NCT02612779 · REGISTRY CONDITION SEARCH

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.

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2021-07-02

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Progression Free Survival (PFS)

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outcome · POSTED

Overall Survival (OS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
patients will receive treatment with elotuzumab in combination with pomalidomide and low-dose dexamethasone. Patients are eligible to receive Nivolumab at progression.
intervention Names
Drug: Elotuzumab
Drug: Pomalidomide
Drug: Dexamethasone
Drug: Nivolumab
label
Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)
type
EXPERIMENTAL
description
Patients will receive treatment with a combination of elotuzumab and nivolumab
intervention Names
Drug: Elotuzumab
Drug: Nivolumab
label
Elotuzumab + Nivolumab (EN)
type
EXPERIMENTAL

interventions

arm Group Labels
Elotuzumab + Nivolumab (EN)
Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)
name
Elotuzumab
type
DRUG
arm Group Labels
Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)
name
Pomalidomide
type
DRUG
arm Group Labels
Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)
name
Dexamethasone
type
DRUG
arm Group Labels
Elotuzumab + Nivolumab (EN)
Elotuzumab + Pomalidamide + Low Dose Dexamethasone (EPd)
name
Nivolumab
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 74
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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.
measure
Progression Free Survival (PFS)
time Frame
From first dose to study completion date (up to approximately 50 months)
description
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.
measure
Objective Response Rate (ORR)
time Frame
From first dose to study completion date (up to approximately 50 months)

secondary Outcomes

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

Full study description

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.

Source references