xml: <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/NCT05970198</url>
    </required_header>
    <id_info>
      <org_study_id>08</org_study_id>
      <nct_id>NCT05970198</nct_id>
    </id_info>
    <brief_title>Helical Tomotherapy in Multiple Myeloma</brief_title>
    <official_title>A Prospective Randomized Controlled Study of Helical Tomotherapy for Pre-transplantation Pretreatment of Autologous Hematopoietic Stem Cells in Multiple Myeloma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fuling Zhou</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Zhongnan Hospital</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</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>
        To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan&#xD;
        (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a single-center, prospective clinical study targeting myeloma patients&#xD;
        requiring transplantation, and investigating the efficacy and safety of TBI combined with Mel&#xD;
        regimen for transplant pretreatment. Subjects who meet the enrollment criteria were screened&#xD;
        to enter the study and receive the corresponding regimen treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 14, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Complete response rate and above 100 days after transplantation (≥ CR rate)</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>Complete response rate and above 100 days after transplantation (≥ CR rate)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>1-year Progression-free Survival rate</measure>
      <time_frame>1 year</time_frame>
      <description>1-year Progression-free Survival rate</description>
    </secondary_outcome>
    <other_outcome>
      <measure>1-year Overall Survival rate</measure>
      <time_frame>1 year</time_frame>
      <description>1-year Overall Survival rate</description>
    </other_outcome>
    <other_outcome>
      <measure>Platelet implantation time</measure>
      <time_frame>3 months</time_frame>
      <description>Platelet implantation time</description>
    </other_outcome>
    <other_outcome>
      <measure>Neutrophil implantation time</measure>
      <time_frame>3 months</time_frame>
      <description>Neutrophil implantation time</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">58</enrollment>
    <condition>Multiple Myeloma</condition>
    <arm_group>
      <arm_group_label>Autologous hematopoietic stem cell transplantation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Porting method melphalan: recommended dose of 70 mg/m2/day with 2 consecutive days (days -2 and -1) intravenous (IV) for more than 30 minutes each prior to autologous hematopoietic stem cell transplantation (ASCT, day 0).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Radiotherapy combined with autologous hematopoietic stem cell transplantation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>TMI radiation dose On the 5th day (-5 days) before transplantation, an irradiation dose of 8 Gy is given.&#xD;
  TMI uses a 6-18MV linear accelerator, the patient lies on his side in a single irradiation field, covered with a 1 cm thick plexiglass frame, and the radioactive source is 4 meters away from the body surface of the human side. The anterior and anterior positions were alternately irradiated, and the horizontal beam was irradiated in the opposite direction, and the actual irradiation dose was detected by the thermo-optical element of the 2570 roentgen dosimeter scale, and the irradiation dose of all parts of the body was adjusted to make the abdominal irradiation dose difference within 10%, the total dose was 8Gy, divided into 2 times a day, with an interval of 5 hours, and the dose rate was 4.99-6.96cGy/min.Porting method melphalan.</description>
    </arm_group>
    <intervention>
      <intervention_type>Radiation</intervention_type>
      <intervention_name>Total Marrow irradiation，TMI</intervention_name>
      <description>TMI radiation dose On the 5th day (-5 days) before transplantation, an irradiation dose of 8 Gy is given.&#xD;
  TMI uses a 6-18MV linear accelerator, the patient lies on his side in a single irradiation field, covered with a 1 cm thick plexiglass frame, and the radioactive source is 4 meters away from the body surface of the human side. The anterior and anterior positions were alternately irradiated, and the horizontal beam was irradiated in the opposite direction, and the actual irradiation dose was detected by the thermo-optical element of the 2570 roentgen dosimeter scale, and the irradiation dose of all parts of the body was adjusted to make the abdominal irradiation dose difference within 10%, the total dose was 8Gy, divided into 2 times a day, with an interval of 5 hours, and the dose rate was 4.99-6.96cGy/min.</description>
      <arm_group_label>Radiotherapy combined with autologous hematopoietic stem cell transplantation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Autologous hematopoietic stem cell transplantation</intervention_name>
      <description>Autologous hematopoietic stem cell transplantation;Porting method melphalan</description>
      <arm_group_label>Autologous hematopoietic stem cell transplantation</arm_group_label>
      <arm_group_label>Radiotherapy combined with autologous hematopoietic stem cell transplantation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Multiple myeloma patients receiving induction therapy and stem cell mobilization&#xD;
               preparation for autologous transplantation;&#xD;
  &#xD;
            2. Should agree to comply with all contraceptive requirements; 3, ECOG≤2;&#xD;
  &#xD;
          4. Total bilirubin, ALT and AST &lt;2×UNL (upper limit of normal), BUN &lt; 30 mg/dL; 5. At least&#xD;
          2 x 10^6 CD34+ cells /kg were collected; 6.absolute neutrophil count &gt;1000/uL and a&#xD;
          platelet count of &gt;100,000/uL; 7. The expected survival time is more than 3 months; 8.&#xD;
          Written informed consent was obtained from the patients or their immediate family members.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Any of the following was an exclusion criterion:&#xD;
  &#xD;
            1. According to the investigator's judgment, patients who cannot tolerate melphalan and&#xD;
               radiotherapy;&#xD;
  &#xD;
            2. Patients with known active hepatitis B virus (HBV) or hepatitis C virus (HCV), or&#xD;
               seropositive for human immunodeficiency virus (HIV);&#xD;
  &#xD;
            3. patients with uncontrolled or severe cardiovascular disease&#xD;
  &#xD;
            4. According to the protocol or the investigator's judgment, the patient has a serious&#xD;
               physical or mental illness&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fuling Zhou</last_name>
      <role>Study Director</role>
      <affiliation>Wuhan University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fuling Zhou</last_name>
      <phone>+86-02767813137</phone>
      <email>zhoufuling@whu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Zhongnan Hospital of Wuhan University</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430071</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Zhou Fuling, director</last_name>
        <phone>+86-02767813137</phone>
        <email>zhoufuling@163.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Zhongnan Hospital</investigator_affiliation>
      <investigator_full_name>Fuling Zhou</investigator_full_name>
      <investigator_title>Chief physician</investigator_title>
    </responsible_party>
    <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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05970198
  org study id: 08
  nct id: NCT05970198
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  To explore the safety and efficacy of systemic radiotherapy (TBI) combined with melphalan
        (Mel) for pretreatment of autologous hematopoietic stem cells in multiple myeloma.
