Clinical trial 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-11-24
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Progression Free Survival (PFS)
timeFrame: From first dose to study completion date (up to approximately 50 months)
measure: Objective Response Rate (ORR)
timeFrame: From first dose to study completion date (up to approximately 50 months)
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From first dose to study completion date (up to approximately 50 months)
measure: Progression Free Survival (PFS)
timeFrame: From first dose to study completion date (up to approximately 50 months)
measure: Overall Survival (OS)
timeFrame: From first dose to study completion date (up to approximately 50 months)
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Southern Cancer Center
state: Alabama
city: Santa Barbara
country: United States
facility: Sansum Clinic - USOR
state: California
city: Denver
country: United States
facility: Colorado Blood Cancer Institute - PPDS
state: Colorado
city: Denver
country: United States
facility: Rocky Mountain Cancer Centers (Williams) - USOR
state: Colorado
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - EAST - SCRI - PPDS
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists - NORTH - SCRI - PPDS
state: Florida
city: Peoria
country: United States
facility: Illinois Cancer Care
state: Illinois
city: Bethesda
country: United States
facility: American Oncology Partners of Maryland, PA
state: Maryland
city: Easton
country: United States
facility: Bay Hematology Oncology
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Center
state: Michigan
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Health Care
state: South Dakota
city: Germantown
country: United States
facility: Jones Clinic PC
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology NASH - SCRI - PPDS
state: Tennessee
city: San Antonio
country: United States
facility: Texas Oncology (Loop) - USOR
state: Texas
city: Leesburg
country: United States
facility: Virginia Cancer Specialists (Leesburg) - USOR
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: Spokane Valley
country: United States
facility: Cancer Care Northwest
state: Washington
city: Burlington
country: United States
facility: Aurora Health Care
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: