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/NCT05981209</url>
    </required_header>
    <id_info>
      <org_study_id>OSU-22207</org_study_id>
      <secondary_id>NCI-2023-05518</secondary_id>
      <nct_id>NCT05981209</nct_id>
    </id_info>
    <brief_title>Elotuzumab, CC-92480, and Dexamethasone for the Treatment of Relapsed or Refractory Myeloma After CD38- and BCMA-Targeted Therapies</brief_title>
    <official_title>Safety and Efficacy of Elotuzumab, CC-92480, and Dexamethasone in Relapsed/Refractory Myeloma After CD38- and BCMA-Targeted Therapies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Abdullah Khan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ohio State University Comprehensive Cancer Center</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>
        This phase Ib trial tests the safety, side effects, and best dose of CC-92480 in combination&#xD;
        with elotuzumab and dexamethasone in treating patients with multiple myeloma that has come&#xD;
        back after a period of improvement (relapsed) or that does not respond to treatment or has&#xD;
        not responded to previous treatment (refractory). Multiple myeloma (MM) remains the second&#xD;
        most common hematologic malignancy in the United States. A number of therapies have been&#xD;
        approved for patients with MM, including CD38- and B-cell maturating antigen (BCMA)-targeted&#xD;
        therapies (antibody and plasma cell treatments that help the body's immune system to kill&#xD;
        cancer cells); however, patients will often relapse and become refractory to these therapies.&#xD;
        Because of this, it is important to identify effective treatment options for patients&#xD;
        progressing on anti-CD38 therapy and BCMA-directed therapies. Elotuzumab is a humanized IgG1&#xD;
        monoclonal antibody, which is a type of protein that can bind to other target cells to&#xD;
        prevent them from working the way they should or cause them to act differently. Elotuzumab&#xD;
        works by targeting a protein called SLAMF7, which is present on myeloma cells, and makes it&#xD;
        easier for the immune system to target the cancer. CC-92480 works by binding to a protein&#xD;
        called CRBN that triggers the breakdown of proteins: Ikaros and Aiolos, leading to cell death&#xD;
        in multiple myeloma cells. Dexamethasone is a synthetic adrenocortical steroid, or steroid&#xD;
        normally naturally made by the adrenal gland in the brain which has been produced in a&#xD;
        laboratory, that helps to regulate the amount of different chemicals and water that are being&#xD;
        processed by the kidneys. It is also used in patients with myeloma to help treat their&#xD;
        disease. The combination of CC-92480 with elotuzumab and dexamethasone may be a safe and&#xD;
        effective treatment when given to patients with relapsed or recurrent MM.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        PRIMARY OBJECTIVE:&#xD;
  &#xD;
        I. To evaluate the safety and tolerability of elotuzumab, mezigdomide (CC-92480), and&#xD;
        dexamethasone (E480d) in patients with relapsed/refractory multiple myeloma (RRMM) who have&#xD;
        received &gt;= 2 prior regimens including CD38- and BCMA-targeted therapies.&#xD;
  &#xD;
        SECONDARY OBJECTIVES:&#xD;
  &#xD;
        I. To evaluate the objective response rate (ORR) (per International Myeloma Working Group&#xD;
        [IMWG] criteria) of E480d.&#xD;
  &#xD;
        II. Determine the time to response (TTR), the duration of response (DOR), progression free&#xD;
        survival (PFS) at 1 year, and overall survival (OS) at 1 year.&#xD;
  &#xD;
        III. Check minimal residual disease (MRD) negativity rates by next generation sequencing in&#xD;
        patients who are suspected of attaining a complete response (CR).&#xD;
  &#xD;
        IV. Correlative studies will include changes in lymphocyte subsets with therapy,&#xD;
        immunophenotype of MM cells, and expression of CRBN, Ikaros, and Aiolos.&#xD;
  &#xD;
        V. Quality of life (QOL) will be assessed.&#xD;
  &#xD;
        OUTLINE: This is a dose-escalation study of CC-92480, followed by a dose-expansion study.&#xD;
  &#xD;
        Patients receive elotuzumab intravenously (IV) on days 1, 8, 15, and 22 of cycles 1 and 2 and&#xD;
        then on day 1 of each subsequent cycle. Patients also receive CC-92480 orally (PO) on days&#xD;
        1-21 of each cycle and dexamethasone IV or PO on days 1, 8, 15, and 22 of each cycle. Cycles&#xD;
        repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients&#xD;
        may undergo an echocardiography (ECHO) during screening and undergo magnetic resonance&#xD;
        imaging (MRI), computed tomography (CT), or x-ray imaging during screening and on study as&#xD;
        clinically indicated. Patients also undergo blood sample collection as well as bone marrow&#xD;
        biopsy and aspiration during screening and on study.&#xD;
  &#xD;
        After completion of study treatment, patients are followed up at 30 and 60 days and then&#xD;
        every 12 weeks for up to 2 years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <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>The recommended phase 2 dose of mezigdomide (CC-92480) in combination with elotuzumab and dexamethasone</measure>
      <time_frame>Up to 28 days (Cycle 1)</time_frame>
