<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/NCT03283917</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0243</org_study_id>
    <secondary_id>NCI-2018-01044</secondary_id>
    <secondary_id>2017-0243</secondary_id>
    <nct_id>NCT03283917</nct_id>
  </id_info>
  <brief_title>Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis</brief_title>
  <official_title>A Safety Study of Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Janssen Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I trial studies the side effects and best dose of daratumumab, ixazomib, and&#xD;
      dexamethasone in treating participants with amyloid light chain amyloidosis. Monoclonal&#xD;
      antibodies, such as daratumumab, may interfere with the ability of tumor cells to grow and&#xD;
      spread. Drugs used in chemotherapy, such as ixazomib and dexamethasone, work in different&#xD;
      ways to stop the growth of tumor cells, either by killing the cells, by stopping them from&#xD;
      dividing, or by stopping them from spreading. Giving daratumumab, ixazomib, and dexamethasone&#xD;
      may be effective in treating participants with light chain amyloidosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To confirm the safety and tolerability of daratumumab, ixazomib, and dexamethasone (DId)&#xD;
      in patients with amyloid light chain (AL) amyloidosis.&#xD;
&#xD;
      II. To determine the recommended phase 2 dose (RP2D) of daratumumab, ixazomib, and&#xD;
      dexamethasone in subjects with AL amyloidosis.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the hematologic response rate of daratumumab, ixazomib, and dexamethasone in&#xD;
      patients with AL amyloidosis.&#xD;
&#xD;
      II. To determine cardiac and renal organ response rate of daratumumab, ixazomib, and&#xD;
      dexamethasone in patients with AL amyloidosis.&#xD;
&#xD;
      III. To determine time to next therapy. IV. To determine the time to response. V. To&#xD;
      determine the duration of response. VI. To determine progression free survival (PFS). VII. To&#xD;
      determine overall survival (OS).&#xD;
&#xD;
      OUTLINE: This is a dose-escalation study of dexamethasone.&#xD;
&#xD;
      Participants receive daratumumab intravenously (IV) over 3.5-6.5 hours on days 1, 8, 15, and&#xD;
      22 of courses 1-2, on days 1 and 15 of courses 3-6, and on day 1 of courses 7-12.&#xD;
      Participants also receive ixazomib orally (PO) on days 1, 8, and 15, and dexamethasone IV&#xD;
      over 15 minutes or PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12&#xD;
      courses in the absence of disease progression or unaccepted toxicity.&#xD;
&#xD;
      After completion of study treatment, participants are followed up at 30 days and then every&#xD;
      90 days for 24 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 7, 2018</start_date>
  <completion_date type="Anticipated">May 18, 2025</completion_date>
  <primary_completion_date type="Anticipated">May 18, 2025</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</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>Dose limiting toxicity rate</measure>
    <time_frame>Up to 28 days</time_frame>
    <description>Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recommended phase 2 dose of daratumumab, ixazomib, and dexamethasone</measure>
    <time_frame>Up to 24 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall hematologic response rate</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to next therapy</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>Up to 24 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Newly Diagnosed Primary Amyloidosis</condition>
  <condition>Recurrent Primary Amyloidosis</condition>
  <condition>Refractory Primary Amyloidosis</condition>
  <arm_group>
    <arm_group_label>Treatment (daratumumab, ixazomib, dexamethasone)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive daratumumab IV over 3.5-6.5 hours on days 1, 8, 15, and 22 of courses 1-2, on days 1 and 15 of courses 3-6, and on day 1 of courses 7-12. Participants also receive ixazomib PO on days 1, 8, and 15, and dexamethasone IV over 15 minutes or PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unaccepted toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Daratumumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (daratumumab, ixazomib, dexamethasone)</arm_group_label>
