NCT02252263

Brief Summary

To assess the safety and tolerability, characterize the dose limiting toxicities (DLTs) and identify the maximally tolerated dose (MTD) of Elotuzumab administered in combination with either Lirilumab or Urelumab in subjects with multiple myeloma.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for phase_1 multiple-myeloma

Timeline
Completed

Started Dec 2014

Geographic Reach
2 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 26, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

December 9, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2017

Completed
Last Updated

November 1, 2017

Status Verified

October 1, 2017

Enrollment Period

2.8 years

First QC Date

September 26, 2014

Last Update Submit

October 30, 2017

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Safety as measured by the rate of AEs, SAEs, deaths is the primary endpoint of this Phase 1 study. All subjects who receive at least one (full or partial) dose of Elotuzumab, Lirilumab or Urelumab will be evaluated for safety

    adverse events (AEs), serious adverse events (SAEs)

    During treatment and first 100 days after treatment

Secondary Outcomes (20)

  • Best Overall Response (BOR)

    At different timepoints approximately up to 2.5 years

  • Objective Response rate (ORR)

    At different timepoints approximately up to 2.5 years

  • Median Duration of Response (mDOR)

    At different timepoints approximately up to 2.5 years

  • Median Time to Response (mTTR)

    At different timepoints approximately up to 2.5 years

  • Progression-free survival rate (PFSR)

    At different timepoints approximately up to 2.5 years

  • +15 more secondary outcomes

Study Arms (2)

Arm 1: Elotuzumab + Lirilumab

EXPERIMENTAL

Elotuzumab weekly for 8 wks and every 2 wks thereafter + Lirilumab every 4 wks Intravenous solution for Up to 2 yrs, depending on response

Drug: ElotuzumabDrug: Lirilumab

Arm 2: Elotuzumab + Urelumab

EXPERIMENTAL

Elotuzumab weekly for 8 wks and every 2 wks thereafter + Urelumab every 4 wks Intravenous solution for Up to 26 weeks, depending on response

Drug: ElotuzumabDrug: Urelumab

Interventions

ElotuzumabDRUG
Also known as: BMS-901608
Arm 1: Elotuzumab + LirilumabArm 2: Elotuzumab + Urelumab
LirilumabDRUG
Also known as: BMS-986015
Arm 1: Elotuzumab + Lirilumab
UrelumabDRUG
Also known as: BMS-663513
Arm 2: Elotuzumab + Urelumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must have histological confirmation of multiple myeloma with measurable disease (per International Myeloma Working Group (IMWG) criteria):
  • Relapsed/refractory multiple myeloma, subjects who are post autologous transplant and have achieved very good partial response (VGPR) or complete response (nCR) with minimal residual disease (MRD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

University Of Arkansas For Medical Sciences

Little Rock, Arkansas, United States

Location

The Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, 21287, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University Of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Local Institution

Pamplona, Navarre, 31008, Spain

Location

Related Links

MeSH Terms

Conditions

Multiple Myeloma

Interventions

elotuzumablirilumaburelumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 26, 2014

First Posted

September 30, 2014

Study Start

December 9, 2014

Primary Completion

October 10, 2017

Study Completion

October 10, 2017

Last Updated

November 1, 2017

Record last verified: 2017-10

Locations

US(6)ES(1)