      <description>The dose limiting toxicity (DLT) will be defined as one or more of the following toxicities considered to be at least possibly related to the study drug, occurring during cycle 1 of therapy. Furthermore, inability to take &gt;= 75% of the planned CC-92480 doses, or receive cycle 2 day 1 doses due to a drug-related adverse event occurring in cycle 1 will be considered a DLT.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of adverse events</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Adverse events and toxicities of the combination regimen will be summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be assessed overall, as well as by dose level. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of severe (grade 3+) adverse events or toxicities will be described. Will also assess tolerability of the regimen through assessing the number of patients who required dose modifications and/or dose delays. In addition, will capture the proportion of patients who go off treatment due to adverse reactions. All patients who have received at least one dose of any of the study regimen will be evaluable for toxicity.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR)</measure>
      <time_frame>At 1 year</time_frame>
      <description>Defined as the total number of subjects whose best response is partial response (PR) or better divided by the number of patients. Primary evaluation of antitumor activity of study treatment will be assessed according to International Myeloma Working Group (IMWG) response criteria. ORR will be calculated as a proportion of patients achieved a response. ORR will be reported overall as well as by dose level, with 95% binomial exact confidence intervals (CIs). Comparison of ORR among patient subgroups will be conducted using Fisher exact test.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to progression (TTP)</measure>
      <time_frame>From start of treatment until objective tumor progression; with death as a competing risk, assessed at 1 year</time_frame>
      <description>Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. For TTP, cumulative incidence rates will be calculated and compared using Gray's test accounting for competing risks.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to response (TTR)</measure>
      <time_frame>From start of treatment until measurement criteria are first met for PR, very good partial response (VGPR), or complete response (CR) (whichever status is recorded first), assessed at 1 year</time_frame>
      <description>Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. For TTR, cumulative incidence rates will be calculated and compared using Gray's test accounting for competing risks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR)</measure>
      <time_frame>From the time measurement criteria are first met for partial response or better (whichever status is recorded first) until the first date of progressive disease or death, assessed at 1 year</time_frame>
      <description>DOR will be computed for subjects whose best response is either PR, VGPR, or CR. Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. DOR will be analyzed using the Kaplan-Meier method. The probability of survival and median DOR will be calculated together with 95% CIs, and log-rank test will be used for the comparison between patient subgroups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression free survival (PFS)</measure>
      <time_frame>From start of treatment until disease progression or death, assessed at 1 year</time_frame>
      <description>Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. PFS will be analyzed using the Kaplan-Meier method. The probability of survival and median PFS will be calculated together with 95% CIs, and log-rank test will be used for the comparison between patient subgroups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall survival (OS)</measure>
      <time_frame>From start of treatment to the date of his or her death, assessed at 1 year</time_frame>
      <description>Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. OS will be analyzed using the Kaplan-Meier method. The probability of survival and median OS will be calculated together with 95% CIs, and log-rank test will be used for the comparison between patient subgroups.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimal residual disease (MRD)</measure>
      <time_frame>At final study visit, up to 2 years</time_frame>
      <description>Planned for patients suspected of attaining CR. MRD negativity is associated with superior outcomes compared to MRD positivity.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in lymphocyte subsets with therapy</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Changes in expression of these markers across time will be explored by dose level graphically. Relationships between changes in lymphocyte subsets, total number and ratio of regulatory T cells will be explored graphically (e.g. side-by-side boxplots) and with quantitative summaries, compared using Mann-Whitney test or Fisher exact test depending on the data type of expression data.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in immunophenotype of multiple myeloma cells</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Correlative studies including the changes in expression of these markers across time will be explored by dose level graphically.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in expression of CRBN, Ikaros, and Aiolos with therapy</measure>
      <time_frame>Up to 2 years</time_frame>