    <other_name>Anti-CD38 Monoclonal Antibody</other_name>
    <other_name>Darzalex</other_name>
    <other_name>HuMax-CD38</other_name>
    <other_name>JNJ-54767414</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>Given IV or PO</description>
    <arm_group_label>Treatment (daratumumab, ixazomib, dexamethasone)</arm_group_label>
    <other_name>Aacidexam</other_name>
    <other_name>Adexone</other_name>
    <other_name>Aknichthol Dexa</other_name>
    <other_name>Alba-Dex</other_name>
    <other_name>Alin</other_name>
    <other_name>Alin Depot</other_name>
    <other_name>Alin Oftalmico</other_name>
    <other_name>Amplidermis</other_name>
    <other_name>Anemul mono</other_name>
    <other_name>Auricularum</other_name>
    <other_name>Auxiloson</other_name>
    <other_name>Baycuten</other_name>
    <other_name>Baycuten N</other_name>
    <other_name>Cortidexason</other_name>
    <other_name>Cortisumman</other_name>
    <other_name>Decacort</other_name>
    <other_name>Decadrol</other_name>
    <other_name>Decadron</other_name>
    <other_name>Decalix</other_name>
    <other_name>Decameth</other_name>
    <other_name>Decasone R.p.</other_name>
    <other_name>Dectancyl</other_name>
    <other_name>Dekacort</other_name>
    <other_name>Deltafluorene</other_name>
    <other_name>Deronil</other_name>
    <other_name>Desamethasone</other_name>
    <other_name>Desameton</other_name>
    <other_name>Dexa-Mamallet</other_name>
    <other_name>Dexa-Rhinosan</other_name>
    <other_name>Dexa-Scheroson</other_name>
    <other_name>Dexa-sine</other_name>
    <other_name>Dexacortal</other_name>
    <other_name>Dexacortin</other_name>
    <other_name>Dexafarma</other_name>
    <other_name>Dexafluorene</other_name>
    <other_name>Dexalocal</other_name>
    <other_name>Dexamecortin</other_name>
    <other_name>Dexameth</other_name>
    <other_name>Dexamethasonum</other_name>
    <other_name>Dexamonozon</other_name>
    <other_name>Dexapos</other_name>
    <other_name>Dexinoral</other_name>
    <other_name>Dexone</other_name>
    <other_name>Dinormon</other_name>
    <other_name>Fluorodelta</other_name>
    <other_name>Fortecortin</other_name>
    <other_name>Gammacorten</other_name>
    <other_name>Hexadecadrol</other_name>
    <other_name>Hexadrol</other_name>
    <other_name>Lokalison-F</other_name>
    <other_name>Loverine</other_name>
    <other_name>Methylfluorprednisolone</other_name>
    <other_name>Millicorten</other_name>
    <other_name>Mymethasone</other_name>
    <other_name>Orgadrone</other_name>
    <other_name>Spersadex</other_name>
    <other_name>Visumetazone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ixazomib</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Treatment (daratumumab, ixazomib, dexamethasone)</arm_group_label>
    <other_name>MLN-2238</other_name>
    <other_name>MLN2238</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of primary systemic AL amyloidosis of tissue as determined by: a. Congo red&#xD;
             staining of tissue showing apple green birefringence AND b. Clonal plasma cell&#xD;
             disorder as determined by: i. Immunohistochemistry, in situ hybridization (ISH) or&#xD;
             flow cytometry demonstrating kappa or lambda light chain restriction on bone marrow&#xD;
             biopsy AND/OR ii. Monoclonal protein on serum or urine electrophoresis/immunofixation&#xD;
             OR abnormal free light chain ratio&#xD;
&#xD;
          -  Newly diagnosed OR relapsed and/or refractory AL amyloidosis. Newly diagnosed patients&#xD;
             must be treatment naive without previous plasma cell-directed therapy with the&#xD;
             exception of a maximum of 160 mg dexamethasone or equivalent prior to dosing on&#xD;
             protocol. Relapsed and/or refractory is defined as follows: a. Clonal relapse after at&#xD;
             least one previous line of therapy or high-dose chemotherapy and autologous stem cell&#xD;
