NCT01239797 · CITED IN SOURCE DOCUMENTS

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE3
Status at capture: COMPLETED
Registry last update: 2022-06-01

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

Median Progression Free Survival (PFS)

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outcome · POSTED

Median Progression Free Survival (PFS) - Extended Collection

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outcome · POSTED

Objective Response Rate (ORR)

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outcome · POSTED

Median Overall Survival (OS)

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outcome · POSTED

Change From Baseline of Mean Score Pain Severity (BPI-SF)

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outcome · POSTED

Change From Baseline of Mean Score Pain Interference (BPI-SF)

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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: * Documented progression from most recent line of therapy * 1-3 prior lines of therapy * Measurable disease * Life expectancy ≥3 months * Prior treatment with Lenalidomide permitted if: 1. Best response achieved was ≥Partial Response (PR) 2. Patient was not refractory 3. Patient did not discontinue due to a Grade ≥3 related adverse event 4. Subject did not receive more than 9 cycles of Lenalidomide and had at least 9 months between the last dose of Lenalidomide and progression Exclusion Criteria: * Subjects with non-secretory or oligo-secretory or serum free light-chain only myeloma * 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 (Oral)
Drug: Dexamethasone (IV)
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
On weeks without Elotuzumab dosing: Tablets, Oral, 40mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug. On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg, Repeat every 28 days until subject meets criteria for discontinuation of study drug
name
Dexamethasone (Oral)
other Names
Decadron®
Dexamethasone Intensol®
Dexpak®
Taperpak®
type
DRUG
arm Group Labels
Lenalidomide + Dexamethasone +Elotuzumab
description
On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly, Repeat every 28 days until subject meets criteria for discontinuation of study drug
name
Dexamethasone (IV)
other Names
Decadron®
Dexamethasone Intensol®
Dexpak®
Taperpak®
type
DRUG
arm Group Labels
Lenalidomide + Dexamethasone +Elotuzumab
description
Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 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: 646
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Primary definition of Progression-free survival (PFS) defined as the time from randomization to the date of first documented tumor progression or death due to any cause. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (\> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. The primary analysis of PFS was based on the primary definition using the Independent Review Committee (IRC) tumor assessment using the European Group for Blood and Bone Marrow Transplant (EBMT) criteria. Tumor assessments were made every 4 weeks (±1 week) relative to the first dose of study medication.
measure
Median Progression Free Survival (PFS)
time Frame
From randomization up to 326 events (up to approximately 38 months)
description
Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR \[sCR\], complete response \[CR\], very good partial response \[VGPR\], and partial response \[PR\]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (\> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks.
measure
Objective Response Rate (ORR)
time Frame
From randomization up to approximately 38 months

secondary Outcomes

description
Overall survival is defined as the time from randomization to the date of death from any cause. If a subject has not died, their survival time will be censored at the date of last contact ("last known alive date"). A subject will be censored at the date of randomization if they were randomized but had no follow-up. (Based on Kaplan Meier estimates)
measure
Median Overall Survival (OS)
time Frame
Randomization to the date of death from any cause (up to approximately 9 years)
description
The change from baseline of the mean score of pain severity at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
measure
Change From Baseline of Mean Score Pain Severity (BPI-SF)
time Frame
From baseline up to approximately 38 months
description
The change from baseline of the mean score of pain interference at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 ("No pain", "No interference") to 10 ("Pain as bad as you can imagine", "Highest imaginable interference") numeric rating scale.
measure
Change From Baseline of Mean Score Pain Interference (BPI-SF)
time Frame
From baseline up to approximately 38 months

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, Lonial S, Betts KA, Chen C, Zichlin ML, Brun A, Signorovitch JE, Makenbaeva D, Mekan S, Sy O, Weisel K, Richardson PG. Elotuzumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: Extended 4-year follow-up and analysis of relative progression-free survival from the randomized ELOQUENT-2 trial. Cancer. 2018 Oct 15;124(20):4032-4043. doi: 10.1002/cncr.31680. Epub 2018 Sep 11.
pmid
30204239
type
DERIVED
citation
Passey C, Mora J, Dodge R, Gibiansky L, Sheng J, Roy A, Bello A, Gupta M. An Integrated Assessment of the Effects of Immunogenicity on the Pharmacokinetics, Safety, and Efficacy of Elotuzumab. AAPS J. 2017 Mar;19(2):557-567. doi: 10.1208/s12248-016-0033-9. Epub 2017 Jan 9.
pmid
28070715
type
DERIVED
citation
Lonial S, Dimopoulos M, Palumbo A, White D, Grosicki S, Spicka I, Walter-Croneck A, Moreau P, Mateos MV, Magen H, Belch A, Reece D, Beksac M, Spencer A, Oakervee H, Orlowski RZ, Taniwaki M, Rollig C, Einsele H, Wu KL, Singhal A, San-Miguel J, Matsumoto M, Katz J, Bleickardt E, Poulart V, Anderson KC, Richardson P; ELOQUENT-2 Investigators. Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma. N Engl J Med. 2015 Aug 13;373(7):621-31. doi: 10.1056/NEJMoa1505654. Epub 2015 Jun 2.
pmid
26035255
type
DERIVED