      <description>Changes in expression of these markers across time will be explored by dose level graphically.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of life (QOL)</measure>
      <time_frame>At baseline and monthly until study completion, up to 2 years</time_frame>
      <description>Measured with the Patient-Reported Outcomes Measurement Information System Global 10 Quality of Life Survey and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma20. A repeated measures linear mixed model will be fit to all QOL scores. The model will include all time points (baseline as reference session 0 and 1-6 or higher for each monthly measure), and a patient-level random effect. A p-value for the difference between baseline QOL and QOL at the end of the study will be obtained from the model, and if the positive difference with p-value is &lt; 0.05 QOL will be seen as improved.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">27</enrollment>
    <condition>Recurrent Multiple Myeloma</condition>
    <condition>Refractory Multiple Myeloma</condition>
    <arm_group>
      <arm_group_label>Treatment (elotuzumab, CC-92480, dexamethasone)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients receive elotuzumab IV on days 1, 8, 15, and 22 of cycles 1 and 2 and then on day 1 of each subsequent cycle. Patients also receive CC-92480 PO on days 1-21 of each cycle and dexamethasone IV or PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo an ECHO during screening and undergo MRI, CT, or x-ray imaging during screening and on study as clinically indicated. Patients also undergo blood sample collection as well as bone marrow biopsy and aspiration during screening and on study.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Biospecimen Collection</intervention_name>
      <description>Undergo blood sample collection</description>
      <arm_group_label>Treatment (elotuzumab, CC-92480, dexamethasone)</arm_group_label>
      <other_name>Biological Sample Collection</other_name>
      <other_name>Biospecimen Collected</other_name>
      <other_name>Specimen Collection</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Bone Marrow Aspiration</intervention_name>
      <description>Undergo bone marrow biopsy and aspiration</description>
      <arm_group_label>Treatment (elotuzumab, CC-92480, dexamethasone)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Bone Marrow Biopsy</intervention_name>
      <description>Undergo bone marrow biopsy and aspiration</description>
      <arm_group_label>Treatment (elotuzumab, CC-92480, dexamethasone)</arm_group_label>
      <other_name>Biopsy of Bone Marrow</other_name>
      <other_name>Biopsy, Bone Marrow</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Computed Tomography</intervention_name>
      <description>Undergo CT</description>
      <arm_group_label>Treatment (elotuzumab, CC-92480, dexamethasone)</arm_group_label>
      <other_name>CAT</other_name>
      <other_name>CAT Scan</other_name>
      <other_name>Computed Axial Tomography</other_name>
      <other_name>Computerized Axial Tomography</other_name>
      <other_name>Computerized axial tomography (procedure)</other_name>
      <other_name>Computerized Tomography</other_name>
      <other_name>CT</other_name>
      <other_name>CT Scan</other_name>
      <other_name>tomography</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone</intervention_name>
      <description>Given IV or PO</description>
      <arm_group_label>Treatment (elotuzumab, CC-92480, 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>Baycadron</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>Decadron DP</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>Dexamethasone Intensol</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>Dxevo</other_name>
      <other_name>Fluorodelta</other_name>
      <other_name>Fortecortin</other_name>
      <other_name>Gammacorten</other_name>
      <other_name>Hemady</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>TaperDex</other_name>
      <other_name>Visumetazone</other_name>
      <other_name>ZoDex</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Echocardiography</intervention_name>
      <description>Undergo ECHO</description>
      <arm_group_label>Treatment (elotuzumab, CC-92480, dexamethasone)</arm_group_label>
      <other_name>EC</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Elotuzumab</intervention_name>
      <description>Given IV</description>
      <arm_group_label>Treatment (elotuzumab, CC-92480, dexamethasone)</arm_group_label>
      <other_name>BMS-901608</other_name>
      <other_name>Empliciti</other_name>
      <other_name>HuLuc-63</other_name>
      <other_name>HuLuc63</other_name>
      <other_name>PDL-063</other_name>
      <other_name>PDL063</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Magnetic Resonance Imaging</intervention_name>
      <description>Undergo MRI</description>
      <arm_group_label>Treatment (elotuzumab, CC-92480, dexamethasone)</arm_group_label>
      <other_name>Magnetic Resonance</other_name>
      <other_name>Magnetic resonance imaging (procedure)</other_name>
      <other_name>Magnetic Resonance Imaging Scan</other_name>
      <other_name>Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance</other_name>
      <other_name>MR</other_name>
      <other_name>MR Imaging</other_name>
      <other_name>MRI</other_name>
      <other_name>MRI Scan</other_name>
      <other_name>NMR Imaging</other_name>
      <other_name>NMRI</other_name>
      <other_name>Nuclear Magnetic Resonance Imaging</other_name>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Mezigdomide</intervention_name>
