<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02969837</url>
  </required_header>
  <id_info>
    <org_study_id>IRB16-1138</org_study_id>
    <nct_id>NCT02969837</nct_id>
  </id_info>
  <brief_title>Study of Initial Treatment With Elotuzumab, Carfilzomib, Lenalidomide and Dexamethasone in Multiple Myeloma</brief_title>
  <official_title>Open-label, Single-arm, Phase 2 Study of Initial Treatment With Elotuzumab, Carfilzomib (Kyprolis), Lenalidomide (Revlimid) and Low Dose Dexamethasone (E-KRd) in Newly Diagnosed, Multiple Myeloma Requiring Systemic Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Multiple Myeloma Research Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Chicago</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be a multi-center, open-label, Phase 2 study where newly diagnosed Multiple&#xD;
      Myeloma requiring systemic chemotherapy will be eligible for enrollment. A total of 55&#xD;
      subjects will be enrolled. Time to progression or death will be calculated from the date of&#xD;
      first treatment on protocol until the date of disease progression or death from any cause.&#xD;
      Patients can expect to participate between 12-24 cycles. The primary endpoint will be the&#xD;
      rate of response by next generation gene sequencing at the end of 8 cycles among&#xD;
      non-transplant candidates and transplant candidates who agreed to defer transplant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objective&#xD;
&#xD;
      • The primary efficacy endpoint will be the rate of sCR and/or the rate of negative MRD by&#xD;
      next generation gene sequencing (NGS) by clonoSIGHT (Adaptive Biotechnologies) at the end of&#xD;
      8 cycles among non-transplant candidates and transplant candidates who agreed to defer&#xD;
      transplant&#xD;
&#xD;
      Secondary Objectives&#xD;
&#xD;
        -  To evaluate the safety and tolerability of elotuzumab in combination with KRd, when&#xD;
           administered to subjects with newly diagnosed multiple myeloma.&#xD;
&#xD;
        -  To determine the rate of MRD by next generation gene sequencing (NGS) by clonoSIGHT&#xD;
           (Adaptive Biotechnologies) and by multi-color flow cytometry (MFC) at the end of Cycle&#xD;
           4, 8,and 12 for all subjects, and end of C18 (for subjects who are MRD+ at the end of C8&#xD;
           but MRD- at the end of C12 only), 24 months after C1D1, and yearly after that.&#xD;
&#xD;
        -  To estimate time to event, including duration of response (DOR), progression-free&#xD;
           survival (PFS), time to progression (TTP), and overall survival (OS).&#xD;
&#xD;
      Exploratory Objectives&#xD;
&#xD;
        -  GEP, proteomics, and gene sequencing to evaluate the correlation between treatment&#xD;
           outcome and pre-treatment subject profile.&#xD;
&#xD;
        -  Immunologic correlative studies including FcγRIIIa V genotype.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 10, 2017</start_date>
  <completion_date type="Anticipated">March 2029</completion_date>
  <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>All participants will receive E-KRd regimen (elotuzumab, carfilzomib, lenalidomide, and dexamethasone) for up to 12 Cycles.&#xD;
After Cycle 12, participants that are MRD negative will move to E-Rd (elotuzumab, carfilzomib, lenalidomide, and dexamethasone) maintenance regimen and continue until disease progression. Participants that are MRD positive will continue to receive E-KRd regimen for an additional 6 cycles followed by E-Rd maintenance regimen and continue until disease progression</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of sCR</measure>
    <time_frame>At the end of eight months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of negative MRD</measure>
    <time_frame>At the end of eight months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events of elotuzumab in combination with KRd</measure>
    <time_frame>Through study completion an average of one year, adverse events will be monitored in real time</time_frame>
    <description>Adverse events will be monitored in real time and discussed at a weekly data and safety monitoring conference.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of MRD</measure>
    <time_frame>At the end of four, eight, and twelve months for certain subjects.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Through study completion an average of one year</time_frame>
