<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/NCT03795597</url>
  </required_header>
  <id_info>
    <org_study_id>209274</org_study_id>
    <nct_id>NCT03795597</nct_id>
  </id_info>
  <brief_title>Busulfan, Melphalan, Escalating Carfilzomib Conditioning Auto Stem Cell Transplantation for Multiple Myeloma (MM)</brief_title>
  <acronym>BuMelCarAuto</acronym>
  <official_title>Phase I/II Study Utilizing High Dose Busulfan and Melphalan With Escalating Carfilzomib as Conditioning in Autologous Peripheral Blood Stem Cell Transplantation for Patients With Multiple Myeloma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Loyola University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amgen</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Loyola University</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>
      In this protocol, the investigators hypothesize that the combination of intravenous busulfan&#xD;
      and melphalan with carfilzomib will be an effective preparative regimen with acceptable&#xD;
      toxicity for participants with multiple myeloma who are candidates for autologous stem cell&#xD;
      transplantation. To test this hypothesis, the investigators designed a phase I/II trial&#xD;
      combining IV busulfan 130 mg/m2 plus melphalan 140 mg combined with escalating doses of&#xD;
      carfilzomib ranging from 20 mg/m2 to 45 mg/m2. These results will be compared with the&#xD;
      center's historical controls of participants treated with melphalan, busulfan and bortezomib.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants enrolled in this study protocol will receive daily intravenous (IV) infusions of&#xD;
      carfilzomib for a total of 4 days (Day-9, -8 and Days -2, -1). The first two daily infusions&#xD;
      will be given at a fixed dose of 20 mg/m2 and the final two doses will be escalated from the&#xD;
      standard dose of 27 mg/m2 to 56 mg/m2 in a Phase I design, based on toxicity. The busulfan&#xD;
      will be administered for 2 days over 3 hours from D-7, -6, at 130 mg/m2 . This dose was found&#xD;
      to be safe and equivalent to the standard daily dose of 3.2 mg/kg. The 3rd and 4th daily&#xD;
      doses of IV Busulfan will be adjusted in order to yield a systemic plasma drug exposure&#xD;
      represented by a daily area under the plasma concentration versus time curve (AUC) of&#xD;
      approximately 5,000 millimoles-minute per dose (mM-min). These targeted plasma concentration&#xD;
      of IV busulfan will be based on pharmacokinetics studies performed during the first day of IV&#xD;
      busulfan. Melphalan will be given at a dose of 140 mg/m2 on Day -3. Each cohort will start&#xD;
      with a goal of accruing three patients to determine the dose limiting toxicity.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 22, 2019</start_date>
  <completion_date type="Anticipated">November 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Busulfan IV over 3 hours every 24 hours for a total of 4 doses from D-6 to D-3. First two daily infusions will be given at a fixed dose of 3.2 mg/kg over 3 hours from D-6 to D-5. The 3rd and 4th daily doses will be adjusted to an AUC of approximately 5,000 mMol-min per dose.&#xD;
Melphalan 140 mg/ m2 IV over 15-30 minutes for one dose on day -3.&#xD;
Carfilzomib administration will follow a Phase I dose escalation design.&#xD;
Each cohort will start with a goal of accruing three patients to determine the dose limiting toxicities.&#xD;
Once the Maximum Tolerated Dose is established an expansion cohort will be treated to include a total of 10 additional patients.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>36 participants evaluated for safety with treatment-related adverse events and grading by using CTCAE v4.0.</measure>
    <time_frame>3 years</time_frame>
    <description>To determine the maximal tolerated dose of carfilzomib when added to busulfan and melphalan as a preparative regimen for high dose therapy with autologous hematopoietic transplantation for patients with multiply myeloma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>36 participants evaluated for tolerability with treatment-related adverse events and grading by using CTCAE v4.0.</measure>
    <time_frame>3 years</time_frame>
    <description>To determine the maximal tolerated dose of carfilzomib when added to busulfan and melphalan as a preparative regimen for high dose therapy with autologous hematopoietic transplantation for patients with multiply myeloma.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>36 participants evaluated for response to treatment by testing blood for multiple myeloma levels.</measure>
    <time_frame>100 days</time_frame>
