Multiple MyelomaPhase 1NCT01393964

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

A Phase 1 study testing Lenalidomide, Dexamethasone and Elotuzumab (BMS-901608; HuLuc63) in people with Multiple Myeloma, run by Bristol-Myers Squibb at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Lenalidomide, Dexamethasone and Elotuzumab (BMS-901608; HuLuc63)
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 11 sitesUnited States
Study dates: 6 Jan 2012to 18 Jul 2016
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects with Multiple Myeloma (MM) and renal function fitting one of three categories:
Severe renal impairment: estimated creatinine clearance (CrCl) <30 ml/min, but not requiring dialysis
End-stage renal disease: requiring hemodialysis
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)

Who cannot join

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 locations and contacts

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

United States11 sites

Winship Cancer Institute, Emory University
Atlanta, Georgia, 30322
University Of Maryland
Baltimore, Maryland, 21201
Karmanos Cancer Institute
Detroit, Michigan, 48201
The University Of Texas M.D. Anderson Cancer Center
Houston, Texas, 77030
Investigative Clinical Research Of Indiana, Llc
Indianapolis, Indiana, 46260
University Of Iowa Hospitals And Clinics
Iowa City, Iowa, 52242
Tennessee Oncology, Pllc
Nashville, Tennessee, 37203
Weill Cornell Medical College
New York, New York, 10021
Mount Sinai Medical Center
New York, New York, 10029
Va Puget Sound Health Care System
Seattle, Washington, 98108
Washington University School Of Medicine
St Louis, Missouri, 63110

Other trials in United States

About this study

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

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: Multiple Myeloma
Being tested: Lenalidomide, Dexamethasone, Elotuzumab (BMS-901608; HuLuc63)
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LenalidomideDrug
Also called Revlimid®
Capsules, Oral, 15 mg, One capsule every 48 hours through Days 1-21 (Repeat every 28 days until subject meets criteria for discontinuation of study drug
DexamethasoneDrug
Also called Decadron®, Dexamethasone Intensol®, Dexpak® Taperpak®
Tablets, Oral, 28 mg weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug
DexamethasoneDrug
Also called Decadron®, Dexamethasone Intensol®, Dexpak® Taperpak®
Tablets, Oral, 40 mg, weekly, on days 8, 15 \& 22 (cycle 1); days 8 \&22 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
DexamethasoneDrug
Also called Decadron®, Dexamethasone Intensol®, Dexpak® Taperpak®
Solution, Intravenous, 8 mg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug
Elotuzumab (BMS-901608; HuLuc63)Biological
Solution, Intravenous, 10 mg/kg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug

Study groups in NCT01393964
Study group	Role	What they receive
Arm 1: Lenalidomide + Dexamethasone +Elotuzumab	Experimental	Severe Renal Impairment Receives: Drug: Lenalidomide; Drug: Dexamethasone; Biological: Elotuzumab (BMS-901608; HuLuc63)
Arm 2: Lenalidomide + Dexamethasone +Elotuzumab	Experimental	End-stage renal disease Receives: Drug: Lenalidomide; Drug: Dexamethasone; Biological: Elotuzumab (BMS-901608; HuLuc63)
Arm 3: Lenalidomide + Dexamethasone +Elotuzumab	Experimental	Normal renal function Receives: Drug: Lenalidomide; Drug: Dexamethasone; Biological: Elotuzumab (BMS-901608; HuLuc63)

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method
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 criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.
Measured: Day 1 of Cycle 1 to 28 days post dose
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
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 and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group
Measured: Day 1 of Cycle 1 to 28 days post dose

Secondary outcomes (5)

Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died
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.
Measured: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
Number of Participants With Persistent Elotuzumab Anti-drug Antibodies (ADA) and Number of Participants ADA Positive at Cycle 2 Pre-dose.
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 9-fold greater than the baseline; Persistent Positive: ADA positive at 2 or more sequential timepoints at least 12 weeks apart; Last Sample Positive: Not persistent positive and ADA Positive Sample in the last sampling timepoint; Other Positive: not persistent positive with ADA negative sample in the last sampling; ADA Negative: no ADA positive sample after the initiation of treatment.
Measured: From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years
Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests
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 50.0*10^9/L, Gr 3:<50.0 to 25.0*10^9/L, Gr 4:<25.0 to 10^9/L. Leukocytes Gr 1:<LLN to 3.0 *10^3 c/µL, Gr 2; <3.0 to 2.0 *10^3 c/µL, Gr 3: <2.0 to 1.0 *10^3 c/µL, Gr 4: <1.0 *10^3 c/µL.
Measured: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests
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*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:<LLN to 3 grams per deciliter (g/dL); Gr 2: <3.0 - 2.0 g/L; Gr 3: < 2 g/dL. Creatinine Gr 1: >1 - 1.5*baseline (BL)to >ULN - 1.5*ULN; Gr 2: >1.5 - 3.0*BL to > 1.5 - 3.0*ULN; Gr 3: >3.0*BL to > 3.0 - 6.0*ULN; Gr 4: >6.0*ULN.
Measured: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests
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; calcium (H) Gr1:>ULN - 11.5, Gr2:>11.5 - 12.5, Gr3: 12.5 - 13.5, Gr4: >13.5.
Measured: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jan 201218 Jul 2016

First posted14 Jul 2011 (estimated)
Study start6 Jan 2012
Primary completion21 Mar 2014
Study completion18 Jul 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01393964
Sponsor's protocol ID: CA204-007
Status last verified: Jun 2017
First submitted: 12 Jul 2011
Last updated: 3 Aug 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01393964
Acronym / sponsor ID: CA204-007
Conditions: Multiple Myeloma
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Collaborators: AbbVie
Study start: 6 Jan 2012 (actual)
Primary completion: 21 Mar 2014 (actual)
Study completion: 18 Jul 2016 (actual)
First posted: 14 Jul 2011 (estimated)
Results: Posted 27 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Arm 1: Lenalidomide + Dexamethasone +Elotuzumab	Experimental	Drug: Lenalidomide, Drug: Dexamethasone, Biological: Elotuzumab (BMS-901608; HuLuc63)Severe Renal Impairment
Arm 2: Lenalidomide + Dexamethasone +Elotuzumab	Experimental	Drug: Lenalidomide, Drug: Dexamethasone, Biological: Elotuzumab (BMS-901608; HuLuc63)End-stage renal disease
Arm 3: Lenalidomide + Dexamethasone +Elotuzumab	Experimental	Drug: Lenalidomide, Drug: Dexamethasone, Biological: Elotuzumab (BMS-901608; HuLuc63)Normal renal function

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LenalidomideAlso: Revlimid®Capsules, Oral, 15 mg, One capsule every 48 hours through Days 1-21 (Repeat every 28 days until subject meets criteria for discontinuation of study drug	Drug	Arm 1: Lenalidomide + Dexamethasone +Elotuzumab, Arm 2: Lenalidomide + Dexamethasone +Elotuzumab, Arm 3: Lenalidomide + Dexamethasone +Elotuzumab
DexamethasoneAlso: Decadron®, Dexamethasone Intensol®, Dexpak® Taperpak®Tablets, Oral, 28 mg weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug	Drug	Arm 1: Lenalidomide + Dexamethasone +Elotuzumab, Arm 2: Lenalidomide + Dexamethasone +Elotuzumab, Arm 3: Lenalidomide + Dexamethasone +Elotuzumab
DexamethasoneAlso: Decadron®, Dexamethasone Intensol®, Dexpak® Taperpak®Tablets, Oral, 40 mg, weekly, on days 8, 15 \& 22 (cycle 1); days 8 \&22 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug	Drug	Arm 1: Lenalidomide + Dexamethasone +Elotuzumab, Arm 2: Lenalidomide + Dexamethasone +Elotuzumab, Arm 3: Lenalidomide + Dexamethasone +Elotuzumab
DexamethasoneAlso: Decadron®, Dexamethasone Intensol®, Dexpak® Taperpak®Solution, Intravenous, 8 mg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug	Drug	Arm 1: Lenalidomide + Dexamethasone +Elotuzumab, Arm 2: Lenalidomide + Dexamethasone +Elotuzumab, Arm 3: Lenalidomide + Dexamethasone +Elotuzumab
Elotuzumab (BMS-901608; HuLuc63)Solution, Intravenous, 10 mg/kg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 \&15 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug	Biological	Arm 1: Lenalidomide + Dexamethasone +Elotuzumab, Arm 2: Lenalidomide + Dexamethasone +Elotuzumab, Arm 3: Lenalidomide + Dexamethasone +Elotuzumab