    <description>These events will be analyzed at differing points of time based on the individual subjects disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>Through study completion an average of one year</time_frame>
    <description>These events will be analyzed at differing points of time based on the individual subjects disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to progression</measure>
    <time_frame>Through study completion an average of one year</time_frame>
    <description>These events will be analyzed at differing points of time based on the individual subjects disease progression.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Through study completion an average of one year</time_frame>
    <description>These events will be analyzed at differing points of time based on the individual subjects disease progression.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Logisitc Regression for analyzing exploratory biomarkers</measure>
    <time_frame>After study completion an average of one year</time_frame>
    <description>Subjects will have the option to participate in additional genetic components of this trial if they provide their consent. Once a subject has completed participation in the trial, if they agree to participate in the optional components their disease will be analyzed in relation to people with similar genetic make up.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>E-KRd regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive elotuzumab, carfilzomib, lenalidomide, and dexamethasone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E-Rd Regimen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive elotuzumab, lenalidomide, and dexamethasone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Elotuzumab</intervention_name>
    <description>Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15</description>
    <arm_group_label>E-KRd regimen</arm_group_label>
    <arm_group_label>E-Rd Regimen</arm_group_label>
    <other_name>Empliciti</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carfilzomib</intervention_name>
    <description>Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond</description>
    <arm_group_label>E-KRd regimen</arm_group_label>
    <other_name>Kryprolis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Lenalidomide</intervention_name>
    <description>Lenalidomide will be given on days 1-21 for all cycles.</description>
    <arm_group_label>E-KRd regimen</arm_group_label>
    <arm_group_label>E-Rd Regimen</arm_group_label>
    <other_name>Revlimid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Dexamethasone will be given as follows:&#xD;
Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22</description>
    <arm_group_label>E-KRd regimen</arm_group_label>
    <arm_group_label>E-Rd Regimen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must meet all of the following inclusion criteria to be eligible to enroll in&#xD;
             this study. No enrollment waivers will be granted.&#xD;
&#xD;
               1. Newly diagnosed, previously untreated myeloma requiring systemic chemotherapy&#xD;
&#xD;
                  a. Prior treatment of hypercalcemia or spinal cord compression or active and/or&#xD;
                  aggressively progressing myeloma with corticosteroids and/or lenalidomide and/or&#xD;
                  bortezomib/PI-based regimens does not disqualify the subject (the corticosteroid&#xD;
                  treatment dose should not exceed the equivalent of 160 mg of dexamethasone in a 4&#xD;
                  week period or not more than 1 cycle of lenalidomide and/or PI-based therapy)&#xD;
&#xD;
               2. Both transplant and non-transplant candidates are eligible.&#xD;
&#xD;
               3. Diagnosis of symptomatic multiple myeloma as per current IMWG uniform criteria&#xD;
                  prior to initial treatment&#xD;
&#xD;
               4. Monoclonal plasma cells in the BM 10% or presence of a biopsy-proven plasmacytoma&#xD;
&#xD;
               5. Measurable disease, prior to initial treatment as indicated by one or more of the&#xD;
                  following:&#xD;
&#xD;
                    1. Serum M-protein ≥ 1 g/dL&#xD;
&#xD;
                    2. Urine M-protein ≥ 200 mg/24 hours&#xD;
&#xD;
                    3. If serum protein electrophoresis is felt to be unreliable for routine&#xD;
                       M-protein measurement, then quantitative immunoglobulin levels are&#xD;
                       acceptable (≥ 1 g/dL)&#xD;
&#xD;
                    4. Involved serum free light chains ≥ 10 mg/dL provided that free light chain&#xD;
                       ratio is abnormal&#xD;