    <description>To evaluate complete, very good partial, partial and stable disease response rate for both clinical and biologic endpoints.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36 participants evaluated for progression by testing blood for multiple myeloma levels.</measure>
    <time_frame>3 years</time_frame>
    <description>Progression Free Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36 participants evaluated for overall survival by clinical visit or contact by phone.</measure>
    <time_frame>3 years</time_frame>
    <description>Overall Survival</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36 participants evaluated for absolute neutrophil count by testing white blood cells levels.</measure>
    <time_frame>100 days</time_frame>
    <description>Days to neutrophil engraftment: Absolute neutrophil count &gt; 500/microliter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36 participants evaluated for platelet engraftment by testing platelet count in blood cells.</measure>
    <time_frame>100 days</time_frame>
    <description>Days to platelet engraftment: platelet count &gt; 20,000/microliter untransfused</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36 participants evaluated by oral exam to assess mucositis events and grading levels by using CTCAE v4.0.</measure>
    <time_frame>100 days</time_frame>
    <description>Mucositis: CTCAE v 4.0 grade and severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36 participants evaluated by the liver to assess Veno-occlusive disease and grading levels by using CTCAE v4.0.</measure>
    <time_frame>100 days</time_frame>
    <description>Veno-occlusive disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36 participants evaluated by a physical exam to assess peripheral neuropathy and grading by using CTCAE v4.0.</measure>
    <time_frame>3 years</time_frame>
    <description>Peripheral neuropathy greater than or equal to CTCAE V 4.0 Grade 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36 participants evaluated for response to treatment by testing urine for multiple myeloma levels.</measure>
    <time_frame>100 days</time_frame>
    <description>To evaluate complete, very good partial, partial no stable disease response rate for both clinical and biologic endpoints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36 participants evaluated for progression by testing urine for multiple myeloma levels.</measure>
    <time_frame>3 years</time_frame>
    <description>Progression Free Survival</description>
  </secondary_outcome>
  <number_of_arms>5</number_of_arms>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Carfilzomib IV at dose: 20 mg/m2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants will receive Carfilzomib IV at dose: 20 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and Granulocyte-Colony stimulating factor (G-CSF) given daily until engraftment occurs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carfilzomib IV at dose: 27 mg/m2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants will receive Carfilzomib IV at dose: 27 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carfilzomib IV at dose: 36 mg/m2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants will receive Carfilzomib IV at dose: 36 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carfilzomib IV at dose: 45 mg/m2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants will receive Carfilzomib IV at dose: 45 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Carfilzomib IV at dose: 56 mg/m2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The participants will receive Carfilzomib IV at dose: 56 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carfilzomib</intervention_name>
    <description>Carfilzomib is an anti-cancer drug acting as a selective proteasome inhibitor that is used to treat Multiple Myeloma.</description>
    <arm_group_label>Carfilzomib IV at dose: 20 mg/m2</arm_group_label>
    <arm_group_label>Carfilzomib IV at dose: 27 mg/m2</arm_group_label>
    <arm_group_label>Carfilzomib IV at dose: 36 mg/m2</arm_group_label>
    <arm_group_label>Carfilzomib IV at dose: 45 mg/m2</arm_group_label>
    <arm_group_label>Carfilzomib IV at dose: 56 mg/m2</arm_group_label>
    <other_name>Kyprolis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Busulfan IV</intervention_name>
    <description>Busulfan is an anti-cancer drug acting as a bifunctional alkylating agent that is used to treat Multiple Myeloma.</description>
    <arm_group_label>Carfilzomib IV at dose: 20 mg/m2</arm_group_label>
    <arm_group_label>Carfilzomib IV at dose: 27 mg/m2</arm_group_label>
    <arm_group_label>Carfilzomib IV at dose: 36 mg/m2</arm_group_label>
    <arm_group_label>Carfilzomib IV at dose: 45 mg/m2</arm_group_label>
    <arm_group_label>Carfilzomib IV at dose: 56 mg/m2</arm_group_label>
    <other_name>Busulfex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Melphalan IV</intervention_name>
