<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/NCT03269136</url>
  </required_header>
  <id_info>
    <org_study_id>C1071001</org_study_id>
    <secondary_id>2019-000822-24</secondary_id>
    <nct_id>NCT03269136</nct_id>
  </id_info>
  <brief_title>PF-06863135 As Single Agent And In Combination With Immunomodulatory Agents In Relapse/Refractory Multiple Myeloma</brief_title>
  <official_title>MAGNETISMM-1 A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH IMMUNOMODULATORY AGENTS IN PATIENTS WITH RELAPSED/REFRACTORY ADVANCED MULTIPLE MYELOMA (MM)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</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>
      To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients&#xD;
      with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose&#xD;
      and select the recommended Phase 2 dose.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety,&#xD;
      pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced&#xD;
      multiple myeloma who have relapsed from or are refractory to standard therapy. This is a two&#xD;
      part study; Part 1 will assess the safety and tolerability of increasing dose levels of&#xD;
      PF-06863135 and Part 2 will evaluate safety and anti-myeloma activity of PF-06863135 at the&#xD;
      RP2Ds determined in Part 1.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 29, 2017</start_date>
  <completion_date type="Anticipated">December 29, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 29, 2023</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose Escalation: Number of participants with Dose-limiting toxicities (DLT)</measure>
    <time_frame>At the end of Cycle 1 (each Cycle is 21 or 28 days)</time_frame>
    <description>Number of participants with DLTs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate anti-myeloma activity by objective response rate (ORR) in dose expansion</measure>
    <time_frame>From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)</time_frame>
    <description>Percentage of participants with Objective Response Rate (ORR) using the international myeloma working group (IMWG) response criteria for multiple myeloma</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate anti-myeloma activity by duration of response (DOR) in dose expansion</measure>
    <time_frame>From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)</time_frame>
    <description>Time from first assessment of partial response or better to last assessment of partial response or better by IMWG criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate incidence of treatment emergent adverse events and laboratory abnormalities</measure>
    <time_frame>From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)</time_frame>
    <description>Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate anti-myeloma activity by objective response rate (ORR) in dose escalation</measure>
    <time_frame>From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)</time_frame>
    <description>Percentage of participants with Objective Response Rate (ORR) using the international myeloma working group (IMWG) response criteria for multiple myeloma</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate anti-myeloma activity by time to event endpoints</measure>
    <time_frame>From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)</time_frame>
    <description>Time from start date to date of first documentation of event (response or progression by IMWG criteria or death)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate anti-myeloma activity by duration of event endpoints</measure>
    <time_frame>From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)</time_frame>
    <description>Time from first assessment of event endpoint (response or stable disease) to last assessment of (response or stable disease) by IMWG criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of treatment on systemic soluble immune factors</measure>
    <time_frame>9 months on treatment</time_frame>
    <description>Pre and post dose quantification of soluble cytokines in serum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum plasma concentration (Cmax) of PF-06863135</measure>
    <time_frame>Cycle 1 Day 1 and Cycle 2 Day 1 (3 to 4 weeks)</time_frame>
    <description>Peak concentration of PF-06863135 during first cycle</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Trough serum concentrations of PF-06863135 and dexamethasone</measure>
    <time_frame>From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)</time_frame>
    <description>Trough serum concentrations of PF-06863135 and dexamethasone at selected cycles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135</measure>
    <time_frame>From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)</time_frame>
    <description>AUC of PF-06863135 will be calculated at selected cycles</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and titers of anti-drug antibodies and neutralizing antibodies against PF-06863135</measure>
    <time_frame>From baseline and scheduled timepoints post dose through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)</time_frame>
    <description>Number of participants with the presence of anti-PF-06863135 antibodies</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>PF-06863135</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BCMA-CD3 bispecific antibody</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06863135 + dexamethasone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BCMA-CD3 bispecific antibody + dexamethasone</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06863135 + lenalidomide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BCMA-CD3 bispecific antibody + lenalidomide</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PF-06863135 + pomalidomide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>BCMA-CD3 bispecific antibody + pomalidomide</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06863135 monotherapy IV or SC</intervention_name>
    <description>PF-06863135 will be administered intravenously or subcutaneously.</description>
    <arm_group_label>PF-06863135</arm_group_label>
    <other_name>BCMA-CD3 bispecific antibody</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06863135 + dexamethasone</intervention_name>
    <description>PF-06863135 will be administered intravenously or subcutaneously and dexamethasone orally.</description>
    <arm_group_label>PF-06863135 + dexamethasone</arm_group_label>
    <other_name>BCMA-CD3 bispecific antibody + dexamethasone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06863135 + lenalidomide</intervention_name>
    <description>PF-06863135 will be administered intravenously or subcutaneously and lenalidomide orally</description>
    <arm_group_label>PF-06863135 + lenalidomide</arm_group_label>
    <other_name>BCMA-CD3 bispecific antibody + lenalidomide</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PF-06863135 + pomalidomide</intervention_name>
    <description>PF-06863135 will be administered intravenously or subcutaneously and pomalidomide orally</description>
    <arm_group_label>PF-06863135 + pomalidomide</arm_group_label>
