A Phase I Open Label Study of the Safety and Tolerability of Elotuzumab (BMS-901608) Administered in Combination With Either Lirilumab (BMS-986015) or Urelumab (BMS-663513) in Subjects With Multiple Myeloma

October 30, 2017 updated by: Bristol-Myers Squibb

A Phase I Open Label Dose Escalation and Randomized Cohort Expansion Study of the Safety and Tolerability of Elotuzumab (BMS-901608) Administered in Combination With Either Lirilumab (BMS-986015) or Urelumab (BMS-663513) in Subjects With Multiple Myeloma

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Allocation:

  • Part1: Non-randomized
  • Part2: Randomized

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Local Institution
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
        • University of Arkansas for Medical Sciences
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • The Sidney Kimmel Comprehensive Cancer Center
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The Ohio State University
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: Elotuzumab + Lirilumab
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: Elotuzumab
Other Names:
  • BMS-901608
Drug: Lirilumab
Other Names:
  • BMS-986015
Experimental: Arm 2: Elotuzumab + Urelumab
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: Elotuzumab
Other Names:
  • BMS-901608
Drug: Urelumab
Other Names:
  • BMS-663513

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time Frame: During treatment and first 100 days after treatment
adverse events (AEs), serious adverse events (SAEs)
During treatment and first 100 days after treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Best Overall Response (BOR)
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Objective Response rate (ORR)
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Median Duration of Response (mDOR)
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Median Time to Response (mTTR)
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Progression-free survival rate (PFSR)
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
M-protein levels
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Minimal Residual Disease (MRD) status for Post Autologous Transplant subjects
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Maximum concentration of Urelumab (Cmax)
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Maximum concentration of Lirilumab (Cmax)
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Area under the Curve (AUCTAU) of Urelumab
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Area under the Curve (AUCTAU) of Lirilumab
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Volume of distribution (Vz) for Urelumab
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Total Clearance (CLT) of Urelumab
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Total Clearance (CLT) of Lirilumab
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Urelumab
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Elotuzumab
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Concentration at the end of infusion (ceoinf) of Lirilumab
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Cmin will be capture at steady state of all study subjects
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
Occurence of Specific anti-drug antibodies (ADA) to each study drug
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years
ADA status of the subject Biomarkers: NK and T cell numbers, Phenotypic and functional measures in cohort expansion subjects
Time Frame: At different timepoints approximately up to 2.5 years
At different timepoints approximately up to 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 10, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 10, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA223-028

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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