    <description>Melphalan is an anti-cancer drug acting as alkylating agent that is used to treat Multiple Myeloma.</description>
    <arm_group_label>Carfilzomib IV at dose: 20 mg/m2</arm_group_label>
    <arm_group_label>Carfilzomib IV at dose: 27 mg/m2</arm_group_label>
    <arm_group_label>Carfilzomib IV at dose: 36 mg/m2</arm_group_label>
    <arm_group_label>Carfilzomib IV at dose: 45 mg/m2</arm_group_label>
    <arm_group_label>Carfilzomib IV at dose: 56 mg/m2</arm_group_label>
    <other_name>Alkeran</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be greater than or equal to 18 years of age.&#xD;
&#xD;
          -  Participants must have been diagnosed with multiple myeloma in a first or subsequent&#xD;
             remission and have undergone a successful pre-transplant work up and are otherwise&#xD;
             eligible for an autotransplant with a busulfan/melphalan preparative regimen at Loyola&#xD;
             University Medical Center.&#xD;
&#xD;
          -  Participants may receive this preparative regimen if in first or subsequent remission.&#xD;
             Participants may enter if they have received a prior autologous stem cell transplant&#xD;
             and this therapy produced a remission that lasted greater than 18 months before&#xD;
             progression of disease. Participants who have undergone prior allogeneic&#xD;
             transplantation are excluded.&#xD;
&#xD;
          -  All participants must have responsive disease as defined by a Partial Response or&#xD;
             greater to most recent conventional regimen.&#xD;
&#xD;
          -  Participants receiving prior carfilzomib will be eligible for inclusion provided they&#xD;
             demonstrated responsive disease to this agent and either had a remission that lasted&#xD;
             greater than 6 months after its discontinuance, or if in remission after a carfilzomib&#xD;
             containing regimen administered to qualify for transplant.&#xD;
&#xD;
          -  Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status&#xD;
             (PS) less than or equal to 2.&#xD;
&#xD;
          -  Acceptable heart function test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must not have below normal kidney function.&#xD;
&#xD;
          -  Participants must not have below normal liver function.&#xD;
&#xD;
          -  Participants must not have active bacterial, fungal, or viral infection.&#xD;
&#xD;
          -  Participants must not have severe lung function.&#xD;
&#xD;
          -  Participants must not have Grade 2 or greater peripheral neuropathy.&#xD;
&#xD;
          -  Participants must not have uncontrolled hypertension.&#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>Patrick Stiff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Loyola University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Patrick Stiff, MD</last_name>
    <phone>708-327-3148</phone>
    <email>mailto:pstiff@lumc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mary Lee, RN</last_name>
    <phone>708-327-2241</phone>
    <email>mailto:mlee@luc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Patrick Stiff, MD</last_name>
      <phone>708-327-3148</phone>
      <email>pstiff@lumc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Mary Lee, RN</last_name>
      <phone>708-327-2241</phone>
      <email>mlee@luc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>October 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>April 23, 2021</last_update_submitted>
  <last_update_submitted_qc>April 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Loyola University</investigator_affiliation>
    <investigator_full_name>Patrick Stiff</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Multiple Myeloma</keyword>
  <keyword>Autologous</keyword>
  <keyword>Stem Cell Transplantation</keyword>
  <keyword>Bone Marrow Transplant</keyword>
  <keyword>Carfilzomib</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>Melphalan</mesh_term>
    <mesh_term>Busulfan</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03795597
org study id: 209274
nct id: NCT03795597
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
In this protocol, the investigators hypothesize that the combination of intravenous busulfan
      and melphalan with carfilzomib will be an effective preparative regimen with acceptable
      toxicity for participants with multiple myeloma who are candidates for autologous stem cell
      transplantation. To test this hypothesis, the investigators designed a phase I/II trial
      combining IV busulfan 130 mg/m2 plus melphalan 140 mg combined with escalating doses of
      carfilzomib ranging from 20 mg/m2 to 45 mg/m2. These results will be compared with the
      center's historical controls of participants treated with melphalan, busulfan and bortezomib.