    <other_name>BCMA-CD3 bispecific antibody + pomalidomide</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Relapsed/refractory multiple myeloma&#xD;
&#xD;
          -  Progressed or are intolerant of established therapies including proteasome inhibitor,&#xD;
             immunomodulatory drug, and anti-CD38 antibody&#xD;
&#xD;
          -  Performance Status of 0- 1 ( Performance Score 2 is permitted only if due to&#xD;
             underlying myeloma)&#xD;
&#xD;
          -  Adequate bone marrow, hematological, kidney and liver function&#xD;
&#xD;
          -  Resolved acute effects of any prior therapy to baseline severity&#xD;
&#xD;
          -  Not pregnant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recent history of other malignancies&#xD;
&#xD;
          -  History of active autoimmune disorders&#xD;
&#xD;
          -  Any form of primary immunodeficiency&#xD;
&#xD;
          -  Active and clinically significant bacterial, fungal, or viral infection&#xD;
&#xD;
          -  Evidence of active mucosal or internal bleeding&#xD;
&#xD;
          -  History of severe immune-mediated adverse event with prior immunomodulatory treatment&#xD;
&#xD;
          -  Major surgery within 4 weeks of study treatment start&#xD;
&#xD;
          -  Radiation therapy within 2 weeks of study treatment start&#xD;
&#xD;
          -  History of stem cell transplant (autologous or allogeneic) within 100 days prior to&#xD;
             study enrollment&#xD;
&#xD;
          -  Donor Lymphocyte Infusion (DLI) within 30 days prior to study entry&#xD;
&#xD;
          -  Less than 30 days since last dose of antibody based therapies or less than 5&#xD;
             half-lives since last dose of previous therapy&#xD;
&#xD;
          -  Requirement for systemic immune suppressive medication except as permitted in the&#xD;
             protocol&#xD;
&#xD;
          -  Current requirement for chronic blood product support&#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>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSD Medical Center - Encinitas</name>
      <address>
        <city>Encinitas</city>
        <state>California</state>
        <zip>92024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Hospital)</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC San Diego Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UC San Diego Medical Center - Hillcrest</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCSD Medical Center - Vista</name>
      <address>
        <city>Vista</city>
        <state>California</state>
        <zip>92081</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Blood and Marrow Transplant Group of Georgia</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northside Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30342</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UChicago Medicine - River East</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UChicago Medicine at Ingalls - Flossmoor</name>
      <address>
        <city>Flossmoor</city>
        <state>Illinois</state>
        <zip>60422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UChicago Medicine Ingalls Memorial</name>
      <address>
        <city>Harvey</city>
        <state>Illinois</state>
        <zip>60426</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Comprehensive Cancer Center at Silver Cross Hospital</name>
      <address>
        <city>New Lenox</city>
        <state>Illinois</state>
        <zip>60451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Chicago Medicine Center for Advanced Care Orland Park</name>
      <address>
        <city>Orland Park</city>
        <state>Illinois</state>
        <zip>60462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UChicago Medicine at Ingalls - Tinley Park</name>
      <address>
        <city>Tinley Park</city>
        <state>Illinois</state>
        <zip>60477</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Clinic Foundation</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center at Basking Ridge</name>
      <address>
        <city>Basking Ridge</city>
        <state>New Jersey</state>
        <zip>07920</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center at Monmouth</name>
      <address>
        <city>Middletown</city>
        <state>New Jersey</state>
        <zip>07748</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center at Bergen</name>
      <address>
        <city>Montvale</city>
        <state>New Jersey</state>
        <zip>07645</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center at Commack</name>
      <address>
        <city>Commack</city>
        <state>New York</state>
        <zip>11725</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center at Westchester</name>
      <address>
        <city>Harrison</city>
        <state>New York</state>
        <zip>10604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center at Nassau</name>
      <address>
        <city>Uniondale</city>
        <state>New York</state>
        <zip>11553</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Health System: Adult Bone Marrow Transplant Clinic</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Cancer Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Hospital</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Joyce Cancer Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Investigational Drug Services, Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Unit 57, Special Services Building</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tom Baker Cancer Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 4N2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health Network - Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health center</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MUHC, GLEN site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Greece</country>
  </removed_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=C1071001</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 28, 2023</last_update_submitted>
  <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>relapse/ refractory multiple myeloma</keyword>
  <keyword>bispecific antibody</keyword>
  <keyword>bispecific</keyword>
  <keyword>BCMA</keyword>
  <keyword>BCMA- CD3 bispecific</keyword>
  <keyword>Phase 1</keyword>
  <keyword>PF-06863135</keyword>
  <keyword>dexamethasone</keyword>
  <keyword>lenalidomide</keyword>
  <keyword>pomalidomide</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thalidomide</mesh_term>
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>Lenalidomide</mesh_term>
    <mesh_term>Pomalidomide</mesh_term>
    <mesh_term>Antibodies</mesh_term>
    <mesh_term>Immunoglobulins</mesh_term>
    <mesh_term>Antibodies, Bispecific</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
  </patient_data>
  <!-- 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/NCT03269136
org study id: C1071001
secondary id: 2019-000822-24
nct id: NCT03269136
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To assess the safety and tolerability at increasing dose levels of PF-06863135 in patients
      with relapse/ refractory multiple myeloma in order to determine the maximum tolerated dose
      and select the recommended Phase 2 dose.
