Clinical Trials /

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

NCT03411031

Description:

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.

Related Conditions:
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Elotuzumab Plus Lenalidomide (Elo/Rev) for Serologic Relapse/Progression While on Lenalidomide
  • 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

Clinical Trial IDs

  • ORG STUDY ID: MCC-19197
  • SECONDARY ID: NCI-2018-00891
  • NCT ID: NCT03411031

Conditions

  • Multiple Myeloma

Interventions

DrugSynonymsArms
ElotuzumabEmpliciti™, BMS-901608, HuLuc63A: Elotuzumab + Lenalidomide at 25 mg
LenalidomideREVLIMID®, thalidomide analogueA: Elotuzumab + Lenalidomide at 25 mg
DexamethasoneDecadronA: Elotuzumab + Lenalidomide at 25 mg

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
A: Elotuzumab + Lenalidomide at 25 mgActive ComparatorElotuzumab 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.
  • Elotuzumab
  • Lenalidomide
  • Dexamethasone
B: Elotuzumab + Lenalidomide at 10 mgActive ComparatorElotuzumab 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.
  • Elotuzumab
  • Lenalidomide
  • Dexamethasone

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)
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Progression Free Survival (PFS)
Time Frame:12 months post last participant enrollment date
Safety Issue:
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.

Secondary Outcome Measures

Measure:Overall Response Rate (ORR)
Time Frame:Up to 60 days post last study treatment
Safety Issue:
Description: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.
Measure:Minimum Response (MR)
Time Frame:Up to 60 days post last study treatment
Safety Issue:
Description: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.
Measure:Time to Next Treatment (TTNT)
Time Frame:Up to 60 days post last study treatment
Safety Issue:
Description:Time to next treatment (TTNT): Median time free of treatment per study arm.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

Trial Keywords

  • lenalidomide maintenance
  • hematopoietic cell transplantation
  • serologic relapse

Last Updated

December 30, 2019