NCT02272803 · REGISTRY CONDITION SEARCH

Phase II Study of Lenalidomide/Dexamethasone With or Without Elotuzumab for Newly Diagnosed MM Patients in Japan

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: 2022-06-22

The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone + Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM) in Japan.

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

Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld)

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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

Progression Free Survival (PFS) Rate

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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: * Newly diagnosed with symptomatic Multiple Myeloma (MM) * Have not received any prior systemic anti-myeloma therapy * Have measurable disease * Are not candidates for high-dose therapy plus stem-cell transplantation (SCT) because of age (≥ 65 years) or coexisting conditions. Refusal to undergo high dose therapy with SCT is NOT sufficient for entry onto CA204-116 for a subject \< 65 years old. There must be a comorbidity that prevents SCT for a subject \< 65 years old Exclusion Criteria: * Non-secretory myeloma * Smoldering MM, defined as asymptomatic MM with absence of lytic bone lesions * Monoclonal Gammopathy of Undetermined Significance (MGUS) * Active plasma cell leukemia * Known Human Immunodeficiency Virus (HIV) infection or active hepatitis A, B, or C
healthy Volunteers: false
minimum Age: 20 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Drug: Lenalidomide Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug Drug: Dexamethasone Tablets, Oral 28 mg and Intravenous (IV) 8 mg, once daily, on Days 1, 8, 15, 22 (cycles 1\&2) ; Days 1 \&15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug Tablets, Oral, 40 mg, once daily, on Days 8 \& 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug Biological: Elotuzumab (BMS-901608) Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
intervention Names
Drug: Lenalidomide
Drug: Dexamethasone
Biological: Elotuzumab (BMS-901608)
label
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)
type
EXPERIMENTAL
description
Drug: Lenalidomide Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug Drug: Dexamethasone Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
intervention Names
Drug: Lenalidomide
Drug: Dexamethasone
label
Arm B: Lenalidomide + Dexamethasone
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)
Arm B: Lenalidomide + Dexamethasone
name
Lenalidomide
type
DRUG
arm Group Labels
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)
Arm B: Lenalidomide + Dexamethasone
name
Dexamethasone
type
DRUG
arm Group Labels
Arm A: Lenalidomide + Dexamethasone + Elotuzumab (BMS-901608)
name
Elotuzumab (BMS-901608)
type
BIOLOGICAL

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 82
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
ORR is the proportion of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or PR as determined by investigator using the International Myeloma Working Group (IMWG) response criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
measure
Objective Response Rate (ORR) of Participants Treated With Elotuzumab + Lenalidomide/Dexamethasone (E-Ld)
time Frame
From first dose until documented response (assessed up to February 2017, approximately 24 months)

secondary Outcomes

description
ORR is the percentage of randomized participants who achieve a stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) as determined by investigator using the International Myeloma Working Group (IMWG) response criteria. SCR: CR and normal free light chain (FLC) ratio and no clonal cells in bone marrow; CR: Negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M-protein and urine M-protein level \< 100 mg/24 hours; PR: ≥ 50% reduction of serum M-Protein and reduction in urinary M-protein by ≥ 90% or to \< 200 mg/24 hours. In addition to the above, if present at baseline a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required.
measure
Objective Response Rate (ORR)
time Frame
From first dose until documented response, up to approximately 72 months
description
PFS is defined as the time from randomization to the date of the first documented tumor progression, as determined by the investigator using the International Myeloma Working Group (IMWG) response criteria, or to death due to any cause, provided death does not occur more than 10 weeks (2 or more assessment visits) after the last tumor assessment. Clinical deterioration will not be considered progression.
measure
Progression Free Survival (PFS)
time Frame
From randomization to the date of first documented tumor progression or death due to any cause, up to approximately 72 months
description
PFS rate is defined as the percentage of participants who have neither progressed nor died at the specified timepoints
measure
Progression Free Survival (PFS) Rate
time Frame
From randomization up to the specified timepoints, up to 3 years

Full study description

brief Summary: The purpose of this study is to determine the efficacy of Lenalidomide/Dexamethasone + Elotuzumab in the subjects with newly diagnosed, previously untreated Multiple Myeloma (MM) in Japan.

Source references

references

citation
Suzuki A, Kakugawa S, Miyoshi M, Hori M, Suzuki K, Furukawa Y, Ohta K. Soluble SLAMF7 is a predictive biomarker for elotuzumab therapy. Leukemia. 2020 Nov;34(11):3088-3090. doi: 10.1038/s41375-020-0860-7. Epub 2020 May 12. No abstract available.
pmid
32398792
type
DERIVED