             transplantation OR b. Refractory disease to prior therapy defined as less than a&#xD;
             hematologic very good partial response (VGPR). If previous therapy was autologous stem&#xD;
             cell transplant (SCT), must be &gt;= 3 months after SCT&#xD;
&#xD;
          -  Measurable disease defined by: a. Monoclonal protein in the serum or urine by&#xD;
             immunofixation OR plasmacytosis of bone marrow with monoclonal staining for kappa or&#xD;
             lambda light-chain isotype b. dFLC &gt;= 50 mg/L (dFLC=difference in involved and&#xD;
             uninvolved serum free light-chain levels)&#xD;
&#xD;
          -  Voluntary written consent must be given before performance of any study related&#xD;
             procedure not part of standard medical care, with the understanding that consent may&#xD;
             be withdrawn by the patient at any time without prejudice to future medical care&#xD;
&#xD;
          -  Female patients who:&#xD;
&#xD;
               -  Are postmenopausal for at least 1 year before the screening visit, OR&#xD;
&#xD;
               -  Are surgically sterile, OR&#xD;
&#xD;
               -  If they are of childbearing potential, agree to practice 2 effective methods of&#xD;
                  contraception, at the same time, from the time of signing the informed consent&#xD;
                  form through 90 days after the last dose of study drug, OR&#xD;
&#xD;
               -  Agree to practice true abstinence when this is in line with the preferred and&#xD;
                  usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation,&#xD;
                  symptothermal, post-ovulation methods] and withdrawal are not acceptable methods&#xD;
                  of contraception)&#xD;
&#xD;
          -  Male patients, even if surgically sterilized (ie, status post-vasectomy), must agree&#xD;
             to one of the following:&#xD;
&#xD;
               -  Agree to practice effective barrier contraception during the entire study&#xD;
                  treatment period and through 90 days after the last dose of study drug, OR&#xD;
&#xD;
               -  Agree to practice true abstinence when this is in line with the preferred and&#xD;
                  usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation,&#xD;
                  symptothermal, post-ovulation methods] and withdrawal are not acceptable methods&#xD;
                  of contraception)&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance&#xD;
             status 0, 1, or 2&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1,000/mm^3&#xD;
&#xD;
          -  Platelet count &gt;= 75,000/mm^3. Platelet transfusions to help patients meet eligibility&#xD;
             criteria are not allowed within 3 days before study enrollment&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 x the upper limit of the normal range (ULN)&#xD;
&#xD;
          -  Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =&lt; 3 x ULN&#xD;
&#xD;
          -  Calculated creatinine clearance &gt;= 10 mL/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-AL amyloidosis&#xD;
&#xD;
          -  Clinically overt myeloma a.) Lytic bone lesions or biopsy proven plasmacytoma b.)&#xD;
             Hypercalcemia (corrected for albumin) &gt; 11 mg/dL unexplained by other causes&#xD;
&#xD;
          -  Clinically significant cardiac disease defined by any of the following criteria: a.)&#xD;
             New York Heart Association (NYHA) class IV heart failure b.) N-terminal prohormone of&#xD;
             brain natriuretic peptide (NT-ProBNP) &gt; 8500 ng/L c.) Symptomatic orthostatic&#xD;
             hypotension with supine systolic blood pressure &lt; 90 mm Hg d.) Unstable cardiac&#xD;
             arrhythmia e.) Unstable angina f.) Myocardial infarction within the past 6 months&#xD;
&#xD;
          -  Severe obstructive airway disease defined by forced expiratory volume at one second&#xD;
             (FEV1) &lt; 50%&#xD;
&#xD;
          -  Female patients who are lactating or have a positive serum pregnancy test during the&#xD;
             screening period&#xD;
