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/NCT05982275</url>
    </required_header>
    <id_info>
      <org_study_id>CARTemis-1</org_study_id>
      <nct_id>NCT05982275</nct_id>
    </id_info>
    <brief_title>Trial of an Investigational Drug After Rejecting the Rejection of an Allogeneic Transplant</brief_title>
    <acronym>CARTemis-1</acronym>
    <official_title>Anti-BCMA Chimeric Antigen Receptor T-lymphocyte Therapy in Patients With Multiple Myeloma in Relapse After Allogeneic Transplant</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fundación Pública Andaluza para la gestión de la Investigación en Sevilla</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fundación Pública Andaluza para la gestión de la Investigación en Sevilla</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Most patients with multiple myeloma (MM) die due to relapse resistant to current treatment,&#xD;
        including treatment with anti-B cell maturation antigen (BCMA) CAR-T cells. To overcome some&#xD;
        of the potential limitations of this therapy, a new and optimized Anti-BCMA CAR-T has been&#xD;
        developed, with the aim of using it in patients with MM who relapse after Allogeneic&#xD;
        Haematopoietic Haematopoietic Progenitor. This trial is a prospective phase I/II trial with a&#xD;
        3+3 design. Once Dose Limiting Toxicity is identified, Phase II will begin to assess the&#xD;
        efficacy of the procedure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This trial is a prospective phase I/II trial with a 3+3 design. Once Dose Limiting Toxicity&#xD;
        is identified (up to a maximum dose of 6x106 CAR-T/kg divided over 2 days), phase II of the&#xD;
        trial will begin to assess the efficacy of the procedure.&#xD;
  &#xD;
        A number of 25 patients will be included to evaluate.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2028</primary_completion_date>
    <phase>Phase 1/Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Purity of CARTemis-1</measure>
      <time_frame>Immediately after infusion</time_frame>
      <description>Number of cases in which, after performing apheresis, the manufacturing process is completed and CARTemis-1 cells are infused</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Maximum tolerated dose</measure>
      <time_frame>Up to 30 days</time_frame>
      <description>To determine the maximum tolerated dose of CarTemis-1</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Infusion reactions</measure>
      <time_frame>Immediately after intravenous administration of CARTemis-1</time_frame>
      <description>To appearance of any of the following symptoms after intravenous administration of CARTemis-1: cardiac events, chills, dyspnea, fatigue, sudden hypertension, hypotension, nausea, pain, fever, skin rash, and urticaria.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Tumor lysis syndrome</measure>
      <time_frame>Up to 30 days after treatment administration</time_frame>
      <description>To increase nucleic acids, potassium, and phosphate in the blood</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Serious Adverse Event</measure>
      <time_frame>Up to 36 months after treatment administration</time_frame>
      <description>Type, incidence, severity (graded by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0), timing, intensity, and relatedness of adverse events).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Suspected Unexpected Serious Adverse Reaction</measure>
      <time_frame>Up to 36 months after treatment administration</time_frame>
      <description>Describe the adverse event that occurs in a clinical trial subject, which is assessed by the sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with cytopenias</measure>
      <time_frame>During the first 90 days after administration of CARTemis-1</time_frame>
      <description>Neutropenias or thrombopenias</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of Participants with prolonged cytopenias</measure>
      <time_frame>Up to 12 months after treatment administration</time_frame>
      <description>Neutropenias or thrombopenias (grade ≥3) for more than 6 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of clinical response</measure>
      <time_frame>Screening, day -5, -4, -3, +28, +56, +100 and months +4, +5, 6, +7, +8, +9, +10, +11, +12, +15 , +18, +21, +27, +30, +33, +36 or progression</time_frame>
      <description>Duration of clinical response as assessed by Urinalysis (immunofixation, proteinuria and 24-h urine proteinogram), Blood tests (total immunoglobulin A, G and M, immunofixation and proteinogram (M component) in serum; serum free light chains), Bone Marrow Aspirate and Positron Emission Tomography.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall response rate</measure>
      <time_frame>3, 6 and 12 months after CARTemis-1 infusion</time_frame>
      <description>Overall response rate as assessed by criteria of the International Myeloma Working Group</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to complete remission</measure>
      <time_frame>Up to 36 months after treatment administration</time_frame>
      <description>Duration of clinical response as assessed by Urinalysis (immunofixation, proteinuria and 24-h urine proteinogram), Blood tests (total immunoglobulin A, G and M, immunofixation and proteinogram (M component) in serum; serum free light chains), Bone Marrow Aspirate and Positron Emission Tomography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to best response</measure>