Study C1071001 is a Phase 1, open label, multi dose, multi center, dose escalation, safety,
      pharmacokinetic (PK) and pharmacodynamic study of PF-06863135 in adult patients with advanced
      multiple myeloma who have relapsed from or are refractory to standard therapy. This is a two
      part study; Part 1 will assess the safety and tolerability of increasing dose levels of
      PF-06863135 and Part 2 will evaluate safety and anti-myeloma activity of PF-06863135 at the
      RP2Ds determined in Part 1.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose Escalation: Number of participants with Dose-limiting toxicities (DLT)
time frame: At the end of Cycle 1 (each Cycle is 21 or 28 days)
description: Number of participants with DLTs
measure: To evaluate anti-myeloma activity by objective response rate (ORR) in dose expansion
time frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
description: Percentage of participants with Objective Response Rate (ORR) using the international myeloma working group (IMWG) response criteria for multiple myeloma
measure: To evaluate anti-myeloma activity by duration of response (DOR) in dose expansion
time frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
description: Time from first assessment of partial response or better to last assessment of partial response or better by IMWG criteria
measure: To evaluate incidence of treatment emergent adverse events and laboratory abnormalities
time frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
description: Type, incidence, severity, timing, seriousness and relationship to study treatment of adverse events and any laboratory abnormalities
measure: To evaluate anti-myeloma activity by objective response rate (ORR) in dose escalation
time frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
description: Percentage of participants with Objective Response Rate (ORR) using the international myeloma working group (IMWG) response criteria for multiple myeloma
measure: To evaluate anti-myeloma activity by time to event endpoints
time frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
description: Time from start date to date of first documentation of event (response or progression by IMWG criteria or death)
measure: To evaluate anti-myeloma activity by duration of event endpoints
time frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
description: Time from first assessment of event endpoint (response or stable disease) to last assessment of (response or stable disease) by IMWG criteria
measure: Impact of treatment on systemic soluble immune factors
time frame: 9 months on treatment
description: Pre and post dose quantification of soluble cytokines in serum.
measure: Maximum plasma concentration (Cmax) of PF-06863135
time frame: Cycle 1 Day 1 and Cycle 2 Day 1 (3 to 4 weeks)
description: Peak concentration of PF-06863135 during first cycle
measure: Trough serum concentrations of PF-06863135 and dexamethasone
time frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
description: Trough serum concentrations of PF-06863135 and dexamethasone at selected cycles
measure: Area under the concentration versus time curve from time zero to the last quantifiable time point prior to the next dose (AUClast) of PF-06863135
time frame: From baseline through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
description: AUC of PF-06863135 will be calculated at selected cycles
measure: Incidence and titers of anti-drug antibodies and neutralizing antibodies against PF-06863135
time frame: From baseline and scheduled timepoints post dose through disease progression, patient refusal, unacceptable toxicity or study completion (approximately 2 years)
description: Number of participants with the presence of anti-PF-06863135 antibodies
arm group label: PF-06863135
arm group type: Experimental
description: BCMA-CD3 bispecific antibody
arm group label: PF-06863135 + dexamethasone
arm group type: Experimental
description: BCMA-CD3 bispecific antibody + dexamethasone
arm group label: PF-06863135 + lenalidomide
arm group type: Experimental
description: BCMA-CD3 bispecific antibody + lenalidomide
arm group label: PF-06863135 + pomalidomide
arm group type: Experimental
description: BCMA-CD3 bispecific antibody + pomalidomide
intervention type: Drug
intervention name: PF-06863135 monotherapy IV or SC
description: PF-06863135 will be administered intravenously or subcutaneously.
arm group label: PF-06863135
other name: BCMA-CD3 bispecific antibody
intervention type: Drug
intervention name: PF-06863135 + dexamethasone
description: PF-06863135 will be administered intravenously or subcutaneously and dexamethasone orally.
arm group label: PF-06863135 + dexamethasone
other name: BCMA-CD3 bispecific antibody + dexamethasone
intervention type: Drug
intervention name: PF-06863135 + lenalidomide
description: PF-06863135 will be administered intravenously or subcutaneously and lenalidomide orally
arm group label: PF-06863135 + lenalidomide
other name: BCMA-CD3 bispecific antibody + lenalidomide
intervention type: Drug
intervention name: PF-06863135 + pomalidomide
description: PF-06863135 will be administered intravenously or subcutaneously and pomalidomide orally
arm group label: PF-06863135 + pomalidomide
other name: BCMA-CD3 bispecific antibody + pomalidomide
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
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country: Canada
country: United States
country: Greece
url: https://pmiform.com/clinical-trial-info-request?StudyID=C1071001
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Thalidomide
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: Lenalidomide
mesh term: Pomalidomide
mesh term: Antibodies
mesh term: Immunoglobulins
mesh term: Antibodies, Bispecific
mesh term: BB 1101
sharing ipd: No
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.