&#xD;
          -  Failure to have fully recovered (ie, =&lt; grade 1 toxicity) from the reversible effects&#xD;
             of prior chemotherapy&#xD;
&#xD;
          -  Major surgery within 14 days before enrollment&#xD;
&#xD;
          -  Radiotherapy within 14 days before enrollment. If the involved field is small, 7 days&#xD;
             will be considered a sufficient interval between treatment and administration of the&#xD;
             ixazomib&#xD;
&#xD;
          -  Infection requiring systemic intravenous antibiotic therapy or other serious infection&#xD;
             within 14 days before study enrollment&#xD;
&#xD;
          -  Systemic treatment, within 14 days before the first dose of and dexamethasone (DId),&#xD;
             with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine,&#xD;
             phenytoin, phenobarbital), or use of Ginkgo biloba or St. John's wort&#xD;
&#xD;
          -  Ongoing or active systemic infection, active hepatitis B or C virus infection, or&#xD;
             known human immunodeficiency virus (HIV) positive&#xD;
&#xD;
          -  Any serious medical or psychiatric illness that could, in the investigator's opinion,&#xD;
             potentially interfere with the completion of treatment according to this protocol&#xD;
&#xD;
          -  Known allergy to any of the study medications, their analogues, or excipients in the&#xD;
             various formulations of any agent&#xD;
&#xD;
          -  Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral&#xD;
             absorption or tolerance of ixazomib including difficulty swallowing&#xD;
&#xD;
          -  Diagnosed or treated for another malignancy within 2 years before study enrollment or&#xD;
             previously diagnosed with another malignancy and have any evidence of residual&#xD;
             disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are&#xD;
             not excluded if they have undergone complete resection&#xD;
&#xD;
          -  Patient has &gt;= grade 3 peripheral neuropathy, or grade 2 with pain on clinical&#xD;
             examination during the screening period&#xD;
&#xD;
          -  Participation in other clinical trials, including those with other investigational&#xD;
             agents not included in this trial, within 30 days of the start of this trial and&#xD;
             throughout the duration of this trial&#xD;
&#xD;
          -  Patients that have previously been treated with daratumumab or ixazomib, or&#xD;
             participated in a study with ixazomib whether treated with ixazomib or not&#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>Hans C Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 13, 2017</study_first_submitted>
  <study_first_submitted_qc>September 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>May 26, 2023</last_update_submitted>
  <last_update_submitted_qc>May 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2023</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>Immunoglobulin Light-chain Amyloidosis</mesh_term>
    <mesh_term>Amyloidosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Daratumumab</mesh_term>
    <mesh_term>Ixazomib</mesh_term>
    <mesh_term>Ichthammol</mesh_term>
    <mesh_term>BB 1101</mesh_term>
    <mesh_term>Glycine</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03283917
org study id: 2017-0243
secondary id: NCI-2018-01044
secondary id: 2017-0243
nct id: NCT03283917
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase I trial studies the side effects and best dose of daratumumab, ixazomib, and
      dexamethasone in treating participants with amyloid light chain amyloidosis. Monoclonal
      antibodies, such as daratumumab, may interfere with the ability of tumor cells to grow and
      spread. Drugs used in chemotherapy, such as ixazomib and dexamethasone, work in different
      ways to stop the growth of tumor cells, either by killing the cells, by stopping them from
      dividing, or by stopping them from spreading. Giving daratumumab, ixazomib, and dexamethasone
      may be effective in treating participants with light chain amyloidosis.
PRIMARY OBJECTIVES:

