<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/NCT03246529</url>
  </required_header>
  <id_info>
    <org_study_id>BL-8040.SCM.301</org_study_id>
    <nct_id>NCT03246529</nct_id>
  </id_info>
  <brief_title>A Phase III, Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-GSF as Compared to Placebo and G-CSF for thE MobilizatioN of HematopoiEtic Stem Cells for Autologous TransplantatIon in SubjectS With MM</brief_title>
  <acronym>GENESIS</acronym>
  <official_title>A Phase III, Randomized, Placebo-Controlled, Multi-Centre Study Evaluating the Safety, Tolerability and Efficacy of Combination Treatment of BL-8040 and G-GSF as Compared to Placebo and G-CSF for thE MobilizatioN of HematopoiEtic Stem Cells for Autologous TransplantatIon in SubjectS With Multiple Myeloma - The GENESIS Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioLineRx, Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioLineRx, Ltd.</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>
      A total of 207 subjects will be randomized into the study which will employ a double-blind&#xD;
      placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared&#xD;
      to G-CSF + placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Part 1: This lead-in period designed to ascertain the dose of BL-8040 will enroll a&#xD;
           total of up to 30 subjects to an open labeled treatment to assess the efficacy, safety,&#xD;
           PK and PD parameters of treatment with G-CSF 10 µg/kg/day and BL-8040 1.25mg/kg, per&#xD;
           study protocol to goal collection of ≥ 6x106 CD34+ cells/kg.&#xD;
&#xD;
        -  Part 2: Following the successful completion of Part 1, a total of 177 subjects will be&#xD;
           randomized into Part 2 of the study which will employ a double-blind placebo-controlled&#xD;
           setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF +&#xD;
           placebo.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 23, 2018</start_date>
  <completion_date type="Anticipated">December 22, 2025</completion_date>
  <primary_completion_date type="Actual">December 22, 2020</primary_completion_date>
  <phase>Phase 3</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>
    <intervention_model_description>subjects will be randomized using a 2:1 ratio to receive G-CSF + BL-8040 or G-CSF + Placebo, respectively. Randomization will use permuted blocks stratifying subjects by US geographical region (NorthEast, SouthEast, MidWest, SouthWest and NorthWest), remission status (CR vs. PR), and baseline platelet count (&lt; 200 X 109/L or ≥ 200 X 109/L).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of subjects mobilizing ≥6.0 x 106 CD34+ cells/kg with up to 2 apheresis sessions</measure>
    <time_frame>18 months</time_frame>
    <description>Proportion of subjects mobilizing ≥6.0 x 106 CD34+ cells/kg with up to 2 apheresis sessions in preparation for auto-HCT after treatment with G-CSF + single administration of BL-8040 or G-CSF + placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who collect ≥2.0 x 106 CD34+ cells/kg in 1 apheresis session</measure>
    <time_frame>18 months</time_frame>
    <description>Proportion of subjects who collect ≥2.0 x 106 CD34+ cells/kg in 1 apheresis session after treatment with G-CSF + single administration of BL-8040 or G-CSF + placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects who collect ≥6.0 x 106 CD34+ cells/kg in 1 apheresis session</measure>
    <time_frame>18 months</time_frame>
    <description>Proportion of subjects who collect ≥6.0 x 106 CD34+ cells/kg in 1 apheresis session after treatment with G-CSF + single administration of BL-8040 or G-CSF + placebo.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to neutrophil engraftment, after autologous hematopoietic cell transplantation</measure>
    <time_frame>18 months</time_frame>
    <description>Time to neutrophil engraftment, after autologous hematopoietic cell transplantation, as defined as ANC ≥0.5 x 109/L for 3 days or ≥1.0 x 109/L for 1 day following the conditioning regimen associated nadir.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to platelet engraftment, after autologous hematopoietic cell transplantation</measure>
    <time_frame>18 months</time_frame>
    <description>Time to platelet engraftment, after autologous hematopoietic cell transplantation, as defined as the first of 3 consecutive measurements of platelet count ≥20 x 109/L without platelet transfusion support for 7 days following the conditioning regimen associated nadir.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft durability at 100 days post engraftment.</measure>
    <time_frame>18 months</time_frame>