      <description>Given PO</description>
      <arm_group_label>Treatment (elotuzumab, CC-92480, dexamethasone)</arm_group_label>
      <other_name>BMS 986348</other_name>
      <other_name>BMS-986348</other_name>
      <other_name>BMS986348</other_name>
      <other_name>CC 92480</other_name>
      <other_name>CC-92480</other_name>
      <other_name>CELMoD CC-92480</other_name>
      <other_name>Cereblon E3 Ligase Modulation Drug CC-92480</other_name>
      <other_name>Cereblon E3 Ubiquitin Ligase Modulating Agent CC-92480</other_name>
      <other_name>Cereblon Modulator CC-92480</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>X-Ray Imaging</intervention_name>
      <description>Undergo x-ray imaging</description>
      <arm_group_label>Treatment (elotuzumab, CC-92480, dexamethasone)</arm_group_label>
      <other_name>Conventional X-Ray</other_name>
      <other_name>Diagnostic Radiology</other_name>
      <other_name>Medical Imaging, X-Ray</other_name>
      <other_name>Plain film radiographs</other_name>
      <other_name>Radiographic Imaging</other_name>
      <other_name>Radiographic imaging procedure (procedure)</other_name>
      <other_name>Radiography</other_name>
      <other_name>RG</other_name>
      <other_name>Static X-Ray</other_name>
      <other_name>X-Ray</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients 18 years of age or older with evidence of relapsed or refractory disease as&#xD;
               defined by International Myeloma Working Group (IMWG) criteria and measurable disease&#xD;
               as defined by any of the following:&#xD;
  &#xD;
                 -  Serum M-protein &gt;= 1.0 g/dl&#xD;
  &#xD;
                 -  Urine monoclonal protein &gt;= 200 mg/24h&#xD;
  &#xD;
                 -  Involved free light chain (FLC) level &gt;= 10mg/dl (&gt;= 100mg/l) and an abnormal&#xD;
                    serum free light chain ratio (&lt; 0.26, or &gt; 1.65)&#xD;
  &#xD;
            -  Patients must have had at least 2 prior lines of therapy including lenalidomide,&#xD;
               proteasome inhibitor (PI), anti-CD38 directed antibody, and BCMA-targeted therapy&#xD;
  &#xD;
                 -  Prior elotuzumab is permitted but patients with progressive disease (PD) on&#xD;
                    elotuzumab are excluded; at least 6 months must have lapsed from prior elotuzumab&#xD;
                    exposure&#xD;
  &#xD;
            -  Patients must have hemoglobin &gt;= 7g/dL&#xD;
  &#xD;
            -  Absolute neutrophil count (ANC) &gt;= 1000/uL&#xD;
  &#xD;
            -  Platelets &gt;= 70,000/uL&#xD;
  &#xD;
                 -  If plasma cell percentage on bone marrow biopsy aspirate or core is &gt; 30%,&#xD;
                    platelet requirement will be adjusted to 50,000/ul&#xD;
  &#xD;
            -  Total bilirubin =&lt; 1.5 x the upper limit of normal (ULN)&#xD;
  &#xD;
            -  Aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/alkaline phosphatase &lt;&#xD;
               2.5 x the ULN&#xD;
  &#xD;
            -  Calculated creatinine clearance of &gt;= 45ml/min using Modification of Diet in Renal&#xD;
               Disease (MDRD) formula&#xD;
  &#xD;
            -  Left ventricular ejection fraction &gt;= 30%; baseline echocardiography (ECHO) is not&#xD;
               required if ECHO was done within the preceding one year and patients do not have new&#xD;
               signs/symptoms suggestive of heart failure&#xD;
  &#xD;
            -  No uncontrolled arrhythmias&#xD;
  &#xD;
            -  No New York Heart Association class III-IV heart failure&#xD;
  &#xD;
            -  12-lead electrocardiogram (ECG) with QT interval calculated by Fridericia formula&#xD;
               (QTcF) interval of =&lt; 470 msec&#xD;
  &#xD;
            -  Patient must be able to swallow capsule or tablet&#xD;
  &#xD;
            -  Patients must provide informed consent&#xD;
  &#xD;
            -  Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status&#xD;
               (PS) score of &lt; 2&#xD;
  &#xD;
            -  Women of child bearing potential (WOCBP) must commit to either abstain continuously&#xD;
               from heterosexual sexual intercourse or to use 2 methods of reliable birth control&#xD;
               simultaneously. This includes one highly effective form of contraception (tubal&#xD;
               ligation, intrauterine device [IUD], hormonal [birth control pills, injections,&#xD;
               hormonal patches, vaginal rings or implants] or partner's vasectomy) and one&#xD;
               additional effective contraceptive method (male latex or synthetic condom, diaphragm,&#xD;
               or cervical cap). Contraception must begin 4 weeks prior to dosing and continue to 6&#xD;
               months after study treatment ending. Reliable contraception is indicated even where&#xD;
               there has been a history of infertility, unless due to hysterectomy&#xD;
  &#xD;
            -  Investigators shall counsel WOCBP and male participants who are sexually active with&#xD;
               WOCBP on the importance of pregnancy prevention and the implications of an unexpected&#xD;
               pregnancy&#xD;
  &#xD;
            -  A negative pregnancy test will be required for all WOCBP within 24 hours before&#xD;
               starting treatment drugs&#xD;
  &#xD;
            -  Breast feeding is not permitted&#xD;
  &#xD;
            -  Male patients must agree to use an adequate method of contraception (latex or&#xD;