      <time_frame>Up to 36 months after treatment administration</time_frame>
      <description>Duration of clinical response as assessed by Urinalysis (immunofixation, proteinuria and 24-h urine proteinogram), Blood tests (total immunoglobulin A, G and M, immunofixation and proteinogram (M component) in serum; serum free light chains), Bone Marrow Aspirate and Positron Emission Tomography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Negative Minimum Residual Disease Rate</measure>
      <time_frame>3, 6 and 12 months after CARTemis-1 infusion</time_frame>
      <description>Residual amount of malignant cells in the bone marrow</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Response rate of extramedullary disease</measure>
      <time_frame>3 months after CARTemis-1 infusion</time_frame>
      <description>To measure of the metabolic activity of the human body by Positron Emission Tomography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival.</measure>
      <time_frame>Up to 36 months after treatment administration</time_frame>
      <description>Quantification of time between administration of CARTemis-1 and disease progression or death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>Up to 36 months after treatment administration</time_frame>
      <description>the time elapsed between the infusion of CARTemis-1 and the patient's death from any cause.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Persistence of CARTemis-1</measure>
      <time_frame>Peripheral blood:days 3,7,10,14,17 (only in cohort 3 and 4),21,30,56,90,128 and 156, and months 6,9,12,15,18,24 and relapse or month 36 post-infusion; Marrow: 1,3,6,12,18 and 24 months post-infusion and in the progression or month</time_frame>
      <description>Presence of CARTemis-1 in peripheral blood and bone marrow</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CART cell quality</measure>
      <time_frame>During the manufacturing process, at the time of infusion and at Month+1, Month+3, Month+6, Month+12, Month+18 and Month+24 post-infusion</time_frame>
      <description>Evaluation of the biological characteristics of CARTemis-1 performed by flow cytometry to identify the optimal time of expansion as well as to study the dynamics of CAR T cells during the manufacturing process and how the manufacturing impacts on CAR T cell features and, therefore, CAR T cell quality.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Expression of B cell maturation antigen (BCMA)</measure>
      <time_frame>Screening and at the time of follow up when a relapse occurs, an average after 1 year</time_frame>
      <description>Genetic expression of BCMA at selection and at relapse in patients</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>B cell maturation antigen (BCMA) levels</measure>
      <time_frame>Screening, Day -5, Day 0, +1, +3, +7 y +28 and months +3, +6, +12, +18 and +24</time_frame>
      <description>Serum soluble BCMA levels pre-treatment and during treatment</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Multiple Myeloma</condition>
    <condition>Allogeneic Stem Cell Transplantation</condition>
    <arm_group>
      <arm_group_label>CARTemis-1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Dose escalation sequential cohorts CARTemis-1 will be self-administered intravenously one or two days, depending on the dose administered.</description>
    </arm_group>
    <intervention>
      <intervention_type>Genetic</intervention_type>
      <intervention_name>CARTemis-1</intervention_name>
      <description>A dose escalation design will be applied in successive patient cohorts until identification of Dose Limiting Toxicity (maximum dose: 6x10^6 CAR-T/kg divided over 2 days).</description>
      <arm_group_label>CARTemis-1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients &gt; 18 years old with a diagnosis of post-allogeneic transplant relapse&#xD;
               multiple myeloma.&#xD;
  &#xD;
            2. Measurable disease at the time of screening&#xD;
  &#xD;
            3. Previous treatment with ≥2 lines before and/or after allogeneic transplant.&#xD;
  &#xD;
            4. Patients who are not receiving immunosuppressants at least 1 month before inclusion&#xD;
               and who do not have active graft-versus-host disease.&#xD;
  &#xD;
            5. Eastern Cooperative Oncology Group functional status from 0 to 1.&#xD;
  &#xD;
            6. Life expectancy greater than 3 months (at the time of screening)&#xD;
  &#xD;
            7. Patients who give their consent by signing the Informed Consent document.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Active systemic immunosuppressive treatment&#xD;
  &#xD;
            2. Patients who have previously received treatment with CAR-T Anti-BCMA.&#xD;
  &#xD;
            3. Absolute lymphocyte count &lt;0.2x109/L&#xD;
  &#xD;
            4. Previous neoplasm, except if it has been in complete remission &gt;3 years, with the&#xD;
               exception of skin carcinoma (non-melanoma)&#xD;
  &#xD;
            5. Active infection requiring treatment.&#xD;
  &#xD;
            6. Active HIV, hepatitis B virus or hepatitis C virus infection.&#xD;
  &#xD;
            7. Uncontrolled medical illness.&#xD;
  &#xD;
            8. Severe organic disease that meets any of the following criteria: left ventricular&#xD;
               ejection fraction &lt;40%, carbon monoxide diffusion test &lt;40%, glomerular filtration&#xD;
               rate &lt;50 ml/min, bilirubin &gt;3 normal value (except Gilbert syndrome).&#xD;
  &#xD;
            9. Previous diagnosis of symptomatic amyloid light chain or primary amyloidosis or POEMS&#xD;
               Syndrome.&#xD;
  &#xD;
           10. Pregnant or lactating women.&#xD;
  &#xD;
           11. Women of childbearing age, unable or unwilling to use highly effective contraceptive&#xD;
               methods.&#xD;
  &#xD;
           12. Men who cannot or do not wish to use highly effective contraceptive methods.&#xD;
  &#xD;
           13. Contraindication to receive lymphodepleting chemotherapy.&#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>Jose-Antonio Perez-Simon, MD-PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hospitales Universitarios Virgen del Rocío</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jose-Antonio Perez-Simon, MD-PhD</last_name>
      <phone>0034955013414</phone>
      <email>josea.perez.simon.sspa@juntadeandalucia.es</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Clara Rosso, MD-PhD</last_name>
      <phone>0034955013414</phone>
      <email>claram.rosso.sspa@juntadeandalucia.es</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hospital Universitario Marques de Valdecilla</name>
        <address>
          <city>Santander</city>
          <state>Cantabria</state>
          <zip>39008</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Aranzazu Bermúdez-Rodríguez, M.D. Ph.D.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Santa Creu i Sant Pau</name>
        <address>
          <city>Barcelona</city>
          <zip>08025</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Javier Briones, MD-PhD</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Complejo asistencial universitario de Salamanca</name>
        <address>
          <city>Salamanca</city>
          <zip>37007</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Mª Victoria Mateos, MD-Phd</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>José Antonio Pérez Simón</name>
        <address>
          <city>Sevilla</city>
          <zip>41011</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>José Antonio Pérez Simón, MD-PhD</last_name>
        <phone>0034955013260</phone>
        <email>josea.perez.simon.sspa@juntadeandalucia.es</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Clínico de Valencia</name>
        <address>
          <city>Valencia</city>
          <zip>46010</zip>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Carlos Solano Vercet, M.D. Ph.D.</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Chimeric antigen receptor-T cell therapy</keyword>
    <keyword>B-Cell Maturation Antigen</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>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The results will be shared with the investigators involved in the study, and will be shared when the analysis of the results is performed.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>Along the study</ipd_time_frame>
      <ipd_access_criteria>Direct collaborators within the study</ipd_access_criteria>
    </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/NCT05982275
  org study id: CARTemis-1
  nct id: NCT05982275
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Most patients with multiple myeloma (MM) die due to relapse resistant to current treatment,
        including treatment with anti-B cell maturation antigen (BCMA) CAR-T cells. To overcome some
        of the potential limitations of this therapy, a new and optimized Anti-BCMA CAR-T has been
        developed, with the aim of using it in patients with MM who relapse after Allogeneic
        Haematopoietic Haematopoietic Progenitor. This trial is a prospective phase I/II trial with a
        3+3 design. Once Dose Limiting Toxicity is identified, Phase II will begin to assess the
        efficacy of the procedure.
  This trial is a prospective phase I/II trial with a 3+3 design. Once Dose Limiting Toxicity
        is identified (up to a maximum dose of 6x106 CAR-T/kg divided over 2 days), phase II of the
        trial will begin to assess the efficacy of the procedure.
  
        A number of 25 patients will be included to evaluate.
  allocation: N/A
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Purity of CARTemis-1
  time frame: Immediately after infusion
  description: Number of cases in which, after performing apheresis, the manufacturing process is completed and CARTemis-1 cells are infused
  measure: Maximum tolerated dose
  time frame: Up to 30 days
  description: To determine the maximum tolerated dose of CarTemis-1
  measure: Infusion reactions
  time frame: Immediately after intravenous administration of CARTemis-1
  description: To appearance of any of the following symptoms after intravenous administration of CARTemis-1: cardiac events, chills, dyspnea, fatigue, sudden hypertension, hypotension, nausea, pain, fever, skin rash, and urticaria.
  measure: Tumor lysis syndrome
  time frame: Up to 30 days after treatment administration
  description: To increase nucleic acids, potassium, and phosphate in the blood
  measure: Serious Adverse Event
  time frame: Up to 36 months after treatment administration
  description: Type, incidence, severity (graded by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0), timing, intensity, and relatedness of adverse events).
  measure: Suspected Unexpected Serious Adverse Reaction
  time frame: Up to 36 months after treatment administration
  description: Describe the adverse event that occurs in a clinical trial subject, which is assessed by the sponsor and or study investigator as being unexpected, serious and as having a reasonable possibility of a causal relationship with the study drug.