&#xD;
               6. Screening laboratory values must meet the following criteria and should be&#xD;
                  obtained within 21 days prior to enrollment WBC ≥ 2000/µL Platelets ≥ 75 x103/µL&#xD;
                  ANC &gt;1000/µL Hemoglobin &gt; 8.0 g/dL Serum creatinine ≤ 1.5 x ULN or creatinine&#xD;
                  clearance (CrCl) ≥ 50 mL/min&#xD;
&#xD;
                    1. Use the Cockcroft-Gault formula below):&#xD;
&#xD;
                       o Female CrCl = (140 - age in years) x weight in kg x 0.85&#xD;
&#xD;
                         -  72 x serum creatinine in mg/dL&#xD;
&#xD;
                            o Male CrCl = (140 - age in years) x weight in kg x 1.00&#xD;
&#xD;
                         -  72 x serum creatinine in mg/dL&#xD;
&#xD;
                    2. Alternatively to Cockcroft-Gault formula of CrCl, 24hr urine CrCl can be&#xD;
                       used AST/ALT ≤ 3 x ULN Total Bilirubin ≤ 1.5 x ULN (except subjects with&#xD;
                       Gilbert Syndrome, who can have total bilirubin &lt; 3.0 mg/dL) or ≤ 2 x ULN if&#xD;
                       lenalidomide is being prescribed.&#xD;
&#xD;
               7. Males and females ≥ 18 years of age&#xD;
&#xD;
               8. ECOG performance status of 0-1&#xD;
&#xD;
               9. Females of childbearing potential (FCBP) must have 2 negative pregnancy tests&#xD;
                  (sensitivity of at least 50 mIU/mL) prior to initiating lenalidomide. The first&#xD;
                  pregnancy test must be performed within 10-14 days before and the second&#xD;
                  pregnancy test must be performed within 24 hours before lenalidomide is&#xD;
                  prescribed for Cycle 1 (prescriptions must be filled within 7 days).&#xD;
&#xD;
              10. FCBP must agree to use 2 reliable forms of contraception simultaneously or to&#xD;
                  practice complete abstinence from heterosexual intercourse during the following&#xD;
                  time periods related to this study: 1) for at least 28 days before starting&#xD;
                  lenalidomide; 2) while participating in the study; and 3) for at least 28 days&#xD;
                  after discontinuation from the study.&#xD;
&#xD;
              11. Male subjects must agree to use a latex condom during sexual contact with females&#xD;
                  of childbearing potential while participating in the study and for at least 28&#xD;
                  days following discontinuation from the study even if he has undergone a&#xD;
                  successful vasectomy.&#xD;
&#xD;
              12. All study participants in the US must be consented to and registered into the&#xD;
                  mandatory Revlimid REMS program and be willing and able to comply with the&#xD;
                  requirements of Revlimid REMS.&#xD;
&#xD;
              13. Voluntary written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects meeting any of the following exclusion criteria are not eligible to enroll in&#xD;
             this study. No enrollment waivers will be granted.&#xD;
&#xD;
               1. Non-secretory or hyposecretory multiple myeloma, prior to initial treatment&#xD;
                  defined as &lt;1.0 g/dL M-protein in serum, &lt;200 mg/24 hr urine M-protein, and no&#xD;
                  measurable disease as per IMWG by Freelite.&#xD;
&#xD;
               2. POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein,&#xD;
                  and skin changes)&#xD;
&#xD;
               3. Geriatric assessment score of ≥2 as defined by Palumbo et al.&#xD;
&#xD;
               4. Known or suspected Amyloidosis&#xD;
&#xD;
               5. Plasma cell leukemia&#xD;
&#xD;
               6. Within 4 weeks since any plasmapheresis&#xD;
&#xD;
               7. Within 3 weeks of any corticosteroids except per inclusion criteria #2&#xD;
&#xD;
               8. Waldenström's macroglobulinemia or IgM myeloma&#xD;
&#xD;
               9. Participation in an investigational therapeutic study within 3 weeks or within 5&#xD;
                  drug half-lives (t1/2) prior to first dose, whichever time is greater&#xD;
&#xD;
              10. Subjects not able to tolerate elotuzumab, lenalidomide, carfilzomib, or&#xD;
                  dexamethasone&#xD;
&#xD;
              11. Peripheral neuropathy ≥ Grade 2 at screening&#xD;
&#xD;
              12. Prior CVA with persistent neurological deficit&#xD;
&#xD;
              13. Diarrhea &gt; Grade 1 in the absence of antidiarrheals&#xD;
&#xD;
              14. CNS involvement&#xD;
&#xD;
