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

NCT03411031 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: MCC-19197NCI-2018-00891
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

lenalidomide maintenance; hematopoietic cell transplantation; serologic relapse

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Progression Free Survival (PFS)

  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 Outcomes (2)

• Overall Response

  Up to 60 days post last study treatment

• Minimum Response (MR)

  Up to 60 days post last study treatment

Study Arms (2)

A: Elotuzumab + Lenalidomide at 25 mg

ACTIVE COMPARATOR

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; Drug: Lenalidomide; Drug: Dexamethasone

B: Elotuzumab + Lenalidomide at 10 mg

ACTIVE COMPARATOR

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; Drug: Lenalidomide; Drug: Dexamethasone

Interventions

Elotuzumab DRUG

Elotuzumab according to dosing schedule outlined in treatment arms.

Also known as: Empliciti™, BMS-901608, HuLuc63

A: Elotuzumab + Lenalidomide at 25 mg; B: Elotuzumab + Lenalidomide at 10 mg

Lenalidomide DRUG

Lenalidomide according to dosing schedule outlined in treatment arms.

Also known as: REVLIMID®, thalidomide analogue

A: Elotuzumab + Lenalidomide at 25 mg; B: Elotuzumab + Lenalidomide at 10 mg

Dexamethasone 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.

Also known as: Decadron

A: Elotuzumab + Lenalidomide at 25 mg; B: Elotuzumab + Lenalidomide at 10 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

• Moffitt Cancer Center Clinical Trials website

MeSH Terms

Conditions

Multiple Myeloma

Interventions

elotuzumab; Lenalidomide; Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dr. Melissa Alsina
• Organization: Moffitt Cancer Center

Melissa.Alsina@moffitt.org

813-745-7202

Study Officials

• Melissa Alsina, M.D.

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2018
• First Posted: January 25, 2018
• Study Start: October 4, 2018
• Primary Completion: February 18, 2021
• Study Completion: November 4, 2021
• Last Updated: March 29, 2023
• Results First Posted: April 14, 2022

Record last verified: 2023-03

Locations

US (1)