Skip to main content
OpenTrials
Completed

NCT Number: NCT02612779

A Study of Elotuzumab in Combination With Pomalidomide and Low Dose Dexamethasone and Elotuzumab in Combination With Nivolumab in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.

Study of elotuzumab in combination with pomalidomide and low dose dexamethasone (EPd Cohort) and elotuzumab in combination with nivolumab (EN Cohort) to assess the safety and efficacy of these combination therapies for treatment of relapsed or refractory MM patients.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Southern Cancer Center, Mobile, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Inclusion criteria

  • All subjects must have documented disease progression per IMWG criteria during or after their last anti-myeloma therapy.
  • ECOG Performance Status less than or equal to 2
  • Subject Re-enrollment: This study permits the re-enrollment of a subject that has discontinued the study as a pre-treatment failure (ie, has not been treated). If re-enrolled, the subject must be re-consented.
  • EPd Cohort:
  • must have received at least 1 but no greater than 2 prior lines of therapy (note: induction and stem cell transplants with or without maintenance therapy is considered 1 line of therapy)
  • Subjects must have received prior treatment with a lenalidomide-containing regimen for at least 2 consecutive cycles (full therapeutic dose) and must have been deemed as relapsed, refractory, or intolerant. Refractory is defined as progressing on-treatment or within 60 days of the last dose.
  • EN Cohort:
  • Subjects must have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory (IMID) agent OR were double-refractory to both an IMID and a PI. Refractory is defined as progressing on-treatment or within 60 days of the last dose.

Exclusion criteria

  • Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia
  • Subjects with monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma (SMM), primary amyloidosis, Waldenstrom's macroglobulinemia, or POEMS syndrome (plasma cell dyscrasia with poly neuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
  • Subjects with Central Nervous System involvement with multiple myeloma

Other protocol defined inclusion/exclusion criteria could apply.

Treatment and study plan

Elotuzumab

Drug

Pomalidomide

Drug

Dexamethasone

Drug

Nivolumab

Drug

Primary outcomes

  1. Progression Free Survival (PFS)

    Time frame: From first dose to study completion date (up to approximately 50 months)

    PFS is defined as the time from first dosing date to the date of the first documented progression or death due to any cause, whichever occurs first.

    Progression is determined per International Myeloma Working Group (IMWG) uniform criteria.

    Participants who die without a reported prior progression were considered to have progressed on the date of their death.

    Participants who did not progress or die were censored on the date of their last evaluable assessment. Participants who did not have any on study efficacy assessments and did not die were censored on the first dosing date.

    Participants who switched to subsequent therapy prior to documented progression were censored on the date of the last evaluable assessment prior to the initiation of the new therapy.

  2. Objective Response Rate (ORR)

    Time frame: From first dose to study completion date (up to approximately 50 months)

    ORR is defined as the percent of participants with best overall response of partial response (PR) or better. Response is determined per IMWG uniform criteria.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: From first dose to study completion date (up to approximately 50 months)

    ORR is defined as the percent of participants with best overall response of partial response (PR) or better. Response is determined per IMWG uniform criteria.

  2. Progression Free Survival (PFS)

    Time frame: From first dose to study completion date (up to approximately 50 months)

    PFS is defined as the time from first dosing date to the date of the first documented progression or death due to any cause, whichever occurs first.

    Progression is determined per International Myeloma Working Group (IMWG) uniform criteria.

    Participants who die without a reported prior progression were considered to have progressed on the date of their death.

    Participants who did not progress or die were censored on the date of their last evaluable assessment. Participants who did not have any on study efficacy assessments and did not die were censored on the first dosing date.

    Participants who switched to subsequent therapy prior to documented progression were censored on the date of the last evaluable assessment prior to the initiation of the new therapy.

  3. Overall Survival (OS)

    Time frame: From first dose to study completion date (up to approximately 50 months)

    OS is defined as the time from first dosing date to the date of death from any cause.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 2, Multiple Cohort Study of Elotuzumab in Combination With Pomalidomide and Low-Dose Dexamethasone (EPd), and in Combination With Nivolumab (EN), in Patients With Multiple Myeloma Relapsed or Refractory to Prior Treatment With Lenalidomide.

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Nov 24, 2015
Registry last updated
Jul 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.