<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/NCT04478123</url>
  </required_header>
  <id_info>
    <org_study_id>20-180</org_study_id>
    <nct_id>NCT04478123</nct_id>
  </id_info>
  <brief_title>Using Romiplostim to Treat Low Platelet Counts Following Chemotherapy and Autologous Hematopoietic Cell Transplantation in People With Blood Cancer</brief_title>
  <official_title>An Open-Label, Pilot Study of Romiplostim for Conditioning Regimen-Related Thrombocytopenia After High-Dose Therapy and Autologous Hematopoietic Cell Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to see if the study drug, romiplostim, helps low platelet count&#xD;
      caused by the standard blood cancer treatment of chemotherapy and autologous hematopoietic&#xD;
      cell transplantation. This study will also look at whether romiplostim can decrease the&#xD;
      number of times the participant needs to return to the clinic for platelet transfusions to&#xD;
      treat their low platelet count. In addition, the researchers will determine how safe it is to&#xD;
      give romiplostim to people with blood cancer who have received treatment with chemotherapy&#xD;
      and autologous hematopoietic cell transplantation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Actual">June 8, 2023</completion_date>
  <primary_completion_date type="Actual">June 8, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A single-center, open-label, pilot study of romiplostim for patients undergoing HDT-AHCT.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>number of days post HDT-AHCT requiring transfusions or grade 4 CTCAE thrombocytopenia</measure>
    <time_frame>up to 42 days</time_frame>
    <description>Common Terminology Criteria for Adverse Events (CTCAE) Version 5.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of platelet transfusions issued during the AHCT admission</measure>
    <time_frame>up to 100 days from AHCT</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Multiple Myeloma</condition>
  <condition>Hodgkin Lymphoma</condition>
  <condition>Non-Hodgkin Lymphoma</condition>
  <condition>HDT-AHCT</condition>
  <arm_group>
    <arm_group_label>romiplostim</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be enrolled prior to admission for High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT), and they will undergo their planned HDT-AHCT for their respective hematologic malignancy as per institutional standards.&#xD;
Regardless of the conditioning regimen received, all patients will receive romiplostim 3.0 mcg/kg SC on Day +1 and romiplostim 2.0 mcg/kg SC on Day +8 after HDT-AHCT. Beyond Day +8, patients will be treated until platelet count is &gt;50,000/mcL, without any platelet transfusions in the prior 48 hours. All doses after the second romiplostim dose will be titrated as per Table 3, based on weekly CBC/platelet counts. No patient will receive more than six doses of romiplostim, even if platelets have not corrected by Day +42.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Romiplostim</intervention_name>
    <description>Romiplostim 3.0 mcg/kg SC on Day +1 and Romiplostim 2.0 mcg/kg SC on Day +8 after HDT-AHCT. Beyond Day +8, patients will be treated weekly until platelet count is &gt;50,000/mcL, without any platelet transfusions in the prior 48 hours. All doses after the second Romiplostim dose will be titrated as per Table 3, based on weekly CBC/platelet counts. Patients will receive a maximum of six weekly doses of romiplostim.</description>
    <arm_group_label>romiplostim</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients ≥ 18 years old diagnosed with multiple myeloma (MM), any subtype of&#xD;
             Hodgkin lymphoma (HL), or any subtype of non-Hodgkin lymphoma (NHL)&#xD;
&#xD;
               -  For MM, the conditioning regimen used will be high-dose melphalan.°For HL and&#xD;
                  NHL, the conditioning will be one of the following high-dose regimens: BEAM, CBV,&#xD;
                  or TBC.&#xD;
&#xD;
               -  Other conditioning regimens not listed above, or variations of the above&#xD;
                  conditioning regimens, may be allowed at the discretion of the principal&#xD;
                  investigator if the regimen is considered myeloablative.&#xD;
&#xD;
          -  Adequate organ function is required, defined as follows:&#xD;
&#xD;
               -  Serum bilirubin ≤ 2 mg/dL, unless benign congenital hyperbilirubinemia.&#xD;
&#xD;
               -  AST, ALT, and alkaline phosphatase &lt; 3 times the upper limit of normal.&#xD;
&#xD;
               -  Creatinine clearance ≥ 40 ml/min (calculated by Cockcroft Gault)&#xD;
&#xD;
               -  LVEF ≥ 45% by MUGA or resting echocardiogram&#xD;
&#xD;
               -  Pulmonary function (FEV1 and corrected DLCO) ≥ 45% predicted.&#xD;
&#xD;
               -  Adequate performance status ECOG ≤ 2.&#xD;
&#xD;
          -  Ability to provide written informed consent.&#xD;
&#xD;
          -  Patients undergoing HDT-AHCT.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a previous diagnosis of a myeloid malignancy.&#xD;
&#xD;
          -  Patients for whom the treating oncologist will be using a non-standard platelet&#xD;
             transfusion threshold during the AHCT.&#xD;
&#xD;
          -  Patients with a history of a prior symptomatic or incidental venous thromboembolic&#xD;
             event (such as DVT or pulmonary embolism) within the prior 6 months are eligible if&#xD;
             they are on and tolerating anti-coagulation, or greater than 6 months ago are eligible&#xD;
             if they completed or are on and tolerating anti-coagulation.&#xD;
&#xD;
