Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide

March 28, 2023 updated by: H. Lee Moffitt Cancer Center and Research Institute

A Randomized Parallel Phase 2 Study of Elotuzumab Plus Lenalidomide (Elo/Rev) for the Treatment of Serologic Relapse/Progression While on Lenalidomide Maintenance for Multiple Myeloma

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A: Elotuzumab + Lenalidomide at 25 mg

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.
Drug: Elotuzumab
Elotuzumab according to dosing schedule outlined in treatment arms.
Other Names:
  • BMS-901608
  • HuLuc63
  • Empliciti™
Drug: Lenalidomide
Lenalidomide according to dosing schedule outlined in treatment arms.
Other Names:
  • REVLIMID®
  • thalidomide analogue
Drug: Dexamethasone

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.

Other Names:
  • Decadron
Active Comparator: B: Elotuzumab + Lenalidomide at 10 mg

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.
Drug: Elotuzumab
Elotuzumab according to dosing schedule outlined in treatment arms.
Other Names:
  • BMS-901608
  • HuLuc63
  • Empliciti™
Drug: Lenalidomide
Lenalidomide according to dosing schedule outlined in treatment arms.
Other Names:
  • REVLIMID®
  • thalidomide analogue
Drug: Dexamethasone

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.

Other Names:
  • Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Progression Free Survival (PFS)
Time Frame: An average of 8 months
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.
An average of 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response
Time Frame: Up to 60 days post last study treatment
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;
Up to 60 days post last study treatment
Minimum Response (MR)
Time Frame: Up to 60 days post last study treatment
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.
Up to 60 days post last study treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

Bristol-Myers Squibb

Investigators

  • Principal Investigator: Melissa Alsina, M.D., H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2018

Primary Completion (Actual)

February 18, 2021

Study Completion (Actual)

November 4, 2021

Study Registration Dates

First Submitted

January 19, 2018

First Submitted That Met QC Criteria

January 24, 2018

First Posted (Actual)

January 25, 2018

Study Record Updates

Last Update Posted (Actual)

March 29, 2023

Last Update Submitted That Met QC Criteria

March 28, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-19197
  • NCI-2018-00891 (Other Identifier: NCI)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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