    <description>Graft durability at 100 days post engraftment, after autologous hematopoietic cell transplantation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>BL-8040 1.25mg/kg + G-CSF</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>double-blind placebo-controlled setting designed to assess the safety, tolerability and efficacy of G-CSF + BL-8040 as compared to G-CSF + Placebo, for stem cell mobilization in MM.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo + G-CSF</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>double-blind placebo-controlled setting designed to assess the safety, tolerability and efficacy of G-CSF + BL-8040 as compared to G-CSF + Placebo, for stem cell mobilization in MM.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BL-8040 1.25mg/kg + G-CSF</intervention_name>
    <description>Up to 2 SC injections of BL-8040 are anticipated during the study. Injections of G-CSF per standard of care</description>
    <arm_group_label>BL-8040 1.25mg/kg + G-CSF</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo +G-CSF</intervention_name>
    <description>Up to 2 SC injections of Placebo are anticipated during the study. Injections of G-CSF per standard of care</description>
    <arm_group_label>Placebo + G-CSF</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically confirmed Multiple Myeloma prior to enrolment and randomization.&#xD;
&#xD;
          2. At least 1 weeks (7 days) from last induction cycle of combination/multi-agent&#xD;
             cyto-reductive chemotherapy and no single agent chemotherapy/maintenance within 7 days&#xD;
             (e.g. lenalidomide, pomalidomide, bortezomib, dexamethasone, etc).&#xD;
&#xD;
          3. Eligible for Autologous Hematopoietic stem cell transplantation according at the&#xD;
             investigator discretion.&#xD;
&#xD;
          4. The subjects should be in first or second CR (including CR and SCR) or PR (including&#xD;
             PR and VGPR)&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.&#xD;
&#xD;
          6. Adequate organ function at screening .&#xD;
&#xD;
          7. Subjects must use effective contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Previous history of autologous or allogeneic-HCT&#xD;
&#xD;
          2. Failed previous HSC collections or collection attempts.&#xD;
&#xD;
          3. Patients whose apheresis product were to be further selected and purified&#xD;
&#xD;
          4. Taken any of the listed below concomitant medications, growth factors or stimulating&#xD;
             agents within the designated washout period:&#xD;
&#xD;
               1. Dexamethasone: 7 days&#xD;
&#xD;
               2. Thalidomide: 7 days&#xD;
&#xD;
               3. Lenalidomide: 7 days&#xD;
&#xD;
               4. Pamolidomide: 7 days&#xD;
&#xD;
               5. Bortezomib: 7 days&#xD;
&#xD;
               6. Carfilzomib: 7 days&#xD;
&#xD;
               7. G-CSF: 14 days&#xD;
&#xD;
               8. GM-CSF or Neulasta®: 21 days&#xD;
&#xD;
               9. Combination/multi-agent cyto-reductive therapy&#xD;
&#xD;
              10. Erythropoietin or erythrocyte stimulating agents: 30 days&#xD;
&#xD;
              11. Eltrombopag, romiplostim or platelet stimulating agents: 30 days&#xD;
&#xD;
              12. Carmustine (BCNU): 42 days/6 weeks&#xD;
&#xD;
             l. Daratumumab: 28 days m. Ixazomib: 7 days&#xD;
&#xD;
          5. Received &gt;6 cycles lifetime exposure to Lenalidomide.&#xD;
&#xD;
          6. Received &gt;8 cycles of alkylating agent combinations.&#xD;
&#xD;
          7. Received &gt; 6 cycles of melphalan&#xD;
&#xD;
          8. Received 3-bis(2-chloroethyl)-1nitrl.&#xD;
&#xD;
          9. Received prior treatment with radioimmunotherapy, (e.g. radionuclides, holmium).&#xD;
&#xD;
         10. Received marrow stimulating factors:&#xD;
&#xD;
               1. Received G-CSF within 14 days prior to anticipated first dose of G-CSF.&#xD;
&#xD;
               2. Received Pegfilgrastim (GM-CSF or Nulesta) within 3 weeks prior to anticipated&#xD;
                  first dose of G-CSF.&#xD;
&#xD;
         11. Received erythrocyte of platelet stimulating agents within 30 days prior to&#xD;
             anticipated first dose of G-CSF&#xD;
&#xD;
         12. Plans to receive maintenance treatment within 60 days post-engraftment (e.g.&#xD;
             Lenalidomide, Bortezomib, Pomalidomide, Thalidomide, Carfilzomib, etc.)&#xD;
&#xD;
         13. Has received a live vaccine within 30 days of the planned start of study therapy.&#xD;
             Seasonal flu vaccines that do not contain live virus are permitted.&#xD;
&#xD;
         14. Known active CNS metastases or carcinomatous meningitis.&#xD;
&#xD;
         15. A history of allergic reactions attributed to compounds of similar chemical or&#xD;