              15. Corrected calcium ≥ 11.5 mg/dL within 2 weeks of randomization&#xD;
&#xD;
              16. Pregnant or lactating females&#xD;
&#xD;
              17. Radiotherapy within 14 days before randomization. Seven days may be considered if&#xD;
                  to single area&#xD;
&#xD;
              18. Major surgery within 3 weeks prior to first dose&#xD;
&#xD;
              19. Subject has clinically significant cardiac disease, including:&#xD;
&#xD;
                    -  myocardial infarction within 1 year before Cycle 1 Day 1, or an unstable or&#xD;
                       uncontrolled disease/condition related to or affecting cardiac function (eg,&#xD;
                       unstable angina, congestive heart failure, New York Heart Association Class&#xD;
                       III-IV&#xD;
&#xD;
                    -  uncontrolled cardiac arrhythmia (NCI CTCAE Version 4 Grade 2:2) or&#xD;
                       clinically significant ECG abnormalities&#xD;
&#xD;
                    -  screening 12-lead ECG showing a baseline QT interval as corrected by&#xD;
                       Fridericia's formula (QTcF) &gt;470 msec&#xD;
&#xD;
              20. Uncontrolled HTN 14 days prior to enrollment&#xD;
&#xD;
              21. Prior or concurrent deep vein thrombosis or pulmonary embolism&#xD;
&#xD;
              22. Rate-corrected QT interval of electrocardiograph (QTc) &gt; 470 msec on a 12-lead&#xD;
                  ECG during screening&#xD;
&#xD;
              23. Uncontrolled hypertension (defined as average systolic blood pressure ≥140 or&#xD;
                  average diastolic blood pressure ≥90, with blood pressure measured ≥3 times in&#xD;
                  the two weeks prior to enrollment ) or diabetes&#xD;
&#xD;
              24. Acute infection requiring systemic antibiotics, antivirals, or antifungals within&#xD;
                  two weeks prior to first dose&#xD;
&#xD;
              25. Active infection&#xD;
&#xD;
              26. Known seropositive for or active viral infection with human immunodeficiency&#xD;
                  virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Subjects who are&#xD;
                  seropositive because of hepatitis B virus vaccine are eligible.&#xD;
&#xD;
              27. Non-hematologic malignancy or non-myeloma hematologic malignancy within the past&#xD;
                  3 years except a) adequately treated basal cell, squamous cell skin cancer,&#xD;
                  thyroid cancer, carcinoma in situ of the cervix, or prostate cancer &lt; Gleason&#xD;
                  Grade 6 with stable prostate specific antigen levels or cancer considered cured&#xD;
                  by surgical resection alone&#xD;
&#xD;
              28. Any clinically significant medical disease or condition that, in the Treating&#xD;
                  Investigator's opinion, may interfere with protocol adherence or a subject's&#xD;
                  ability to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrzej Jakubowiak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chicago</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NorthShore University Health System</name>
      <address>
        <city>Evanston</city>
        <state>Illinois</state>
        <zip>60201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan Comprehensive Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>April 26, 2023</last_update_submitted>
  <last_update_submitted_qc>April 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Elotuzumab</keyword>
  <keyword>Carfilzomib (Kyprolis)</keyword>
  <keyword>Lenalidomide (Revlimid)</keyword>
  <keyword>Dexamethasone (E-KRd)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Lenalidomide</mesh_term>
    <mesh_term>Elotuzumab</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02969837
org study id: IRB16-1138
nct id: NCT02969837
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study will be a multi-center, open-label, Phase 2 study where newly diagnosed Multiple
      Myeloma requiring systemic chemotherapy will be eligible for enrollment. A total of 55
      subjects will be enrolled. Time to progression or death will be calculated from the date of
      first treatment on protocol until the date of disease progression or death from any cause.
      Patients can expect to participate between 12-24 cycles. The primary endpoint will be the
      rate of response by next generation gene sequencing at the end of 8 cycles among
      non-transplant candidates and transplant candidates who agreed to defer transplant.