               synthetic condom) for the duration of the study and up to 6 months after study&#xD;
               treatment ending&#xD;
  &#xD;
            -  Criteria also applies to azoospermic males&#xD;
  &#xD;
            -  Males should refrain from sperm donation during this time and continue for 6 months&#xD;
               after study treatment ending&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with Waldenstrom macroglobulinemia, primary amyloid light chain (AL)&#xD;
               amyloidosis, primary plasma cell leukemia, or polyneuropathy, organomegaly,&#xD;
               endocrinopathy, monoclonal plasma cell disorder, skin changes (POEMS) syndrome&#xD;
  &#xD;
                 -  Patients with secondary plasma cell leukemia are permitted&#xD;
  &#xD;
            -  Patients with peripheral neuropathy &gt; National Cancer Institute (NCI) Common&#xD;
               Terminology Criteria for Adverse Events (CTCAE) grade 2, or grade 2 peripheral&#xD;
               neuropathy with pain&#xD;
  &#xD;
            -  Patients receiving concurrent corticosteroids at the time protocol therapy is&#xD;
               initiated other than for physiologic maintenance treatment&#xD;
  &#xD;
            -  Concurrent use of complementary or alternative medicines that would confound the&#xD;
               interpretation of toxicities and antitumor activity of the study drugs&#xD;
  &#xD;
            -  Patients with history of anaphylaxis or hypersensitivity to elotuzumab, lenalidomide,&#xD;
               or pomalidomide&#xD;
  &#xD;
            -  Concurrent use of strong CYP3A modulators; concurrent use of proton-pump inhibitors =&lt;&#xD;
               2 weeks prior to started CC-92480&#xD;
  &#xD;
            -  Unacceptable respiratory risk factors defined by any one of the following criteria:&#xD;
  &#xD;
                 -  Chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1&#xD;
                    second (FEV1) less than 50% of predicted normal&#xD;
  &#xD;
                 -  Moderate or severe persistent asthma within the past 2 years, or currently has&#xD;
                    uncontrolled asthma of any classification&#xD;
  &#xD;
            -  Unacceptable cardiac risk factors defined by any of the following criteria:&#xD;
  &#xD;
                 -  Left ventricular ejection fraction &lt; 30%&#xD;
  &#xD;
                 -  Complete left bundle branch, bifascicular block or clinically significant&#xD;
                    abnormal electrocardiogram (EKG) finding at screening&#xD;
  &#xD;
                 -  A prolongation of QT interval on screening ECG as defined by repeated&#xD;
                    demonstration of a QTc interval &gt; 470 msec using Fridericia's QT correction&#xD;
                    formula; a family history of long QT syndrome&#xD;
  &#xD;
                 -  Myocardial infarction within 6 months&#xD;
  &#xD;
                 -  Unstable angina&#xD;
  &#xD;
            -  Patients who have received targeted or investigational agents within 2 weeks or within&#xD;
               5 half-lives of the agent and active metabolites (whichever is shorter) and who have&#xD;
               not recovered from side effects of those therapies&#xD;
  &#xD;
            -  Patients who have undergone major surgery =&lt; 2 weeks prior to starting study drug or&#xD;
               who have not recovered from the side-effects of surgery&#xD;
  &#xD;
            -  Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C;&#xD;
               baseline testing for HIV and hepatitis C is not required&#xD;
  &#xD;
            -  Patients with active hepatitis B (defined as hepatitis B surface antigen [HBsAg]+);&#xD;
               hepatitis b virus (HBV) screening is required prior to beginning therapy&#xD;
  &#xD;
                 -  Patients with prior hepatitis B vaccine are permitted (defined as HBsAg-,&#xD;
                    hepatitis B virus surface antibody [anti-HBs]+, hepatitis B virus core antibody&#xD;
                    [anti-HBc]-)&#xD;
  &#xD;
                 -  Non-active hepatitis B (HBsAg-, anti-HBs+, anti-HBc+) may only be enrolled&#xD;
                    following approval by the sponsor after consideration of risk of reactivation&#xD;
                    (additional screening and monitoring for hepatitis B and consultation with a&#xD;
                    liver disease specialist may be required)&#xD;
  &#xD;
            -  Patients with a history of another primary malignancy that is currently clinically&#xD;
               significant or currently requires active intervention, other than non-melanoma skin&#xD;
               cancer and carcinoma in situ of the cervix or breast, should not be enrolled&#xD;
  &#xD;
            -  Patients with a history of gastrointestinal surgery or other procedure that might, in&#xD;
               the opinion of the investigator(s), interfere with the absorption or swallowing of the&#xD;
               study drugs&#xD;
  &#xD;
            -  Patients with any significant history of non-compliance to medical regimens or&#xD;
               unwilling or unable to comply with the instructions given to them by the study staff&#xD;
  &#xD;
            -  Any other medical condition, including mental illness or substance abuse, deemed by&#xD;
               the investigator(s) to likely interfere with the patient's ability to sign informed&#xD;
               consent, cooperate and participate in the study, or interfere with the interpretation&#xD;
               of the results&#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>Abdullah M Khan, MBBS, MSc</last_name>
