NCT01335399 · REGISTRY CONDITION SEARCH

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Newly Diagnosed, Previously Untreated 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: 2022-09-30

The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)

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

Overall Survival (OS)

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outcome · POSTED

Mean Change From Baseline of Pain Severity Score and Pain Interference Score

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outcome · POSTED

Progression Free Survival (PFS) Rate at Specific Time-points

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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: * Subjects who are newly diagnosed with symptomatic Multiple Myeloma (MM) and who: * have not received any prior systemic anti-myeloma therapy AND * have measurable disease AND * 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 CA204006 for a subject \< 65 years old. There must be a comorbidity that prevents SCT for a subject \< 65 years old Exclusion Criteria: * Subjects with non-secretory or oligo-secretory or free light-chain only 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: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

intervention Names
Drug: Lenalidomide
Drug: Dexamethasone
label
Lenalidomide + Dexamethasone
type
ACTIVE_COMPARATOR
intervention Names
Drug: Lenalidomide
Drug: Dexamethasone
Biological: Elotuzumab (BMS-901608; HuLuc63)
label
Lenalidomide + Dexamethasone + Elotuzumab
type
EXPERIMENTAL

interventions

arm Group Labels
Lenalidomide + Dexamethasone
Lenalidomide + Dexamethasone + Elotuzumab
description
Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
name
Lenalidomide
other Names
Revlimid®
type
DRUG
arm Group Labels
Lenalidomide + Dexamethasone
description
Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
name
Dexamethasone
other Names
Decadron®
Dexamethasone Intensol®
Dexpak®
Taperpak®
type
DRUG
arm Group Labels
Lenalidomide + Dexamethasone + Elotuzumab
description
Tablets, Oral, 28 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
name
Dexamethasone
other Names
Decadron®
Dexamethasone Intensol®
Dexpak®
Taperpak®
type
DRUG
arm Group Labels
Lenalidomide + Dexamethasone + Elotuzumab
description
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
name
Dexamethasone
other Names
Decadron®
Dexamethasone Intensol®
Dexpak®
Taperpak®
type
DRUG
arm Group Labels
Lenalidomide + Dexamethasone + Elotuzumab
description
Solution, 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
name
Dexamethasone
other Names
Decadron®
Dexamethasone Intensol®
Dexpak®
Taperpak®
type
DRUG
arm Group Labels
Lenalidomide + Dexamethasone + Elotuzumab
description
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
name
Elotuzumab (BMS-901608; HuLuc63)
type
BIOLOGICAL
arm Group Labels
Lenalidomide + Dexamethasone + Elotuzumab
description
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
name
Elotuzumab (BMS-901608; HuLuc63)
type
BIOLOGICAL

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 748
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause. The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Censoring rules applied: * Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy. * Participants who had an event (progression or death) \> 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event. * Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment. * Participants without any post-baseline tumor assessments were censored on the date of randomization
measure
Progression-Free Survival (PFS)
time Frame
From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)

secondary Outcomes

description
ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria.
measure
Objective Response Rate (ORR)
time Frame
From randomization to primary completion date (approximately 8 years)
description
Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive").
measure
Overall Survival (OS)
time Frame
From randomization to the date of death (up to 8 years)
description
Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF). BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine).
measure
Mean Change From Baseline of Pain Severity Score and Pain Interference Score
time Frame
From Baseline to End of Treatment (approximately 8 years)
description
PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points.
measure
Progression Free Survival (PFS) Rate at Specific Time-points
time Frame
From randomization to the specified time-point (up to 5 years)

Full study description

brief Summary: The purpose of the study is to determine whether the addition of Elotuzumab to Lenalidomide/low-dose Dexamethasone will increase the progression free survival (PFS)

Source references

references

citation
Dimopoulos MA, Richardson PG, Bahlis NJ, Grosicki S, Cavo M, Beksac M, Legiec W, Liberati AM, Goldschmidt H, Belch A, Magen H, Larocca A, Laubach JP, Petrucci MT, Reece D, White D, Mateos MV, Spicka I, Lazaroiu M, Berdeja J, Kaufman JL, Jou YM, Ganetsky A, Popa McKiver M, Lonial S, Weisel K; ELOQUENT-1 investigators. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2022 Jun;9(6):e403-e414. doi: 10.1016/S2352-3026(22)00103-X. Epub 2022 May 9.
pmid
35550060
type
DERIVED