             biologic composition to BL-8040, G-CSF, or other agents used in the study.&#xD;
&#xD;
         16. Has an active infection requiring systemic therapy or uncontrolled infection. Has a&#xD;
             known additional malignancy that is progressing or requires active treatment. Has an&#xD;
             underlying medical condition that would preclude study participation.&#xD;
&#xD;
         17. Is currently participating and receiving study therapy or has participated in a study&#xD;
             of an investigational agent and received study therapy or used an investigational&#xD;
             device within 4 weeks of the first dose of treatment.&#xD;
&#xD;
         18. O2 saturation &lt; 92% (on room air).&#xD;
&#xD;
         19. History of unexplained syncope, syncope from an uncorrected cardiac etiology, or&#xD;
             family history of sudden death.&#xD;
&#xD;
         20. History or family history of Long QT Syndrome or Torsade de Pointes. Myocardial&#xD;
             infarction, CABG, coronary or cerebral artery stenting and /or angioplasty, stroke,&#xD;
             cardiac surgery, or hospitalization for congestive heart failure within 3 months or&#xD;
             greater than Class 2 Angina Pectoris or NYHA Heart Failure Class &gt;2. QTcF &gt; 470 msec,&#xD;
             PR &gt; 280 msec, Mobitz II 2nd degree AV Block, 2:1 AV Block, High Grade AV Block, or&#xD;
             Complete Heart Block, unless the patient has an implanted pacemaker or implantable&#xD;
             cardiac defibrillator (ICD) with backup pacing capabilities.&#xD;
&#xD;
         21. Has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperation with the requirements of the trial.&#xD;
&#xD;
         22. Is pregnant or breastfeeding, or expecting to conceive or father children within the&#xD;
             projected duration of the trial, starting with the screening visit through 30 days&#xD;
             after the last dose of trial treatment.&#xD;
&#xD;
         23. Has a known history of HIV (HIV 1/2 antibodies), active / chronic Hepatitis B or C.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>78 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John DiPersio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>167817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>100278</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Maryland</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Washington University in St. Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic, Rochester</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>55902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45221</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Texas City</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntsman Cancer Institute \ University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Koln</name>
      <address>
        <city>Köln</city>
        <state>Koln</state>
        <zip>50923</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Hospital of Southern Pest National Institute of Hematology and Infectious Diseases</name>
      <address>
        <city>Budapest</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Debrecen</name>
      <address>
        <city>Debrecen</city>
        <zip>4027</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Div. Clinicizzata di Ematologia - Policlinico Vittorio Emanuele</name>
      <address>
        <city>Catania</city>
        <zip>95124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Div. Clinicizzata di Ematologia - Policlinico Vittorio Emanuele</name>
      <address>
        <city>Reggio Calabria</city>
        <zip>89133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital De La Santa Creu I Sant Pau</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital University Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>135250</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>August 2, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>June 14, 2022</last_update_submitted>
  <last_update_submitted_qc>June 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lenograstim</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>April 27, 2023</submitted>
    <returned>May 25, 2023</returned>
    <submitted>August 2, 2023</submitted>
    <returned>August 25, 2023</returned>
    <submitted>September 4, 2023</submitted>
  </pending_results>
  <!-- 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/NCT03246529
org study id: BL-8040.SCM.301
nct id: NCT03246529
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A total of 207 subjects will be randomized into the study which will employ a double-blind
      placebo-controlled setting to assess the efficacy and safety of G-CSF + BL-8040 as compared
      to G-CSF + placebo.
