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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.

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ClinicalTrials.gov Identifier: NCT02612779
Recruitment Status : Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : February 1, 2018
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Elotuzumab Drug: Pomalidomide Drug: Dexamethasone Drug: Nivolumab Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : December 18, 2015
Estimated Primary Completion Date : October 27, 2019
Estimated Study Completion Date : January 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arms and Interventions
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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: Elotuzumab
Drug: Pomalidomide
Drug: Dexamethasone
Drug: Nivolumab
Experimental: Elotuzumab + Nivolumab (EN)
Patients will receive treatment with a combination of elotuzumab and nivolumab
 Drug: Elotuzumab
Drug: Nivolumab


Outcome Measures
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Primary Outcome Measures :
  1. EPd cohort: Progression Free Survival (PFS) [ Time Frame: Approximately 5 years ]
    PFS is defined as the time from first dosing date to the date of the first documented progression per IMWG uniform criteria or death due to any cause, whichever occurs first

  2. EN Cohort: Objective Response Rate (ORR) [ Time Frame: Approximately 5 years ]
    ORR is defined as proportion of subjects with a best overall response of partial response (PR) or better


Secondary Outcome Measures :
  1. EPd Cohort: Objective Response Rate (ORR) [ Time Frame: Approximately 5 years ]
    ORR is defined as proportion of subjects with a best overall response of partial response (PR) or better

  2. EPd Cohort: Overall Survival Rate (OS) [ Time Frame: Approximately 5 years ]
    OS is defined as the time from first dosing date to the date of death from any cause. A subject who has not died will be censored at last known date alive

  3. EN Cohort: Progression Free Survival (PFS) [ Time Frame: Approximately 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02612779


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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:
FDA Safety Alerts and Recalls  This link exits the ClinicalTrials.gov site BMS Clinical Trial Patient Recruiting  This link exits the ClinicalTrials.gov site Investigator Inquiry Form  This link exits the ClinicalTrials.gov site

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT02612779     History of Changes
Other Study ID Numbers: CA204-142
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Dexamethasone
 Dexamethasone acetate
Nivolumab
Lenalidomide
Pomalidomide
Thalidomide
Elotuzumab
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones