NCT03411031 · REGISTRY CONDITION SEARCH

Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on 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: TERMINATED
Registry last update: 2023-03-29

The purpose of this study is determine Time-to-Progression with elotuzumab plus lenalidomide when elotuzumab is added to multiple myeloma participants with serologic relapse/progression while receiving lenalidomide maintenance for each study arm.

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

Percentage of Participants With Progression Free Survival (PFS)

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outcome · POSTED

Overall Response

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outcome · POSTED

Minimum Response (MR)

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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: * Patients with multiple myeloma who demonstrate evidence of serologic relapse/progression while on lenalidomide maintenance given as part of first line therapy (including upfront high-dose chemotherapy followed by autologous hematopoietic cell transplantation (HCT)) without symptomatic relapse/progression. Lenalidomide maintenance is defined as single agent lenalidomide therapy of any doses up to 10 mg PO daily for up to 28 days (28-day cycle). * Male or female patients aged ≥ 18 years old * Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed * Measurable disease as outlined in protocol guidelines * Participants must meet laboratory criteria as outlined in protocol guidelines Exclusion Criteria: * Prior Elotuzumab * Patients with clinical relapse/progression as per the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma defined as one or more of the following criteria: * Development of new soft tissue plasmacytomas or bone lesions (osteoporotic fractures do not constitute progression) * Definite increase in the size of existing plasmacytomas or bone lesions. A definite increase is defined as a 50% (and ≥1 cm) increase as measured serially of the measurable lesion * Hypercalcemia (\>11 mg/dL); * Decrease in hemoglobin of ≥2 g/dL not related to therapy or other non-myeloma-related conditions; * Rise in serum creatinine by 2 mg/dL or more from the start of the therapy and attributable to myeloma * Hyperviscosity related to serum paraprotein * Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not using an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy testing within 7 days prior to the administration of drug. * Male patients whose sexual partners are WOCBP not using effective birth control * Patients with a prior malignancy with in the last 5 years (except for basal or squamous cell carcinoma, or in situ cancer of the cervix) * Patients with known positivity for human immunodeficiency virus (HIV)) or hepatitis C; baseline testing for HIV and hepatitis C is not required * Patients with a diagnosis of POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes) or plasma cell leukemia (\> 2.0 × 10\^9/L circulating plasma cells by standard differential)
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Elotuzumab 10 mg/kg intravenously (IV) weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab. Lenalidomide 25 mg by mouth (PO) daily days 1-21 out of a 28-day schedule.
intervention Names
Drug: Elotuzumab
Drug: Lenalidomide
Drug: Dexamethasone
label
A: Elotuzumab + Lenalidomide at 25 mg
type
ACTIVE_COMPARATOR
description
Elotuzumab 10 mg/kg IV weekly (days 1, 8, 15 and 22) for 2 cycles, then 20 mg/kg every 4 weeks. Dexamethasone will be administered as premedication for elotuzumab. Lenalidomide 10 mg PO daily days 1-21 out of a 28-day schedule.
intervention Names
Drug: Elotuzumab
Drug: Lenalidomide
Drug: Dexamethasone
label
B: Elotuzumab + Lenalidomide at 10 mg
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
A: Elotuzumab + Lenalidomide at 25 mg
B: Elotuzumab + Lenalidomide at 10 mg
description
Elotuzumab according to dosing schedule outlined in treatment arms.
name
Elotuzumab
other Names
Empliciti™
BMS-901608
HuLuc63
type
DRUG
arm Group Labels
A: Elotuzumab + Lenalidomide at 25 mg
B: Elotuzumab + Lenalidomide at 10 mg
description
Lenalidomide according to dosing schedule outlined in treatment arms.
name
Lenalidomide
other Names
REVLIMID®
thalidomide analogue
type
DRUG
arm Group Labels
A: Elotuzumab + Lenalidomide at 25 mg
B: Elotuzumab + Lenalidomide at 10 mg
description
Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information. During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert.
name
Dexamethasone
other Names
Decadron
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 18
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Progression free survival (PFS) is defined as the time of randomization to date of death from any cause, date of relapse/progression, or the last follow-up date, whichever comes first. The Kaplan-Meier method will be used to estimate PFS for each Study Arm. The method of Brookmeyer and Crowley will be used to construct 95% confidence interval.
measure
Percentage of Participants With Progression Free Survival (PFS)
time Frame
An average of 8 months

secondary Outcomes

description
Overall response with elotuzumab and lenalidomide for each study arm. Overall Response is defined as best Overall Response, as Complete Response or Partial Response. Response will be assessed per the uniform response criteria of the International Myeloma Working Group(IMWG). Myeloma participants enrolled in this clinical study will be assessed for disease response after every cycle. Complete Response= Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow aspirates; Partial Response= ≥50% reduction of serum M-protein plus reduction in 24 h urinary M-protein by ≥90% or to \<200 mg per 24 h;
measure
Overall Response
time Frame
Up to 60 days post last study treatment
description
Minimum response (MR) or better with elotuzumab and lenalidomide for each study arm. The Consensus on Uniform Reporting of Response will be used to evaluate response. Myeloma participants enrolled in this clinical study will be assessed for disease response after every cycle.
measure
Minimum Response (MR)
time Frame
Up to 60 days post last study treatment

Full study description

brief Summary: The purpose of this study is determine Time-to-Progression with elotuzumab plus lenalidomide when elotuzumab is added to multiple myeloma participants with serologic relapse/progression while receiving lenalidomide maintenance for each study arm.
detailed Description: This is a randomized parallel 2-cohort phase 2 study of elotuzumab given at 10 mg/kg weekly during induction in combination with lenalidomide (either 25 mg or 10 mg) in patients with multiple myeloma who progress or relapse serologically while on single agent lenalidomide maintenance. The combination therapy with elotuzumab and lenalidomide will be continued until further progression of myeloma (based on response criteria) or intolerability.

Source references