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.

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.

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Dexamethasone; Drug: Elotuzumab; Drug: Pomalidomide; Drug: Nivolumab

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Mobile, Alabama, United States, 36607
      • Southern Cancer Center
  • California
    • Santa Barbara, California, United States, 93105
      • Sansum Clinic - USOR
  • Colorado
    • Denver, Colorado, United States, 80218
      • Colorado Blood Cancer Institute - PPDS
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers (Williams) - USOR
  • Florida
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists - EAST - SCRI - PPDS
    • Saint Petersburg, Florida, United States, 33705
      • Florida Cancer Specialists - NORTH - SCRI - PPDS
  • Illinois
    • Peoria, Illinois, United States, 61615
      • Illinois Cancer Care
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • American Oncology Partners of Maryland, PA
    • Easton, Maryland, United States, 21601
      • Bay Hematology Oncology
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48201
      • Barbara Ann Karmanos Cancer Center
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Medical Center
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Greenville Health System
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Avera Health Care
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Jones Clinic PC
    • Nashville, Tennessee, United States, 37203
      • Tennessee Oncology NASH - SCRI - PPDS
  • Texas
    • San Antonio, Texas, United States, 78217
      • Texas Oncology (LOOP) - USOR
  • Virginia
    • Leesburg, Virginia, United States, 20176
      • Virginia Cancer Specialists (Leesburg) - USOR
  • Washington
    • Seattle, Washington, United States, 98104
      • Swedish Medical Center
    • Spokane Valley, Washington, United States, 99216
      • Cancer Care Northwest
  • Wisconsin
    • Burlington, Wisconsin, United States, 53105
      • Aurora Health Care

Participation Criteria

Eligibility Criteria

• 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:

1. All subjects must have documented disease progression per IMWG criteria during or after their last anti-myeloma therapy.
2. ECOG Performance Status less than or equal to 2
3. 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.

4. 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.

5. 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:

1. Subjects with solitary bone or extramedullary plasmacytoma as the only evidence of plasma cells dyscrasia
2. 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)
3. Subjects with Central Nervous System involvement with multiple myeloma

Other protocol defined inclusion/exclusion criteria could apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd); patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression.	Drug: Dexamethasone; Drug: Elotuzumab; Drug: Pomalidomide; Drug: Nivolumab
Experimental: Elotuzumab + Nivolumab (EN); Patients will receive treatment with a combination of elotuzumab and nivolumab	Drug: Elotuzumab; Drug: Nivolumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	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.	From first dose to study completion date (up to approximately 50 months)
Objective Response Rate (ORR)	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.	From first dose to study completion date (up to approximately 50 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS)	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.	From first dose to study completion date (up to approximately 50 months)
Objective Response Rate (ORR)	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.	From first dose to study completion date (up to approximately 50 months)
Overall Survival (OS)	OS is defined as the time from first dosing date to the date of death from any cause.	From first dose to study completion date (up to approximately 50 months)

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2016
• Primary Completion (Actual): July 29, 2019
• Study Completion (Actual): June 12, 2020

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Actual): July 2, 2021
• Last Update Submitted That Met QC Criteria: June 10, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Immunological; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Immune Checkpoint Inhibitors; Dexamethasone; Pomalidomide; Nivolumab; Elotuzumab
• Other Study ID Numbers: CA204-142

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No