Elotuzumab, Lenalidomide and Dexamethasone (ERd) in the Induction, Consolidation and Maintenance Treatment of Transplant-Eligible, Newly Diagnosed Multiple Myeloma Patients
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|ClinicalTrials.gov Identifier: NCT02843074|
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : May 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: elotuzumab Drug: Lenalidomide Drug: Dexamethasone Procedure: autologous stem cell transplantation||Phase 2|
The primary purpose of this study is to evaluate the feasibility of using the combination of elotuzumab, lenalidomide, and dexamethasone (ERd) as induction therapy and the ability of the combination to facilitate the start of autologous stem cell transplantation (ASCT) in transplant-eligible patients newly diagnosed with multiple myeloma. In addition to induction, the efficacy, safety, and tolerability of ERd as consolidation and maintenance therapy in these patients will be observed.
Eligible patients will undergo four 28-day cycles of an induction regimen of elotuzumab, lenalidomide, and dexamethasone. Following completion of 4 cycles of induction therapy, all patients will undergo standard mobilization, collection of stem cells, and then ASCT using a melphalan conditioning regimen as per institutional guidelines.
Toxicity evaluation will be interrupted during the stem cell procedure and will resume with the onset of consolidation. Adverse events will be collected, however, from the end of induction up to mobilization.
Consolidation therapy will begin 70 to 120 days following ASCT and will consist of four 28-day cycles of elotuzumab, lenalidomide, and dexamethasone. All patients that do not experience progressive disease will begin maintenance therapy of elotuzumab, lenalidomide, and dexamethasone. The duration of maintenance will be 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||53 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study to Assess the Feasibility and Tolerance of the Combination of Elotuzumab, Lenalidomide and Dexamethasone (ERd) in the Induction, Consolidation and Maintenance Treatment of Transplant-Eligible Patients Newly Diagnosed With Multiple Myeloma|
|Actual Study Start Date :||September 21, 2016|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||March 2022|
Experimental: ERd Therapy
Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22.
Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22.
Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22.
After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1.
Given intravenously (IV)
Other Name: Empliciti
Given by IV
Other Name: Revlimid
Given orally (PO) or by IV
Other Name: Decadron
Procedure: autologous stem cell transplantation
Other Name: ASCT
- Induction Feasibility Rate (IFR) [ Time Frame: weekly for 16 weeks ]Defined as the percentage of patients who successfully complete four 28-day cycles of induction therapy with elotuzumab, lenalidomide and dexamethasone (ERd) and are able to start autologous stem cell transplantation (ASCT).
- Complete Response Rate (CRR) [ Time Frame: every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years ]Defined as the percentage of patients who achieve a complete response (CR) or near complete response (nCR) to treatment at each stage of the study (induction, ASCT, consolidation, end of study) per International Myeloma Working Group (IMWG) and European Group for Blood and Marrow Transplantation (EBMT) criteria.
- Overall Response Rate (ORR) [ Time Frame: every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years ]Defined as the percentage of patients who achieve at least a partial response (PR) to treatment at each stage of the study (induction, ASCT, consolidation, end of study) per IMWG and EBMT criteria
- Progression-free survival (PFS) [ Time Frame: every 4 weeks until end of treatment visit, and every 3 months thereafter up to 3 years ]Defined as the time from start of induction treatment to documented progressive disease (PD) or death from any cause up to 3 years post first study treatment
- Overall survival (OS) [ Time Frame: every 4 weeks until end of treatment visit, and up to 3 years thereafter ]Defined as the time from start of induction treatment to 3 years post first study treatment or death from any cause, whichever comes first
- The number of treatment-emergent adverse events, serious adverse events, deaths as a measure of safety [ Time Frame: weekly for 8 weeks, then every 2 weeks till start of mobilization and 70-120 days post-ASCT ]Safety data and abnormal lab values will be collected and assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE V4.03) and abnormal vital signs.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02843074
|Contact: Sarah Cannon Development Innovations||844-710-6157||CANN.InnovationsMedical@sarahcannon.com|
|United States, Colorado|
|Colorado Blood Cancer Institute||Recruiting|
|Denver, Colorado, United States, 80218|
|United States, Maryland|
|Center for Cancer and Blood Disorders||Recruiting|
|Bethesda, Maryland, United States, 20817|
|United States, Missouri|
|HCA Midwest Health/Research Medical Center||Recruiting|
|Kansas City, Missouri, United States, 64132|
|United States, Nebraska|
|Nebraska Methodist Hospital||Recruiting|
|Omaha, Nebraska, United States, 68114|
|United States, Tennessee|
|Chattanooga, Tennessee, United States, 37404|
|Nashville, Tennessee, United States, 37203|
|Contact: Jesus Berdeja, MD|
|Study Chair:||Jesus Berdeja, MD||SCRI Development Innovations, LLC|