Primary outcome

Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method
Time frame: 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 criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group.
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
Time frame: 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 and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group

5 secondary outcomes

Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died
Time frame: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
Number of Participants With Persistent Elotuzumab Anti-drug Antibodies (ADA) and Number of Participants ADA Positive at Cycle 2 Pre-dose.
Time frame: From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years
Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests
Time frame: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests
Time frame: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests
Time frame: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)

Results and safety

Results posted to the registry on 27 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Elotuzumab + LD in Normal Renal Function(NRF) Participants	8	0
Elotuzumab + LD in Severe Renal Impairment(SRI) Participants	9	0
Elotuzumab + LD in End Stage Renal Disease(ESRD) Participants	9	0

Primary outcome: Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method

Time frame: Day 1 of Cycle 1 to 28 days post dose. Geometric mean (Geometric Coefficient of Variation). Unit: µg/mL

Measure	Elotuzumab + LD in Normal Renal Function (NRF) Participants n = 8	Elotuzumab + LD in Severe Renal Impairment (SRI) Participants n = 7	Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants n = 8
Value	217 (24)	226 (10)	218 (21)

Elotuzumab + LD in Normal Renal Function (NRF) Participants vs Elotuzumab + LD in Severe Renal Impairment (SRI) Participants: Ratio of Adjusted Means: 104.096 (90% CI 86.983 to 124.576), p = 0.704, ANOVA
Elotuzumab + LD in Normal Renal Function (NRF) Participants vs Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants: ratio of adjusted means: 100.454 (90% CI 84.453 to 119.488), p = 0.965, ANOVA

Population analysed: The analyses of primary endpoint of PK parameters were conducted by renal functions as determined by CrCl C-G method in those participants who were treated with at least one dose of study drug and had evaluable pre- and post-treatment values.

Primary outcome: 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

Time frame: Day 1 of Cycle 1 to 28 days post dose. Geometric mean (Geometric Coefficient of Variation). Unit: µg*h/mL

Measure	Elotuzumab + LD in Normal Renal Function (NRF) Participants n = 8	Elotuzumab + LD in Severe Renal Impairment (SRI) Participants n = 7	Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants n = 8
AUC (0-T)	39559 (28)	50080 (20)	45937 (31)
AUC (INF)	46401 (39)	60255 (31)	51227 (39)

Elotuzumab + LD in Normal Renal Function (NRF) Participants vs Elotuzumab + LD in Severe Renal Impairment (SRI) Participants: Ratio of Adjusted Means: 126.596 (90% CI 95.52 to 167.783), p = 0.164, ANOVA
Elotuzumab + LD in Normal Renal Function (NRF) Participants vs Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants: Ratio of Adjusted Means: 116.123 (90% CI 88.458 to 152.439), p = 0.355, ANOVA
Elotuzumab + LD in Normal Renal Function (NRF) Participants vs Elotuzumab + LD in Severe Renal Impairment (SRI) Participants: Ratio of Adjusted Means: 129.858 (90% CI 90.366 to 186.609), p = 0.228, ANOVA

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Elotuzumab + LD in Normal Renal Function (NRF) Participants	3 of 8 (37.5%)	8 of 8 (100%)	Not reported
Elotuzumab + LD in Severe Renal Impairment (SRI) Participants	5 of 9 (55.6%)	9 of 9 (100%)	Not reported
Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants	7 of 9 (77.8%)	9 of 9 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS clinical trial educational resourceLink provided by the sponsor.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

11 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lenalidomide, Dexamethasone and Elotuzumab (BMS-901608; HuLuc63) in people with Multiple Myeloma, run by Bristol-Myers Squibb at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method (time frame: Day 1 of Cycle 1 to 28 days post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01393964.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2017.