  measure: Number of Participants with cytopenias
  time frame: During the first 90 days after administration of CARTemis-1
  description: Neutropenias or thrombopenias
  measure: Number of Participants with prolonged cytopenias
  time frame: Up to 12 months after treatment administration
  description: Neutropenias or thrombopenias (grade ≥3) for more than 6 weeks
  measure: Duration of clinical response
  time frame: Screening, day -5, -4, -3, +28, +56, +100 and months +4, +5, 6, +7, +8, +9, +10, +11, +12, +15 , +18, +21, +27, +30, +33, +36 or progression
  description: Duration of clinical response as assessed by Urinalysis (immunofixation, proteinuria and 24-h urine proteinogram), Blood tests (total immunoglobulin A, G and M, immunofixation and proteinogram (M component) in serum; serum free light chains), Bone Marrow Aspirate and Positron Emission Tomography.
  measure: Overall response rate
  time frame: 3, 6 and 12 months after CARTemis-1 infusion
  description: Overall response rate as assessed by criteria of the International Myeloma Working Group
  measure: Time to complete remission
  time frame: Up to 36 months after treatment administration
  description: Duration of clinical response as assessed by Urinalysis (immunofixation, proteinuria and 24-h urine proteinogram), Blood tests (total immunoglobulin A, G and M, immunofixation and proteinogram (M component) in serum; serum free light chains), Bone Marrow Aspirate and Positron Emission Tomography
  measure: Time to best response
  time frame: Up to 36 months after treatment administration
  description: Duration of clinical response as assessed by Urinalysis (immunofixation, proteinuria and 24-h urine proteinogram), Blood tests (total immunoglobulin A, G and M, immunofixation and proteinogram (M component) in serum; serum free light chains), Bone Marrow Aspirate and Positron Emission Tomography
  measure: Negative Minimum Residual Disease Rate
  time frame: 3, 6 and 12 months after CARTemis-1 infusion
  description: Residual amount of malignant cells in the bone marrow
  measure: Response rate of extramedullary disease
  time frame: 3 months after CARTemis-1 infusion
  description: To measure of the metabolic activity of the human body by Positron Emission Tomography
  measure: Progression-free survival.
  time frame: Up to 36 months after treatment administration
  description: Quantification of time between administration of CARTemis-1 and disease progression or death
  measure: Overall survival
  time frame: Up to 36 months after treatment administration
  description: the time elapsed between the infusion of CARTemis-1 and the patient's death from any cause.
  measure: Persistence of CARTemis-1
  time frame: Peripheral blood:days 3,7,10,14,17 (only in cohort 3 and 4),21,30,56,90,128 and 156, and months 6,9,12,15,18,24 and relapse or month 36 post-infusion; Marrow: 1,3,6,12,18 and 24 months post-infusion and in the progression or month
  description: Presence of CARTemis-1 in peripheral blood and bone marrow
  measure: CART cell quality
  time frame: During the manufacturing process, at the time of infusion and at Month+1, Month+3, Month+6, Month+12, Month+18 and Month+24 post-infusion
  description: Evaluation of the biological characteristics of CARTemis-1 performed by flow cytometry to identify the optimal time of expansion as well as to study the dynamics of CAR T cells during the manufacturing process and how the manufacturing impacts on CAR T cell features and, therefore, CAR T cell quality.
  measure: Expression of B cell maturation antigen (BCMA)
  time frame: Screening and at the time of follow up when a relapse occurs, an average after 1 year
  description: Genetic expression of BCMA at selection and at relapse in patients
  measure: B cell maturation antigen (BCMA) levels
  time frame: Screening, Day -5, Day 0, +1, +3, +7 y +28 and months +3, +6, +12, +18 and +24
  description: Serum soluble BCMA levels pre-treatment and during treatment
  arm group label: CARTemis-1
  arm group type: Experimental
  description: Dose escalation sequential cohorts CARTemis-1 will be self-administered intravenously one or two days, depending on the dose administered.
  intervention type: Genetic
  intervention name: CARTemis-1
  description: A dose escalation design will be applied in successive patient cohorts until identification of Dose Limiting Toxicity (maximum dose: 6x10^6 CAR-T/kg divided over 2 days).
  arm group label: CARTemis-1
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jose-Antonio Perez-Simon, MD-PhD
  role: Principal Investigator
  affiliation: Hospitales Universitarios Virgen del Rocío
  last name: Jose-Antonio Perez-Simon, MD-PhD
  phone: 0034955013414
  email: josea.perez.simon.sspa@juntadeandalucia.es
  last name: Clara Rosso, MD-PhD
  phone: 0034955013414
  email: claram.rosso.sspa@juntadeandalucia.es
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: Spain
  responsible party type: Sponsor
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  sharing ipd: Yes
  ipd description: The results will be shared with the investigators involved in the study, and will be shared when the analysis of the results is performed.
  ipd info type: Study Protocol
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: Along the study
  ipd access criteria: Direct collaborators within the study