      I. To confirm the safety and tolerability of daratumumab, ixazomib, and dexamethasone (DId)
      in patients with amyloid light chain (AL) amyloidosis.

      II. To determine the recommended phase 2 dose (RP2D) of daratumumab, ixazomib, and
      dexamethasone in subjects with AL amyloidosis.

      SECONDARY OBJECTIVES:

      I. To determine the hematologic response rate of daratumumab, ixazomib, and dexamethasone in
      patients with AL amyloidosis.

      II. To determine cardiac and renal organ response rate of daratumumab, ixazomib, and
      dexamethasone in patients with AL amyloidosis.

      III. To determine time to next therapy. IV. To determine the time to response. V. To
      determine the duration of response. VI. To determine progression free survival (PFS). VII. To
      determine overall survival (OS).

      OUTLINE: This is a dose-escalation study of dexamethasone.

      Participants receive daratumumab intravenously (IV) over 3.5-6.5 hours on days 1, 8, 15, and
      22 of courses 1-2, on days 1 and 15 of courses 3-6, and on day 1 of courses 7-12.
      Participants also receive ixazomib orally (PO) on days 1, 8, and 15, and dexamethasone IV
      over 15 minutes or PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12
      courses in the absence of disease progression or unaccepted toxicity.

      After completion of study treatment, participants are followed up at 30 days and then every
      90 days for 24 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose limiting toxicity rate
time frame: Up to 28 days
description: Will be assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.
measure: Recommended phase 2 dose of daratumumab, ixazomib, and dexamethasone
time frame: Up to 24 months
measure: Overall hematologic response rate
time frame: Up to 24 months
measure: Time to response
time frame: Up to 24 months
measure: Duration of response
time frame: Up to 24 months
measure: Time to next therapy
time frame: Up to 24 months
measure: Progression free survival
time frame: Up to 24 months
measure: Overall survival
time frame: Up to 24 months
arm group label: Treatment (daratumumab, ixazomib, dexamethasone)
arm group type: Experimental
description: Participants receive daratumumab IV over 3.5-6.5 hours on days 1, 8, 15, and 22 of courses 1-2, on days 1 and 15 of courses 3-6, and on day 1 of courses 7-12. Participants also receive ixazomib PO on days 1, 8, and 15, and dexamethasone IV over 15 minutes or PO on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unaccepted toxicity.
intervention type: Biological
intervention name: Daratumumab
description: Given IV
arm group label: Treatment (daratumumab, ixazomib, dexamethasone)
other name: Anti-CD38 Monoclonal Antibody
other name: Darzalex
other name: HuMax-CD38
other name: JNJ-54767414
intervention type: Drug
intervention name: Dexamethasone
description: Given IV or PO
arm group label: Treatment (daratumumab, ixazomib, dexamethasone)
other name: Aacidexam
other name: Adexone
other name: Aknichthol Dexa
other name: Alba-Dex
other name: Alin
other name: Alin Depot
other name: Alin Oftalmico
other name: Amplidermis
other name: Anemul mono
other name: Auricularum
other name: Auxiloson
other name: Baycuten
other name: Baycuten N
other name: Cortidexason
other name: Cortisumman
other name: Decacort
other name: Decadrol
other name: Decadron
other name: Decalix
other name: Decameth
other name: Decasone R.p.
other name: Dectancyl
other name: Dekacort
other name: Deltafluorene
other name: Deronil
other name: Desamethasone
other name: Desameton
other name: Dexa-Mamallet
other name: Dexa-Rhinosan
other name: Dexa-Scheroson
other name: Dexa-sine
other name: Dexacortal
other name: Dexacortin
other name: Dexafarma
other name: Dexafluorene
other name: Dexalocal
other name: Dexamecortin
other name: Dexameth
other name: Dexamethasonum
other name: Dexamonozon
other name: Dexapos
other name: Dexinoral
other name: Dexone
other name: Dinormon
other name: Fluorodelta
other name: Fortecortin
other name: Gammacorten
other name: Hexadecadrol
other name: Hexadrol
other name: Lokalison-F
other name: Loverine
other name: Methylfluorprednisolone
other name: Millicorten
other name: Mymethasone
other name: Orgadrone
other name: Spersadex
other name: Visumetazone
intervention type: Drug
intervention name: Ixazomib
description: Given PO
arm group label: Treatment (daratumumab, ixazomib, dexamethasone)
other name: MLN-2238
other name: MLN2238
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hans C Lee
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
facility: 
country: United States
url: http://www.mdanderson.org
description: MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Immunoglobulin Light-chain Amyloidosis
mesh term: Amyloidosis
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Daratumumab
mesh term: Ixazomib
mesh term: Ichthammol
mesh term: BB 1101
mesh term: Glycine