPR Delivered Anti-BCMA Car-T Therapy for Relapsed or Refractory Multiple Myeloma · Phase 1 · recruiting
NCT07454382 — A Study of Elranatamab and Cyclophosphamide in People With Multiple Myeloma · Phase 2 · recruiting
NCT07266441 — A Study of JNJ-79635322 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 2 · recruiting
NCT07258511 — A Study Comparing JNJ-79635322 and an Anti-B-cell Maturation Antigen (BCMA)xCD3 Bispecific Antibody in Participants With · Phase 3 · recruiting

Other Bristol-Myers Squibb trials

Trials by the same sponsor.

NCT07441408 — Long-term Extension Study to Evaluate Safety and Tolerability of Admilparant in Participants With Pulmonary Fibrosis · Phase 3 · not yet recruiting
NCT07459543 — A Study To Assess the Safety, and Tolerability of Nivolumab + Relatlimab Fixed-Dose Combination (FDC) In Untreated, Unre · Phase 4 · not yet recruiting
NCT07285798 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder · Phase 3 · not yet recruiting
NCT07284745 — A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism · Phase 3 · not yet recruiting
NCT07492680 — A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic S · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01393964 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bristol-Myers Squibb
Last refreshed: 3 August 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01393964.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01393964

Quick facts

Drugs / interventions tested

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Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (36 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Lenalidomide

Other recruiting trials for Multiple Myeloma

Other Bristol-Myers Squibb trials

Verify against primary sources