             °A venous thrombotic event associated with a central venous catheter will not make the&#xD;
             patient ineligible.&#xD;
&#xD;
          -  Patients with a history of symptomatic arterial thrombotic events such as myocardial&#xD;
             infarction, ischemic cerebral vascular accident or transient ischemic attack in the&#xD;
             past 6 months are ineligible.&#xD;
&#xD;
          -  Patients who had been diagnosed with Immune Thrombocytopenic Purpura (ITP) at any time&#xD;
             prior to the AHCT are ineligible.&#xD;
&#xD;
          -  Patients with a serious concomitant medical condition that could interfere with the&#xD;
             conduct of the clinical trial, such as unstable angina, renal failure requiring&#xD;
             hemodialysis, or active infection requiring IV antibiotics.&#xD;
&#xD;
          -  Previous use of romiplostim, PEGylated recombinant human megakaryocyte growth and&#xD;
             development factor, eltrombopag, recombinant human TPO, any other TPO receptor&#xD;
             agonist, or any investigational platelet producing agent.&#xD;
&#xD;
          -  Females who are pregnant or breastfeeding or planning to become pregnant or breastfeed&#xD;
             during treatment and for an additional 30 days after treatment discontinuation or&#xD;
             longer if required by prescribing information for chemotherapy received during the&#xD;
             study.&#xD;
&#xD;
          -  Patients unwilling to use highly effective contraception during the study period and&#xD;
             for the duration required by prescribing information for chemotherapy(ies)&#xD;
             administered during the study.&#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>Michael Scordo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Monmouth (Limited Protocol Activities)</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Bergen (Limited Protocol Activities)</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Commack (Limited Protocol Activities)</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Westchester (Limited Protocol Activities)</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center (All Protocol Activities)</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Nassau (Limited Protocol Activities)</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>June 9, 2023</last_update_submitted>
  <last_update_submitted_qc>June 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>High-Dose Therapy</keyword>
  <keyword>Autologous Hematopoietic Cell Transplantation</keyword>
  <keyword>Romiplostim</keyword>
  <keyword>Thrombocytopenia</keyword>
  <keyword>20-180</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphoma</mesh_term>
    <mesh_term>Multiple Myeloma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.</ipd_description>
  </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/NCT04478123
org study id: 20-180
nct id: NCT04478123
lead sponsor: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to see if the study drug, romiplostim, helps low platelet count
      caused by the standard blood cancer treatment of chemotherapy and autologous hematopoietic
      cell transplantation. This study will also look at whether romiplostim can decrease the
      number of times the participant needs to return to the clinic for platelet transfusions to
      treat their low platelet count. In addition, the researchers will determine how safe it is to
      give romiplostim to people with blood cancer who have received treatment with chemotherapy
      and autologous hematopoietic cell transplantation.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A single-center, open-label, pilot study of romiplostim for patients undergoing HDT-AHCT.
primary purpose: Treatment
masking: None (Open Label)
measure: number of days post HDT-AHCT requiring transfusions or grade 4 CTCAE thrombocytopenia
time frame: up to 42 days
description: Common Terminology Criteria for Adverse Events (CTCAE) Version 5.
measure: number of platelet transfusions issued during the AHCT admission
time frame: up to 100 days from AHCT
arm group label: romiplostim
arm group type: Experimental
description: Patients will be enrolled prior to admission for High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (HDT-AHCT), and they will undergo their planned HDT-AHCT for their respective hematologic malignancy as per institutional standards.
Regardless of the conditioning regimen received, all patients will receive romiplostim 3.0 mcg/kg SC on Day +1 and romiplostim 2.0 mcg/kg SC on Day +8 after HDT-AHCT. Beyond Day +8, patients will be treated until platelet count is >50,000/mcL, without any platelet transfusions in the prior 48 hours. All doses after the second romiplostim dose will be titrated as per Table 3, based on weekly CBC/platelet counts. No patient will receive more than six doses of romiplostim, even if platelets have not corrected by Day +42.
intervention type: Drug
intervention name: Romiplostim
description: Romiplostim 3.0 mcg/kg SC on Day +1 and Romiplostim 2.0 mcg/kg SC on Day +8 after HDT-AHCT. Beyond Day +8, patients will be treated weekly until platelet count is >50,000/mcL, without any platelet transfusions in the prior 48 hours. All doses after the second Romiplostim dose will be titrated as per Table 3, based on weekly CBC/platelet counts. Patients will receive a maximum of six weekly doses of romiplostim.
arm group label: romiplostim
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael Scordo, MD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Lymphoma
mesh term: Multiple Myeloma
sharing ipd: Yes
ipd description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.