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

Sponsor
H. Lee Moffitt Cancer Center and Research Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03411031
Collaborator
Bristol-Myers Squibb (Industry)
18
Enrollment
1
Location
2
Arms
53.9
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Oct 4, 2018
Actual Primary Completion Date :
Feb 18, 2021
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

ArmIntervention/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:
  • Empliciti™
  • BMS-901608
  • HuLuc63
  • 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:
  • Empliciti™
  • BMS-901608
  • HuLuc63
  • 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
  • Outcome Measures

    Primary Outcome Measures

    1. Progression Free Survival (PFS) [12 months post last participant enrollment date]

      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.

    Secondary Outcome Measures

    1. Overall Response Rate (ORR) [Up to 60 days post last study treatment]

      Overall response rate (ORR) 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.

    2. Minimum Response (MR) [Up to 60 days post last study treatment]

      Minimum response (MR) or better rate 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.

    3. Time to Next Treatment (TTNT) [Up to 60 days post last study treatment]

      Time to next treatment (TTNT): Median time free of treatment per study arm.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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)

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1H. Lee Moffitt Cancer Center and Research InstituteTampaFloridaUnited States33612

    Sponsors and Collaborators

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

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    H. Lee Moffitt Cancer Center and Research Institute
    ClinicalTrials.gov Identifier:
    NCT03411031
    Other Study ID Numbers:
    • MCC-19197
    • NCI-2018-00891
    First Posted:
    Jan 25, 2018
    Last Update Posted:
    Nov 16, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by H. Lee Moffitt Cancer Center and Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 16, 2021