<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/NCT03785184</url>
  </required_header>
  <id_info>
    <org_study_id>M16-104</org_study_id>
    <nct_id>NCT03785184</nct_id>
  </id_info>
  <brief_title>A Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy</brief_title>
  <official_title>A Phase 2, Multicenter, Single Arm, Open Label Study of Venetoclax Plus Lenalidomide and Dexamethasone for the Treatment of Newly Diagnosed t(11;14)-Positive Multiple Myeloma in Subjects Who Are Ineligible for High-Dose Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Genentech, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Celgene Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AbbVie</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety and preliminary efficacy of venetoclax when combined with&#xD;
      lenalidomide and dexamethasone for participants with newly diagnosed, active t(11;14)&#xD;
      positive multiple myeloma (MM).&#xD;
&#xD;
      This study will consist of 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Strategic considerations&#xD;
  </why_stopped>
  <start_date type="Anticipated">April 29, 2019</start_date>
  <completion_date type="Actual">August 22, 2019</completion_date>
  <primary_completion_date type="Actual">August 22, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participates Who Achieve CR</measure>
    <time_frame>From baseline up to approximately 24 months</time_frame>
    <description>Complete response (CR) is defined as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and &lt; 5% plasma cells in bone marrow.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent of Participants Who Achieve MRD Negativity</measure>
    <time_frame>From baseline up to approximately 24 months</time_frame>
    <description>Minimal residual disease (MRD) negative after treatment is described as less than one myeloma cell per 100,000 bone marrow cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Participants Who Achieve VGPR or Better</measure>
    <time_frame>From baseline up to approximately 24 months</time_frame>
    <description>Very Good Partial Response (VGPR) per international myeloma working group (IMWG) criteria is defined as serum or urine myeloma protein (m-protein) detectable by immunofixation but not on electrophoresis, or greater than or equal to 90% reduction in serum m-protein and urine m-protein less than 100 mg/24 hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>From baseline up to approximately 24 months</time_frame>
    <description>ORR is described as the percentage of participants who experience partial response (PR) or better; PR per IMWG is described as follows:&#xD;
≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M protein by ≥ 90% or to &lt; 200 mg/24 h&#xD;
If the serum and urine M-protein are not measurable, a decrease ≥ 50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria&#xD;
If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, ≥ 50% reduction in bone marrow plasma cells is required in place of M-protein, provided baseline percentage was ≥ 30%&#xD;
In addition, if present at baseline, ≥ 50% reduction in size of soft tissue plasmacytomas is also required</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response (TTR)</measure>
    <time_frame>From baseline up to approximately 24 months</time_frame>
    <description>Time to response is defined as the time from randomization to the first response (CR, stringent complete response [sCR], VGPR, PR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>Approximately 7 years</time_frame>
    <description>DOR is defined as the time from first observation of PR to the time of disease progression, with deaths from causes other than progression censored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS)</measure>
    <time_frame>Approximately 7 years</time_frame>
    <description>PFS is defined as time from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Minimal Residual Disease (MRD) Negativity Rate at 12 Months</measure>
    <time_frame>Approximately 12 months after initial dose of study drug</time_frame>
    <description>Percent of participants meeting the MRD Negative criteria at 12 months after initial dose; MRD Negative defined as less than one myeloma cell per 100,000 bone marrow cells.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Disease Progression (TTP)</measure>
    <time_frame>Approximately 7 years</time_frame>
    <description>TTP is defined as the time from start of treatment to disease progression, with deaths from causes other than progression censored.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Next Treatment (TTNT)</measure>
    <time_frame>Approximately 7 years</time_frame>
    <description>The time to next treatment is defined as the time between the date of the first study drug intake and the date of the first next treatment intake after study drug discontinuation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) Rate</measure>
    <time_frame>Approximately 7 years</time_frame>
    <description>OS was defined as the time from the date the participant was randomized to the date of death.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Venetoclax + Lenalidomide + Dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Venetoclax up to 800 mg orally every day (QD) QD on Days 1 - 28 plus lenalidomide up to 25 mg orally QD on Days 1 - 21 (28 day cycle) plus dexamethasone up to 40 mg orally once weekly (QW).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>venetoclax</intervention_name>
    <description>tablet; oral</description>
    <arm_group_label>Venetoclax + Lenalidomide + Dexamethasone</arm_group_label>
    <other_name>ABT-199</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lenalidomide</intervention_name>
    <description>capsule; oral</description>
    <arm_group_label>Venetoclax + Lenalidomide + Dexamethasone</arm_group_label>
    <other_name>Revlimid</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dexamethasone</intervention_name>
    <description>tablet; oral</description>
    <arm_group_label>Venetoclax + Lenalidomide + Dexamethasone</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Must have documented, confirmed active multiple myeloma (MM) with greater than or&#xD;
             equal to 10% clonal bone marrow plasma cells or biopsy-proven bone or extramedullary&#xD;
             plasmacytoma and any one or more of the following myeloma-defining events:&#xD;
