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

NCT ID: NCT03411031

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-04
• Study Completion Date: 2021-11-04

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.

Conditions

Multiple Myeloma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Elotuzumab

Intervention Type: DRUG

Elotuzumab according to dosing schedule outlined in treatment arms.

Lenalidomide

Intervention Type: DRUG

Lenalidomide according to dosing schedule outlined in treatment arms.

Dexamethasone

Intervention Type: DRUG

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.

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.

Group Type: ACTIVE_COMPARATOR

Elotuzumab

Intervention Type: DRUG

Elotuzumab according to dosing schedule outlined in treatment arms.

Lenalidomide

Intervention Type: DRUG

Lenalidomide according to dosing schedule outlined in treatment arms.

Dexamethasone

Intervention Type: DRUG

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.

Interventions

Elotuzumab

Elotuzumab according to dosing schedule outlined in treatment arms.

Intervention Type: DRUG

Lenalidomide

Lenalidomide according to dosing schedule outlined in treatment arms.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Empliciti™; BMS-901608; HuLuc63; REVLIMID®; thalidomide analogue; Decadron

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Melissa Alsina, M.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NCI-2018-00891

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-19197

Identifier Type: -

Identifier Source: org_study_id