Primary Objective

      • The primary efficacy endpoint will be the rate of sCR and/or the rate of negative MRD by
      next generation gene sequencing (NGS) by clonoSIGHT (Adaptive Biotechnologies) at the end of
      8 cycles among non-transplant candidates and transplant candidates who agreed to defer
      transplant

      Secondary Objectives

        -  To evaluate the safety and tolerability of elotuzumab in combination with KRd, when
           administered to subjects with newly diagnosed multiple myeloma.

        -  To determine the rate of MRD by next generation gene sequencing (NGS) by clonoSIGHT
           (Adaptive Biotechnologies) and by multi-color flow cytometry (MFC) at the end of Cycle
           4, 8,and 12 for all subjects, and end of C18 (for subjects who are MRD+ at the end of C8
           but MRD- at the end of C12 only), 24 months after C1D1, and yearly after that.

        -  To estimate time to event, including duration of response (DOR), progression-free
           survival (PFS), time to progression (TTP), and overall survival (OS).

      Exploratory Objectives

        -  GEP, proteomics, and gene sequencing to evaluate the correlation between treatment
           outcome and pre-treatment subject profile.

        -  Immunologic correlative studies including FcγRIIIa V genotype.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: All participants will receive E-KRd regimen (elotuzumab, carfilzomib, lenalidomide, and dexamethasone) for up to 12 Cycles.
After Cycle 12, participants that are MRD negative will move to E-Rd (elotuzumab, carfilzomib, lenalidomide, and dexamethasone) maintenance regimen and continue until disease progression. Participants that are MRD positive will continue to receive E-KRd regimen for an additional 6 cycles followed by E-Rd maintenance regimen and continue until disease progression
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of sCR
time frame: At the end of eight months
measure: Rate of negative MRD
time frame: At the end of eight months
measure: Number of participants with adverse events of elotuzumab in combination with KRd
time frame: Through study completion an average of one year, adverse events will be monitored in real time
description: Adverse events will be monitored in real time and discussed at a weekly data and safety monitoring conference.
measure: Rate of MRD
time frame: At the end of four, eight, and twelve months for certain subjects.
measure: Duration of response
time frame: Through study completion an average of one year
description: These events will be analyzed at differing points of time based on the individual subjects disease progression.
measure: Progression free survival
time frame: Through study completion an average of one year
description: These events will be analyzed at differing points of time based on the individual subjects disease progression.
measure: Time to progression
time frame: Through study completion an average of one year
description: These events will be analyzed at differing points of time based on the individual subjects disease progression.
measure: Overall survival
time frame: Through study completion an average of one year
description: These events will be analyzed at differing points of time based on the individual subjects disease progression.
measure: Logisitc Regression for analyzing exploratory biomarkers
time frame: After study completion an average of one year
description: Subjects will have the option to participate in additional genetic components of this trial if they provide their consent. Once a subject has completed participation in the trial, if they agree to participate in the optional components their disease will be analyzed in relation to people with similar genetic make up.
arm group label: E-KRd regimen
arm group type: Experimental
description: Participants will receive elotuzumab, carfilzomib, lenalidomide, and dexamethasone.
arm group label: E-Rd Regimen
arm group type: Experimental
description: Participants will receive elotuzumab, lenalidomide, and dexamethasone.
intervention type: Drug
intervention name: Elotuzumab
description: Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15
arm group label: E-KRd regimen
arm group label: E-Rd Regimen
other name: Empliciti
intervention type: Drug
intervention name: Carfilzomib
description: Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond
arm group label: E-KRd regimen
other name: Kryprolis
intervention type: Drug
intervention name: Lenalidomide
description: Lenalidomide will be given on days 1-21 for all cycles.
arm group label: E-KRd regimen
arm group label: E-Rd Regimen
other name: Revlimid
intervention type: Drug
intervention name: Dexamethasone
description: Dexamethasone will be given as follows:
Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22
arm group label: E-KRd regimen
arm group label: E-Rd Regimen
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrzej Jakubowiak, MD
role: Principal Investigator
affiliation: University of Chicago
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Lenalidomide
mesh term: Elotuzumab