&#xD;
               -  Evidence of end organ damage attributed to the underlying plasma cell&#xD;
                  proliferative disorder and satisfying at least one of the protocol specified&#xD;
                  laboratory criteria for calcium elevation, renal failure, anemia, or lytic bone&#xD;
                  lesions; OR&#xD;
&#xD;
               -  One or more of the biomarkers of malignancy as described in the protocol.&#xD;
&#xD;
          -  Must have MM positive for the t(11;14) translocation, as determined by methods&#xD;
             described in the protocol.&#xD;
&#xD;
          -  Must have measurable disease defined by at least one of the following criteria:&#xD;
&#xD;
               -  Serum M-protein ≥ 1.0 g/dL (immunoglobulin [Ig]G myeloma) or greater than or&#xD;
                  equal to 0.5 g/dL (IgA, IgM, IgD, or IgE myeloma);&#xD;
&#xD;
               -  Urine M-protein greater than or equal to 200 mg/24 hours;&#xD;
&#xD;
               -  Serum free light chain (FLC) greater than or equal to 10 mg/dL (100 mg/L)&#xD;
                  provided serum FLC ratio is abnormal.&#xD;
&#xD;
          -  Newly diagnosed and not considered a candidate for high-dose therapy and hematopoietic&#xD;
             stem cell transplantation (HSCT)&#xD;
&#xD;
          -  Must have Eastern Cooperative Oncology Group performance status less than or equal to&#xD;
             2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has a co-existing condition as specified in the protocol.&#xD;
&#xD;
          -  Has history of other active malignancies, including myelodysplastic syndromes (MDS)&#xD;
             within the past 3 years with specific exceptions detailed in the protocol.&#xD;
&#xD;
          -  Has been treated with or received any of the following:&#xD;
&#xD;
               -  Prior or current systemic therapy or hematopoietic stem cell transplantation&#xD;
                  (HSCT) for MM (a short course of treatment with corticosteroids equivalent to&#xD;
                  dexamethasone 40 mg/day for a maximum of 4 days is allowed before treatment); use&#xD;
                  of systemic strong or moderate inhibitor or inducer of cytochrome P450(CYP)3A&#xD;
                  within 7 days before the first dose of study drug.&#xD;
&#xD;
               -  Radiation therapy within 2 weeks of dosing&#xD;
&#xD;
               -  Plasmapheresis within 4 weeks of dosing&#xD;
&#xD;
               -  Immunization with live vaccine within 8 weeks of dosing&#xD;
&#xD;
          -  Has a contraindication or inability to comply with antithrombotic prophylaxis.&#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>AbbVie Inc.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope /ID# 212211</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marin Cancer Care /ID# 208476</name>
      <address>
        <city>Greenbrae</city>
        <state>California</state>
        <zip>94904</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California, Los Angeles /ID# 208516</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Karmanos Cancer Institute /ID# 208805</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital /ID# 208481</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Hospital /ID# 208306</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Ctr /ID# 208121</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital /ID# 210267</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flinders Centre for Innovation /ID# 210697</name>
      <address>
        <city>Bedford Park</city>
        <state>South Australia</state>
        <zip>5042</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincents Hosp Melbourne /ID# 210266</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Austin Hospital /ID# 210268</name>
      <address>
        <city>Heidelberg</city>
        <state>Victoria</state>
        <zip>3084</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre /ID# 210269</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre /ID# 208549</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centr /ID# 208923</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopital Maisonneuver-Rosemont /ID# 208550</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 2M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill Univ HC /ID# 208486</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3G 1A4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitar de Navarra - Pamplona /ID# 209883</name>
      <address>
        <city>Pamplona</city>
        <state>Navarra, Comunidad</state>
        <zip>31008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona /ID# 209888</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hspital Universitario Gregorio Maranon /ID# 209926</name>
      <address>
        <city>Madrid</city>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinica Universitar de Navarra - Madrid /ID# 210131</name>
      <address>
        <city>Madrid</city>
        <zip>28021</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hosp Univ 12 de Octubre /ID# 209887</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Univ Dr. Peset /ID# 209884</name>
      <address>
        <city>Valencia</city>
        <zip>46017</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.rxabbvie.com</url>
    <description>This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.</description>
  </link>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>August 23, 2019</last_update_submitted>
  <last_update_submitted_qc>August 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Cancer</keyword>
  <keyword>t(11;14)-Positive Multiple Myeloma</keyword>
  <keyword>Venetoclax</keyword>
  <keyword>Lenalidomide</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>Venetoclax</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.</ipd_time_frame>
    <ipd_access_criteria>Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.</ipd_access_criteria>
    <ipd_url>https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html</ipd_url>
  </patient_data>
  <!-- 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/NCT03785184
org study id: M16-104
nct id: NCT03785184
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study will evaluate the safety and preliminary efficacy of venetoclax when combined with
      lenalidomide and dexamethasone for participants with newly diagnosed, active t(11;14)
      positive multiple myeloma (MM).