      <role>Principal Investigator</role>
      <affiliation>Ohio State University Comprehensive Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>The Ohio State Comprehensive Cancer Center</last_name>
      <phone>800-293-5066</phone>
      <email>OSUCCCClinicaltrials@osumc.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Ohio State University Comprehensive Cancer Center</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43210</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Abdullah M. Khan, MBBS, MSc</last_name>
        <phone>614-293-3196</phone>
        <email>Abdullah.Khan@osumc.edu</email>
      </contact>
      <investigator>
        <last_name>Abdullah M. Khan, MBBS, MSc</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://cancer.osu.edu</url>
      <description>The Jamesline</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 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>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Ohio State University Comprehensive Cancer Center</investigator_affiliation>
      <investigator_full_name>Abdullah Khan</investigator_full_name>
      <investigator_title>Principal Investigator</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>
    <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>Elotuzumab</mesh_term>
      <mesh_term>Ichthammol</mesh_term>
      <mesh_term>BB 1101</mesh_term>
    </intervention_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/NCT05981209
  org study id: OSU-22207
  secondary id: NCI-2023-05518
  nct id: NCT05981209
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  This phase Ib trial tests the safety, side effects, and best dose of CC-92480 in combination
        with elotuzumab and dexamethasone in treating patients with multiple myeloma that has come
        back after a period of improvement (relapsed) or that does not respond to treatment or has
        not responded to previous treatment (refractory). Multiple myeloma (MM) remains the second
        most common hematologic malignancy in the United States. A number of therapies have been
        approved for patients with MM, including CD38- and B-cell maturating antigen (BCMA)-targeted
        therapies (antibody and plasma cell treatments that help the body's immune system to kill
        cancer cells); however, patients will often relapse and become refractory to these therapies.
        Because of this, it is important to identify effective treatment options for patients
        progressing on anti-CD38 therapy and BCMA-directed therapies. Elotuzumab is a humanized IgG1
        monoclonal antibody, which is a type of protein that can bind to other target cells to
        prevent them from working the way they should or cause them to act differently. Elotuzumab
        works by targeting a protein called SLAMF7, which is present on myeloma cells, and makes it
        easier for the immune system to target the cancer. CC-92480 works by binding to a protein
        called CRBN that triggers the breakdown of proteins: Ikaros and Aiolos, leading to cell death
        in multiple myeloma cells. Dexamethasone is a synthetic adrenocortical steroid, or steroid
        normally naturally made by the adrenal gland in the brain which has been produced in a
        laboratory, that helps to regulate the amount of different chemicals and water that are being
        processed by the kidneys. It is also used in patients with myeloma to help treat their
        disease. The combination of CC-92480 with elotuzumab and dexamethasone may be a safe and
        effective treatment when given to patients with relapsed or recurrent MM.
  PRIMARY OBJECTIVE:
  
        I. To evaluate the safety and tolerability of elotuzumab, mezigdomide (CC-92480), and
        dexamethasone (E480d) in patients with relapsed/refractory multiple myeloma (RRMM) who have
        received >= 2 prior regimens including CD38- and BCMA-targeted therapies.
  
        SECONDARY OBJECTIVES:
  
        I. To evaluate the objective response rate (ORR) (per International Myeloma Working Group
        [IMWG] criteria) of E480d.
  
        II. Determine the time to response (TTR), the duration of response (DOR), progression free
        survival (PFS) at 1 year, and overall survival (OS) at 1 year.
  
        III. Check minimal residual disease (MRD) negativity rates by next generation sequencing in
        patients who are suspected of attaining a complete response (CR).
  
        IV. Correlative studies will include changes in lymphocyte subsets with therapy,
        immunophenotype of MM cells, and expression of CRBN, Ikaros, and Aiolos.
  
        V. Quality of life (QOL) will be assessed.
  
        OUTLINE: This is a dose-escalation study of CC-92480, followed by a dose-expansion study.
  
        Patients receive elotuzumab intravenously (IV) on days 1, 8, 15, and 22 of cycles 1 and 2 and
        then on day 1 of each subsequent cycle. Patients also receive CC-92480 orally (PO) on days
        1-21 of each cycle and dexamethasone IV or PO on days 1, 8, 15, and 22 of each cycle. Cycles
        repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients
        may undergo an echocardiography (ECHO) during screening and undergo magnetic resonance
        imaging (MRI), computed tomography (CT), or x-ray imaging during screening and on study as
        clinically indicated. Patients also undergo blood sample collection as well as bone marrow
        biopsy and aspiration during screening and on study.