Participants enrolled in this study protocol will receive daily intravenous (IV) infusions of
      carfilzomib for a total of 4 days (Day-9, -8 and Days -2, -1). The first two daily infusions
      will be given at a fixed dose of 20 mg/m2 and the final two doses will be escalated from the
      standard dose of 27 mg/m2 to 56 mg/m2 in a Phase I design, based on toxicity. The busulfan
      will be administered for 2 days over 3 hours from D-7, -6, at 130 mg/m2 . This dose was found
      to be safe and equivalent to the standard daily dose of 3.2 mg/kg. The 3rd and 4th daily
      doses of IV Busulfan will be adjusted in order to yield a systemic plasma drug exposure
      represented by a daily area under the plasma concentration versus time curve (AUC) of
      approximately 5,000 millimoles-minute per dose (mM-min). These targeted plasma concentration
      of IV busulfan will be based on pharmacokinetics studies performed during the first day of IV
      busulfan. Melphalan will be given at a dose of 140 mg/m2 on Day -3. Each cohort will start
      with a goal of accruing three patients to determine the dose limiting toxicity.
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Busulfan IV over 3 hours every 24 hours for a total of 4 doses from D-6 to D-3. First two daily infusions will be given at a fixed dose of 3.2 mg/kg over 3 hours from D-6 to D-5. The 3rd and 4th daily doses will be adjusted to an AUC of approximately 5,000 mMol-min per dose.
Melphalan 140 mg/ m2 IV over 15-30 minutes for one dose on day -3.
Carfilzomib administration will follow a Phase I dose escalation design.
Each cohort will start with a goal of accruing three patients to determine the dose limiting toxicities.
Once the Maximum Tolerated Dose is established an expansion cohort will be treated to include a total of 10 additional patients.
primary purpose: Treatment
masking: None (Open Label)
measure: 36 participants evaluated for safety with treatment-related adverse events and grading by using CTCAE v4.0.
time frame: 3 years
description: To determine the maximal tolerated dose of carfilzomib when added to busulfan and melphalan as a preparative regimen for high dose therapy with autologous hematopoietic transplantation for patients with multiply myeloma.
measure: 36 participants evaluated for tolerability with treatment-related adverse events and grading by using CTCAE v4.0.
time frame: 3 years
description: To determine the maximal tolerated dose of carfilzomib when added to busulfan and melphalan as a preparative regimen for high dose therapy with autologous hematopoietic transplantation for patients with multiply myeloma.
measure: 36 participants evaluated for response to treatment by testing blood for multiple myeloma levels.
time frame: 100 days
description: To evaluate complete, very good partial, partial and stable disease response rate for both clinical and biologic endpoints.
measure: 36 participants evaluated for progression by testing blood for multiple myeloma levels.
time frame: 3 years
description: Progression Free Survival
measure: 36 participants evaluated for overall survival by clinical visit or contact by phone.
time frame: 3 years
description: Overall Survival
measure: 36 participants evaluated for absolute neutrophil count by testing white blood cells levels.
time frame: 100 days
description: Days to neutrophil engraftment: Absolute neutrophil count > 500/microliter
measure: 36 participants evaluated for platelet engraftment by testing platelet count in blood cells.
time frame: 100 days
description: Days to platelet engraftment: platelet count > 20,000/microliter untransfused
measure: 36 participants evaluated by oral exam to assess mucositis events and grading levels by using CTCAE v4.0.
time frame: 100 days
description: Mucositis: CTCAE v 4.0 grade and severity
measure: 36 participants evaluated by the liver to assess Veno-occlusive disease and grading levels by using CTCAE v4.0.