      This study will consist of 2 parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Participates Who Achieve CR
time frame: From baseline up to approximately 24 months
description: Complete response (CR) is defined as negative immunofixation of serum and urine, and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow.
measure: Percent of Participants Who Achieve MRD Negativity
time frame: From baseline up to approximately 24 months
description: Minimal residual disease (MRD) negative after treatment is described as less than one myeloma cell per 100,000 bone marrow cells.
measure: Percent of Participants Who Achieve VGPR or Better
time frame: From baseline up to approximately 24 months
description: Very Good Partial Response (VGPR) per international myeloma working group (IMWG) criteria is defined as serum or urine myeloma protein (m-protein) detectable by immunofixation but not on electrophoresis, or greater than or equal to 90% reduction in serum m-protein and urine m-protein less than 100 mg/24 hours.
measure: Overall Response Rate (ORR)
time frame: From baseline up to approximately 24 months
description: ORR is described as the percentage of participants who experience partial response (PR) or better; PR per IMWG is described as follows:
≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M protein by ≥ 90% or to < 200 mg/24 h
If the serum and urine M-protein are not measurable, a decrease ≥ 50% in the difference between involved and uninvolved free light chain (FLC) levels is required in place of the M-protein criteria
If serum and urine M-protein are not measurable, and serum free light assay is also not measurable, ≥ 50% reduction in bone marrow plasma cells is required in place of M-protein, provided baseline percentage was ≥ 30%
In addition, if present at baseline, ≥ 50% reduction in size of soft tissue plasmacytomas is also required
measure: Time to Response (TTR)
time frame: From baseline up to approximately 24 months
description: Time to response is defined as the time from randomization to the first response (CR, stringent complete response [sCR], VGPR, PR).
measure: Duration of response (DOR)
time frame: Approximately 7 years
description: DOR is defined as the time from first observation of PR to the time of disease progression, with deaths from causes other than progression censored.
measure: Progression-free Survival (PFS)
time frame: Approximately 7 years
description: PFS is defined as time from start of the treatment to disease progression or death (regardless of cause of death), whichever comes first.
measure: Minimal Residual Disease (MRD) Negativity Rate at 12 Months
time frame: Approximately 12 months after initial dose of study drug
description: Percent of participants meeting the MRD Negative criteria at 12 months after initial dose; MRD Negative defined as less than one myeloma cell per 100,000 bone marrow cells.
measure: Time to Disease Progression (TTP)
time frame: Approximately 7 years
description: TTP is defined as the time from start of treatment to disease progression, with deaths from causes other than progression censored.
measure: Time to Next Treatment (TTNT)
time frame: Approximately 7 years
description: The time to next treatment is defined as the time between the date of the first study drug intake and the date of the first next treatment intake after study drug discontinuation.
measure: Overall Survival (OS) Rate
time frame: Approximately 7 years
description: OS was defined as the time from the date the participant was randomized to the date of death.
arm group label: Venetoclax + Lenalidomide + Dexamethasone
arm group type: Experimental
description: Venetoclax up to 800 mg orally every day (QD) QD on Days 1 - 28 plus lenalidomide up to 25 mg orally QD on Days 1 - 21 (28 day cycle) plus dexamethasone up to 40 mg orally once weekly (QW).
intervention type: Drug
intervention name: venetoclax
description: tablet; oral
arm group label: Venetoclax + Lenalidomide + Dexamethasone
other name: ABT-199
intervention type: Drug
intervention name: lenalidomide
description: capsule; oral
arm group label: Venetoclax + Lenalidomide + Dexamethasone
other name: Revlimid
intervention type: Drug
intervention name: dexamethasone
description: tablet; oral
arm group label: Venetoclax + Lenalidomide + Dexamethasone
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: AbbVie Inc.
role: Study Director
affiliation: AbbVie
facility: 
facility: 
facility: 
facility: 
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country: Australia
country: Canada
country: Spain
country: United States
url: http://www.rxabbvie.com
description: This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Dexamethasone
mesh term: Lenalidomide
mesh term: Venetoclax
sharing ipd: Yes
ipd description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
ipd access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
ipd url: https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html