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.

Phase 2

Completed

• Conditions: Multiple Myeloma
• Interventions: Drug: Elotuzumab; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Nivolumab

• Registration Number: NCT02612779
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-20
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-24
• Study Start: 2016-02-09
• Primary Completion: 2019-07-29
• Study Completion: 2020-06-12
• Results First Submitted: 2020-07-23
• Results First Submitted QC: 2020-07-23
• Results First Posted: 2020-08-06
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-10
• Last Update Posted: 2021-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	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.
Objective Response Rate (ORR)	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 Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	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.
Progression Free Survival (PFS)	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.
Overall Survival (OS)	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.

Trial Locations

Locations (22)

Southern Cancer Center; 🇺🇸 Mobile, Alabama, United States

Sansum Clinic - USOR; 🇺🇸 Santa Barbara, California, United States

Colorado Blood Cancer Institute - PPDS; 🇺🇸 Denver, Colorado, United States

Rocky Mountain Cancer Centers (Williams) - USOR; 🇺🇸 Denver, Colorado, United States

Florida Cancer Specialists - EAST - SCRI - PPDS; 🇺🇸 Saint Petersburg, Florida, United States

Florida Cancer Specialists - NORTH - SCRI - PPDS; 🇺🇸 Saint Petersburg, Florida, United States

Illinois Cancer Care; 🇺🇸 Peoria, Illinois, United States

American Oncology Partners of Maryland, PA; 🇺🇸 Bethesda, Maryland, United States

Bay Hematology Oncology; 🇺🇸 Easton, Maryland, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

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