-  Part 1: This lead-in period designed to ascertain the dose of BL-8040 will enroll a
           total of up to 30 subjects to an open labeled treatment to assess the efficacy, safety,
           PK and PD parameters of treatment with G-CSF 10 µg/kg/day and BL-8040 1.25mg/kg, per
           study protocol to goal collection of ≥ 6x106 CD34+ cells/kg.

        -  Part 2: Following the successful completion of Part 1, a total of 177 subjects will be
           randomized into Part 2 of the study which will employ a double-blind placebo-controlled
           setting to assess the efficacy and safety of G-CSF + BL-8040 as compared to G-CSF +
           placebo.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: subjects will be randomized using a 2:1 ratio to receive G-CSF + BL-8040 or G-CSF + Placebo, respectively. Randomization will use permuted blocks stratifying subjects by US geographical region (NorthEast, SouthEast, MidWest, SouthWest and NorthWest), remission status (CR vs. PR), and baseline platelet count (< 200 X 109/L or ≥ 200 X 109/L).
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Proportion of subjects mobilizing ≥6.0 x 106 CD34+ cells/kg with up to 2 apheresis sessions
time frame: 18 months
description: Proportion of subjects mobilizing ≥6.0 x 106 CD34+ cells/kg with up to 2 apheresis sessions in preparation for auto-HCT after treatment with G-CSF + single administration of BL-8040 or G-CSF + placebo.
measure: Proportion of subjects who collect ≥2.0 x 106 CD34+ cells/kg in 1 apheresis session
time frame: 18 months
description: Proportion of subjects who collect ≥2.0 x 106 CD34+ cells/kg in 1 apheresis session after treatment with G-CSF + single administration of BL-8040 or G-CSF + placebo.
measure: Proportion of subjects who collect ≥6.0 x 106 CD34+ cells/kg in 1 apheresis session
time frame: 18 months
description: Proportion of subjects who collect ≥6.0 x 106 CD34+ cells/kg in 1 apheresis session after treatment with G-CSF + single administration of BL-8040 or G-CSF + placebo.
measure: Time to neutrophil engraftment, after autologous hematopoietic cell transplantation
time frame: 18 months
description: Time to neutrophil engraftment, after autologous hematopoietic cell transplantation, as defined as ANC ≥0.5 x 109/L for 3 days or ≥1.0 x 109/L for 1 day following the conditioning regimen associated nadir.
measure: Time to platelet engraftment, after autologous hematopoietic cell transplantation
time frame: 18 months
description: Time to platelet engraftment, after autologous hematopoietic cell transplantation, as defined as the first of 3 consecutive measurements of platelet count ≥20 x 109/L without platelet transfusion support for 7 days following the conditioning regimen associated nadir.
measure: Graft durability at 100 days post engraftment.
time frame: 18 months
description: Graft durability at 100 days post engraftment, after autologous hematopoietic cell transplantation.
arm group label: BL-8040 1.25mg/kg + G-CSF
arm group type: Experimental
description: double-blind placebo-controlled setting designed to assess the safety, tolerability and efficacy of G-CSF + BL-8040 as compared to G-CSF + Placebo, for stem cell mobilization in MM.
arm group label: Placebo + G-CSF
arm group type: Active Comparator
description: double-blind placebo-controlled setting designed to assess the safety, tolerability and efficacy of G-CSF + BL-8040 as compared to G-CSF + Placebo, for stem cell mobilization in MM.
intervention type: Drug
intervention name: BL-8040 1.25mg/kg + G-CSF
description: Up to 2 SC injections of BL-8040 are anticipated during the study. Injections of G-CSF per standard of care
arm group label: BL-8040 1.25mg/kg + G-CSF
intervention type: Drug
intervention name: Placebo +G-CSF
description: Up to 2 SC injections of Placebo are anticipated during the study. Injections of G-CSF per standard of care
arm group label: Placebo + G-CSF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 78 Years
healthy volunteers: No
last name: John DiPersio, MD
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Germany
country: Hungary
country: Italy
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Lenograstim
sharing ipd: No
submitted: April 27, 2023
returned: May 25, 2023
submitted: August 2, 2023
returned: August 25, 2023
submitted: September 4, 2023