NCT02726581 · REGISTRY CONDITION SEARCH

An Investigational Immuno-therapy Study of Nivolumab, Pomalidomide and Dexamethasone Combinations in Patients With Multiple Myeloma

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

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2023-03-27

The purpose of this study is to evaluate the safety and effectiveness of several combination therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized (assigned by chance) to receive either: Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone. Enrollment is closed for all groups.

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

Overall Survival (OS)

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Time to Objective Response (TTR)

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outcome · POSTED

Duration of Objective Response (DOR)

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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: Inclusion Criteria: * Refractory or relapsed and refractory multiple myeloma * Measurable disease * Have received ≥ 2 lines of prior therapy which must have included an immune modulatory drug (IMiD) and a proteasome inhibitor alone or in combination Exclusion Criteria: * Solitary bone or extramedullary plasmacytoma disease only * Active plasma cell leukemia Other protocol defined inclusion/exclusion criteria apply
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Nivolumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
intervention Names
Biological: Nivolumab
Drug: Pomalidomide
Drug: Dexamethasone
label
Investigational Arm
type
EXPERIMENTAL
description
Pomalidomide and Dexamethasone Enrollment is closed for this arm
intervention Names
Drug: Pomalidomide
Drug: Dexamethasone
label
Control Arm
type
ACTIVE_COMPARATOR
description
Nivolumab, Elotuzumab, Pomalidomide and Dexamethasone Enrollment is closed for this arm
intervention Names
Biological: Nivolumab
Biological: Elotuzumab
Drug: Pomalidomide
Drug: Dexamethasone
label
Exploratory Arm
type
EXPERIMENTAL

interventions

arm Group Labels
Exploratory Arm
Investigational Arm
description
Specified dose on specified days, IV (intravenous)
name
Nivolumab
other Names
BMS-936558
type
BIOLOGICAL
arm Group Labels
Exploratory Arm
description
Specified dose on specified days, IV
name
Elotuzumab
other Names
BMS-901608
type
BIOLOGICAL
arm Group Labels
Control Arm
Exploratory Arm
Investigational Arm
description
Specified dose on specified days, PO (by mouth)
name
Pomalidomide
type
DRUG
arm Group Labels
Control Arm
Exploratory Arm
Investigational Arm
description
Specified dose on specified days, PO
name
Dexamethasone
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 170
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Randomization to first documented tumor progression or death due to any cause, whichever occurred first. Participants who die without reported prior progression are considered to have progressed on date of their death. Participants who did not progress or die will be censored at their last efficacy assessment. Participants who did not have on study efficacy assessments and alive will be censored on randomization date. Participants who started subsequent anti-cancer therapy without prior reported progression will be censored at last efficacy assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), \>/= 50% increase from nadir in SPD of \> 1 lesion, or \>/= 50% increase in the longest diameter of a previous lesion \> 1 cm in short axis.
measure
Progression Free Survival (PFS)
time Frame
From randomization to the date of the first documented tumor progression or death due to any cause, whichever occurred first (Up to approximately 64 month)

secondary Outcomes

description
The time between the date of randomization and the date of death due to any cause. OS will be censored on the last date a participant was known to be alive.
measure
Overall Survival (OS)
time Frame
From randomization to the date of death due to any cause (up to approximately 64 months)
description
The percentage of randomized participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) using International Myeloma Working Group (IMWG) criteria. sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates. VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h. PR = \>/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by \>/= 90% or to \< 200 mg per 24 h.
measure
Objective Response Rate (ORR)
time Frame
From randomization up to approximately 64 months
description
The time from the date of randomization to the date of the first stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). sCR= Complete response as defined below plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry. CR = Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow aspirates. VGPR = Serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>/= 90% reduction in serum M-protein plus urine M-protein level \< 100 mg per 24 h. PR = \>/= 50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by \>/= 90% or to \< 200 mg per 24 h.
measure
Time to Objective Response (TTR)
time Frame
From the date of randomization to the date of the first sCR, CR, VGPR, or PR (up to approximately 64 months)
description
The time between the date of first response to the date of the first objectively documented tumor progression as assessed by the investigator according to International Myeloma Working Group (IMWG) criteria or death due to any cause prior to subsequent anti-cancer therapy. Participants who neither progress nor die will be censored on the date of their last tumor assessment prior to subsequent anti-cancer therapy. Progression is 1) increase of 25% from lowest confirmed response value in specific Serum M-protein and Urine M-protein criteria and increase of FLC for patients with no measurable M protein in blood or urine at baseline and/or 2) appearance of a new lesion(s), \>/= 50% increase from nadir in SPD of \> 1 lesion, or \>/= 50% increase in the longest diameter of a previous lesion \> 1 cm in short axis.
measure
Duration of Objective Response (DOR)
time Frame
From randomization to the date of the first objectively documented tumor progression or death due to any cause prior to subsequent anti-cancer therapy (up to approximately 64 months)

Full study description

brief Summary: The purpose of this study is to evaluate the safety and effectiveness of several combination therapies for Multiple Myeloma. Upon entry into the study, patients will be randomized (assigned by chance) to receive either: Group 1: nivolumab, pomalidomide and dexamethasone OR Group 2: pomalidomide and dexamethasone OR Group 3: nivolumab, elotuzumab, pomalidomide and dexamethasone. Enrollment is closed for all groups.

Source references