time frame: 100 days
description: Veno-occlusive disease
measure: 36 participants evaluated by a physical exam to assess peripheral neuropathy and grading by using CTCAE v4.0.
time frame: 3 years
description: Peripheral neuropathy greater than or equal to CTCAE V 4.0 Grade 3
measure: 36 participants evaluated for response to treatment by testing urine for multiple myeloma levels.
time frame: 100 days
description: To evaluate complete, very good partial, partial no stable disease response rate for both clinical and biologic endpoints
measure: 36 participants evaluated for progression by testing urine for multiple myeloma levels.
time frame: 3 years
description: Progression Free Survival
arm group label: Carfilzomib IV at dose: 20 mg/m2
arm group type: Experimental
description: The participants will receive Carfilzomib IV at dose: 20 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and Granulocyte-Colony stimulating factor (G-CSF) given daily until engraftment occurs.
arm group label: Carfilzomib IV at dose: 27 mg/m2
arm group type: Experimental
description: The participants will receive Carfilzomib IV at dose: 27 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.
arm group label: Carfilzomib IV at dose: 36 mg/m2
arm group type: Experimental
description: The participants will receive Carfilzomib IV at dose: 36 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.
arm group label: Carfilzomib IV at dose: 45 mg/m2
arm group type: Experimental
description: The participants will receive Carfilzomib IV at dose: 45 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.
arm group label: Carfilzomib IV at dose: 56 mg/m2
arm group type: Experimental
description: The participants will receive Carfilzomib IV at dose: 56 mg/m2 on days -9 and -8 over 30 minutes. The participant will receive Busulfan IV over 3 hours every 24 hours for a total of 4 doses from Day -6 to Day -3 and Melphalan IV over 15-30 minutes for one dose on day -3.The participants will receive stem cell infusion on Day 0 and G-CSF given daily until engraftment occurs.
intervention type: Drug
intervention name: Carfilzomib
description: Carfilzomib is an anti-cancer drug acting as a selective proteasome inhibitor that is used to treat Multiple Myeloma.
arm group label: Carfilzomib IV at dose: 20 mg/m2
arm group label: Carfilzomib IV at dose: 27 mg/m2
arm group label: Carfilzomib IV at dose: 36 mg/m2
arm group label: Carfilzomib IV at dose: 45 mg/m2
arm group label: Carfilzomib IV at dose: 56 mg/m2
other name: Kyprolis
intervention type: Drug
intervention name: Busulfan IV
description: Busulfan is an anti-cancer drug acting as a bifunctional alkylating agent that is used to treat Multiple Myeloma.
arm group label: Carfilzomib IV at dose: 20 mg/m2
arm group label: Carfilzomib IV at dose: 27 mg/m2
arm group label: Carfilzomib IV at dose: 36 mg/m2
arm group label: Carfilzomib IV at dose: 45 mg/m2
arm group label: Carfilzomib IV at dose: 56 mg/m2
other name: Busulfex
intervention type: Drug
intervention name: Melphalan IV
description: Melphalan is an anti-cancer drug acting as alkylating agent that is used to treat Multiple Myeloma.
arm group label: Carfilzomib IV at dose: 20 mg/m2
arm group label: Carfilzomib IV at dose: 27 mg/m2
arm group label: Carfilzomib IV at dose: 36 mg/m2
arm group label: Carfilzomib IV at dose: 45 mg/m2
arm group label: Carfilzomib IV at dose: 56 mg/m2
other name: Alkeran
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick Stiff, MD
role: Principal Investigator
affiliation: Loyola University
last name: Patrick Stiff, MD
phone: 708-327-3148
email: mailto:pstiff@lumc.edu
last name: Mary Lee, RN
phone: 708-327-2241
email: mailto:mlee@luc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Loyola University
investigator full name: Patrick Stiff
investigator title: Principal Investigator
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Melphalan
mesh term: Busulfan
sharing ipd: No