  
        After completion of study treatment, patients are followed up at 30 and 60 days and then
        every 12 weeks for up to 2 years.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The recommended phase 2 dose of mezigdomide (CC-92480) in combination with elotuzumab and dexamethasone
  time frame: Up to 28 days (Cycle 1)
  description: The dose limiting toxicity (DLT) will be defined as one or more of the following toxicities considered to be at least possibly related to the study drug, occurring during cycle 1 of therapy. Furthermore, inability to take >= 75% of the planned CC-92480 doses, or receive cycle 2 day 1 doses due to a drug-related adverse event occurring in cycle 1 will be considered a DLT.
  measure: Incidence of adverse events
  time frame: Up to 2 years
  description: Adverse events and toxicities of the combination regimen will be summarized using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be assessed overall, as well as by dose level. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of severe (grade 3+) adverse events or toxicities will be described. Will also assess tolerability of the regimen through assessing the number of patients who required dose modifications and/or dose delays. In addition, will capture the proportion of patients who go off treatment due to adverse reactions. All patients who have received at least one dose of any of the study regimen will be evaluable for toxicity.
  measure: Objective response rate (ORR)
  time frame: At 1 year
  description: Defined as the total number of subjects whose best response is partial response (PR) or better divided by the number of patients. Primary evaluation of antitumor activity of study treatment will be assessed according to International Myeloma Working Group (IMWG) response criteria. ORR will be calculated as a proportion of patients achieved a response. ORR will be reported overall as well as by dose level, with 95% binomial exact confidence intervals (CIs). Comparison of ORR among patient subgroups will be conducted using Fisher exact test.
  measure: Time to progression (TTP)
  time frame: From start of treatment until objective tumor progression; with death as a competing risk, assessed at 1 year
  description: Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. For TTP, cumulative incidence rates will be calculated and compared using Gray's test accounting for competing risks.
  measure: Time to response (TTR)
  time frame: From start of treatment until measurement criteria are first met for PR, very good partial response (VGPR), or complete response (CR) (whichever status is recorded first), assessed at 1 year
  description: Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. For TTR, cumulative incidence rates will be calculated and compared using Gray's test accounting for competing risks
  measure: Duration of response (DOR)
  time frame: From the time measurement criteria are first met for partial response or better (whichever status is recorded first) until the first date of progressive disease or death, assessed at 1 year
  description: DOR will be computed for subjects whose best response is either PR, VGPR, or CR. Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. DOR will be analyzed using the Kaplan-Meier method. The probability of survival and median DOR will be calculated together with 95% CIs, and log-rank test will be used for the comparison between patient subgroups.
  measure: Progression free survival (PFS)
  time frame: From start of treatment until disease progression or death, assessed at 1 year
  description: Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. PFS will be analyzed using the Kaplan-Meier method. The probability of survival and median PFS will be calculated together with 95% CIs, and log-rank test will be used for the comparison between patient subgroups.
  measure: Overall survival (OS)
  time frame: From start of treatment to the date of his or her death, assessed at 1 year
  description: Primary evaluation of antitumor activity of study treatment will be assessed according to IMWG response criteria. OS will be analyzed using the Kaplan-Meier method. The probability of survival and median OS will be calculated together with 95% CIs, and log-rank test will be used for the comparison between patient subgroups.
  measure: Minimal residual disease (MRD)
  time frame: At final study visit, up to 2 years
  description: Planned for patients suspected of attaining CR. MRD negativity is associated with superior outcomes compared to MRD positivity.
  measure: Changes in lymphocyte subsets with therapy
  time frame: Up to 2 years
  description: Changes in expression of these markers across time will be explored by dose level graphically. Relationships between changes in lymphocyte subsets, total number and ratio of regulatory T cells will be explored graphically (e.g. side-by-side boxplots) and with quantitative summaries, compared using Mann-Whitney test or Fisher exact test depending on the data type of expression data.
  measure: Changes in immunophenotype of multiple myeloma cells
  time frame: Up to 2 years
  description: Correlative studies including the changes in expression of these markers across time will be explored by dose level graphically.
  measure: Changes in expression of CRBN, Ikaros, and Aiolos with therapy
  time frame: Up to 2 years
  description: Changes in expression of these markers across time will be explored by dose level graphically.
  measure: Quality of life (QOL)
  time frame: At baseline and monthly until study completion, up to 2 years
  description: Measured with the Patient-Reported Outcomes Measurement Information System Global 10 Quality of Life Survey and The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma20. A repeated measures linear mixed model will be fit to all QOL scores. The model will include all time points (baseline as reference session 0 and 1-6 or higher for each monthly measure), and a patient-level random effect. A p-value for the difference between baseline QOL and QOL at the end of the study will be obtained from the model, and if the positive difference with p-value is < 0.05 QOL will be seen as improved.
  arm group label: Treatment (elotuzumab, CC-92480, dexamethasone)
  arm group type: Experimental
  description: Patients receive elotuzumab IV on days 1, 8, 15, and 22 of cycles 1 and 2 and then on day 1 of each subsequent cycle. Patients also receive CC-92480 PO on days 1-21 of each cycle and dexamethasone IV or PO on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may undergo an ECHO during screening and undergo MRI, CT, or x-ray imaging during screening and on study as clinically indicated. Patients also undergo blood sample collection as well as bone marrow biopsy and aspiration during screening and on study.