  This study is a single-center, prospective clinical study targeting myeloma patients
        requiring transplantation, and investigating the efficacy and safety of TBI combined with Mel
        regimen for transplant pretreatment. Subjects who meet the enrollment criteria were screened
        to enter the study and receive the corresponding regimen treatment.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Complete response rate and above 100 days after transplantation (≥ CR rate)
  time frame: through study completion, an average of 1 year
  description: Complete response rate and above 100 days after transplantation (≥ CR rate)
  measure: 1-year Progression-free Survival rate
  time frame: 1 year
  description: 1-year Progression-free Survival rate
  measure: 1-year Overall Survival rate
  time frame: 1 year
  description: 1-year Overall Survival rate
  measure: Platelet implantation time
  time frame: 3 months
  description: Platelet implantation time
  measure: Neutrophil implantation time
  time frame: 3 months
  description: Neutrophil implantation time
  arm group label: Autologous hematopoietic stem cell transplantation
  arm group type: Active Comparator
  description: Porting method melphalan: recommended dose of 70 mg/m2/day with 2 consecutive days (days -2 and -1) intravenous (IV) for more than 30 minutes each prior to autologous hematopoietic stem cell transplantation (ASCT, day 0).
  arm group label: Radiotherapy combined with autologous hematopoietic stem cell transplantation
  arm group type: Experimental
  description: TMI radiation dose On the 5th day (-5 days) before transplantation, an irradiation dose of 8 Gy is given.
  TMI uses a 6-18MV linear accelerator, the patient lies on his side in a single irradiation field, covered with a 1 cm thick plexiglass frame, and the radioactive source is 4 meters away from the body surface of the human side. The anterior and anterior positions were alternately irradiated, and the horizontal beam was irradiated in the opposite direction, and the actual irradiation dose was detected by the thermo-optical element of the 2570 roentgen dosimeter scale, and the irradiation dose of all parts of the body was adjusted to make the abdominal irradiation dose difference within 10%, the total dose was 8Gy, divided into 2 times a day, with an interval of 5 hours, and the dose rate was 4.99-6.96cGy/min.Porting method melphalan.
  intervention type: Radiation
  intervention name: Total Marrow irradiation，TMI
  description: TMI radiation dose On the 5th day (-5 days) before transplantation, an irradiation dose of 8 Gy is given.
  TMI uses a 6-18MV linear accelerator, the patient lies on his side in a single irradiation field, covered with a 1 cm thick plexiglass frame, and the radioactive source is 4 meters away from the body surface of the human side. The anterior and anterior positions were alternately irradiated, and the horizontal beam was irradiated in the opposite direction, and the actual irradiation dose was detected by the thermo-optical element of the 2570 roentgen dosimeter scale, and the irradiation dose of all parts of the body was adjusted to make the abdominal irradiation dose difference within 10%, the total dose was 8Gy, divided into 2 times a day, with an interval of 5 hours, and the dose rate was 4.99-6.96cGy/min.
  arm group label: Radiotherapy combined with autologous hematopoietic stem cell transplantation
  intervention type: Procedure
  intervention name: Autologous hematopoietic stem cell transplantation
  description: Autologous hematopoietic stem cell transplantation;Porting method melphalan
  arm group label: Autologous hematopoietic stem cell transplantation
  arm group label: Radiotherapy combined with autologous hematopoietic stem cell transplantation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Fuling Zhou
  role: Study Director
  affiliation: Wuhan University
  last name: Fuling Zhou
  phone: +86-02767813137
  email: zhoufuling@whu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Zhongnan Hospital
  investigator full name: Fuling Zhou
  investigator title: Chief physician
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  sharing ipd: No