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.

Multiple Myeloma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612779
• Other study ID #: CA204-142
• Status: Completed
• Phase: Phase 2
• Start date: February 9, 2016
• Est. completion date: June 12, 2020

Study information

• Verified date: June 2021
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: June 12, 2020
• Est. primary completion date: July 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Elotuzumab

• Pomalidomide

• Dexamethasone

• Nivolumab

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	American Oncology Partners of Maryland, PA	Bethesda	Maryland
United States	Aurora Health Care	Burlington	Wisconsin
United States	Colorado Blood Cancer Institute - PPDS	Denver	Colorado
United States	Rocky Mountain Cancer Centers (Williams) - USOR	Denver	Colorado
United States	Barbara Ann Karmanos Cancer Center	Detroit	Michigan
United States	Bay Hematology Oncology	Easton	Maryland
United States	Jones Clinic PC	Germantown	Tennessee
United States	Greenville Health System	Greenville	South Carolina
United States	Virginia Cancer Specialists (Leesburg) - USOR	Leesburg	Virginia
United States	Southern Cancer Center	Mobile	Alabama
United States	Tennessee Oncology NASH - SCRI - PPDS	Nashville	Tennessee
United States	Mount Sinai Medical Center	New York	New York
United States	Illinois Cancer Care	Peoria	Illinois
United States	Washington University	Saint Louis	Missouri
United States	Florida Cancer Specialists - EAST - SCRI - PPDS	Saint Petersburg	Florida
United States	Florida Cancer Specialists - NORTH - SCRI - PPDS	Saint Petersburg	Florida
United States	Texas Oncology (Loop) - USOR	San Antonio	Texas
United States	Sansum Clinic - USOR	Santa Barbara	California
United States	Swedish Medical Center	Seattle	Washington
United States	Avera Health Care	Sioux Falls	South Dakota
United States	Cancer Care Northwest	Spokane Valley	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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	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)
Secondary	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)

External Links

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