  intervention type: Procedure
  intervention name: Biospecimen Collection
  description: Undergo blood sample collection
  arm group label: Treatment (elotuzumab, CC-92480, dexamethasone)
  other name: Biological Sample Collection
  other name: Biospecimen Collected
  other name: Specimen Collection
  intervention type: Procedure
  intervention name: Bone Marrow Aspiration
  description: Undergo bone marrow biopsy and aspiration
  arm group label: Treatment (elotuzumab, CC-92480, dexamethasone)
  intervention type: Procedure
  intervention name: Bone Marrow Biopsy
  description: Undergo bone marrow biopsy and aspiration
  arm group label: Treatment (elotuzumab, CC-92480, dexamethasone)
  other name: Biopsy of Bone Marrow
  other name: Biopsy, Bone Marrow
  intervention type: Procedure
  intervention name: Computed Tomography
  description: Undergo CT
  arm group label: Treatment (elotuzumab, CC-92480, dexamethasone)
  other name: CAT
  other name: CAT Scan
  other name: Computed Axial Tomography
  other name: Computerized Axial Tomography
  other name: Computerized axial tomography (procedure)
  other name: Computerized Tomography
  other name: CT
  other name: CT Scan
  other name: tomography
  intervention type: Drug
  intervention name: Dexamethasone
  description: Given IV or PO
  arm group label: Treatment (elotuzumab, CC-92480, 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: Baycadron
  other name: Baycuten
  other name: Baycuten N
  other name: Cortidexason
  other name: Cortisumman
  other name: Decacort
  other name: Decadrol
  other name: Decadron
  other name: Decadron DP
  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: Dexamethasone Intensol
  other name: Dexamethasonum
  other name: Dexamonozon
  other name: Dexapos
  other name: Dexinoral
  other name: Dexone
  other name: Dinormon
  other name: Dxevo
  other name: Fluorodelta
  other name: Fortecortin
  other name: Gammacorten
  other name: Hemady
  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: TaperDex
  other name: Visumetazone
  other name: ZoDex
  intervention type: Procedure
  intervention name: Echocardiography
  description: Undergo ECHO
  arm group label: Treatment (elotuzumab, CC-92480, dexamethasone)
  other name: EC
  intervention type: Biological
  intervention name: Elotuzumab
  description: Given IV
  arm group label: Treatment (elotuzumab, CC-92480, dexamethasone)
  other name: BMS-901608
  other name: Empliciti
  other name: HuLuc-63
  other name: HuLuc63
  other name: PDL-063
  other name: PDL063
  intervention type: Procedure
  intervention name: Magnetic Resonance Imaging
  description: Undergo MRI
  arm group label: Treatment (elotuzumab, CC-92480, dexamethasone)
  other name: Magnetic Resonance
  other name: Magnetic resonance imaging (procedure)
  other name: Magnetic Resonance Imaging Scan
  other name: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  other name: MR
  other name: MR Imaging
  other name: MRI
  other name: MRI Scan
  other name: NMR Imaging
  other name: NMRI
  other name: Nuclear Magnetic Resonance Imaging
  intervention type: Biological
  intervention name: Mezigdomide
  description: Given PO
  arm group label: Treatment (elotuzumab, CC-92480, dexamethasone)
  other name: BMS 986348
  other name: BMS-986348
  other name: BMS986348
  other name: CC 92480
  other name: CC-92480
  other name: CELMoD CC-92480
  other name: Cereblon E3 Ligase Modulation Drug CC-92480
  other name: Cereblon E3 Ubiquitin Ligase Modulating Agent CC-92480
  other name: Cereblon Modulator CC-92480
  intervention type: Procedure
  intervention name: X-Ray Imaging
  description: Undergo x-ray imaging
  arm group label: Treatment (elotuzumab, CC-92480, dexamethasone)
  other name: Conventional X-Ray
  other name: Diagnostic Radiology
  other name: Medical Imaging, X-Ray
  other name: Plain film radiographs
  other name: Radiographic Imaging
  other name: Radiographic imaging procedure (procedure)
  other name: Radiography
  other name: RG
  other name: Static X-Ray
  other name: X-Ray
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Abdullah M Khan, MBBS, MSc
  role: Principal Investigator
  affiliation: Ohio State University Comprehensive Cancer Center
  last name: The Ohio State Comprehensive Cancer Center
  phone: 800-293-5066
  email: OSUCCCClinicaltrials@osumc.edu
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  url: http://cancer.osu.edu
  description: The Jamesline
  responsible party type: Sponsor-Investigator
  investigator affiliation: Ohio State University Comprehensive Cancer Center
  investigator full name: Abdullah Khan
  investigator title: Principal Investigator
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  mesh term: Dexamethasone
  mesh term: Dexamethasone acetate
  mesh term: Elotuzumab
  mesh term: Ichthammol
  mesh term: BB 1101
  sharing ipd: No