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Trial record 1 of 1 for:    NCT03003728
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2015-10: Expanded Natural Killer Cells and Elotuzumab for High-Risk Myeloma Post- Autologous Stem Cell Transplant (ASCT)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2017 by University of Arkansas
Sponsor:
Collaborators:
Bristol-Myers Squibb
Altor Bioscience Corporation
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT03003728
First received: December 21, 2016
Last updated: April 18, 2017
Last verified: April 2017
  Purpose
This study will evaluate the ability of Expanded Natural Killer (ENK) cells to treat multiple myeloma when administered as part of a regimen consisting of Elotuzumab and a stem cell transplant. Natural killer cells are a special type of white blood cells that are already present in the body which have the ability to kill myeloma cells. In this study, natural killer cells will be collected and then treated in a laboratory to activate and 'expand' the number of cells to increase the dose and the anti-myeloma activity of the cells before they are transfused back into the subject. Elotuzumab is a protein drug approved by the United States Food and Drug Administration (FDA) for patients with previously treated multiple myeloma and works by activating natural killer cells already present in the body and targeting a protein called SLAMF7 which is present on both natural killer cells and myeloma cells. The investigators hope that administering Elotuzumab in combination with ENK cells will enhance the anti-myeloma activity of the ENK cells.

Condition Intervention Phase
Multiple Myeloma
Drug: Elotuzumab
Drug: Melphalan
Procedure: Autologous Stem Cell Transplant (ASCT)
Biological: Expanded Natural Killer (ENK) Cells
Drug: ALT-803
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 2015-10: A Phase II Pilot Study of Expanded Natural Killer Cells and Elotuzumab to Eradicate High-Risk Myeloma Post Autologous Stem Cell Transplant

Resource links provided by NLM:


Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Multiple Myeloma Response [ Time Frame: 98 days post-ENK infusion (100 days post-ASCT) ]
    Response will be measured according to International Myeloma Working Group (IMWG) Criteria


Secondary Outcome Measures:
  • Adverse Events [ Time Frame: within 98 days post-ENK infusion (100 days post-ASCT) ]
    Frequency and severity of treatment-related adverse events

  • Persistence of ENK cells by flow cytometry and/or cytometry by time of flight (CyTOF) [ Time Frame: within 98 days post-ENK infusion (100 days post-ASCT) ]

Estimated Enrollment: 10
Anticipated Study Start Date: April 2017
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study Treatment
Elotuzumab 10 mg/kg via intravenous infusion on days -16, -3, 12, and 26; Melphalan 200 mg/m2 Ivia intravenous infusion on day -3; ASCT on day -2; ENK infusion on day 0; ALT-803 (Interleukin-15 superagonist) 10 ug/kg via subcutaneous injection on days 1, 8, 15, and 22.
Drug: Elotuzumab
Elotuzumab 10 mg/kg via intravenous infusion on days -16, -3, 12, and 26
Other Name: Empliciti
Drug: Melphalan
Melphalan 200 mg/m2 Ivia intravenous infusion on day -3
Procedure: Autologous Stem Cell Transplant (ASCT)
ASCT on day -2
Biological: Expanded Natural Killer (ENK) Cells
ENK cell infusion on day 0
Drug: ALT-803
ALT-803 (Interleukin-15 superagonist) 10 ug/kg via subcutaneous injection on days 1, 8, 15, and 22
Other Name: IL-15 superagonist

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Multiple myeloma patients that have completed induction chemotherapy and peripheral blood stem cell collection (PBSC) in preparation for ASCT.
  • Patients must have high-risk disease as defined by Gene Expression Profiling (GEP) 70 risk score of ≥ 0.66 or GEP 80 gene score of ≥ 2.48 or metaphase cytogenetic abnormalities or lactate dehydrogenase (LDH) ≥ 360 U/L (Rule out hemolysis, infection and contact PI for clarification if any doubt).
  • Patients must have failed prior treatment for their multiple myeloma (MM) including a proteasome inhibitor and immunomodulatory drug (so-called 'double refractory'). Patients who have received prior salvage combination chemotherapy after failure of proteasome inhibitor and immunomodulatory drug are eligible (frank relapse at the time of enrollment is not required)
  • Zubrod ≤ 2, unless solely due to symptoms of MM-related (bone) disease.
  • Patients must have a platelet count of ≥ 20,000/μL within 30 days of enrollment, unless lower levels are explained by extensive bone marrow plasmacytosis or extensive prior therapy.
  • Patients must be at least 18 years of age and not older than 75 years of age at the time of registration.
  • must have preserved renal function as defined by a serum creatinine level of ≤ 3 mg/dL within 30 days of registration.
  • Participants must have an ejection fraction by echocardiogram (ECHO) or multi-gated acquisition (MUGA) scan ≥ 40% within 90 days prior to registration.
  • Patients must have adequate pulmonary function studies ≥ 50% of predicted on mechanical aspects and diffusion capacity (DLCO) ≥ 50% of predicted within 90 days prior to registration. If the patient is unable to complete pulmonary function tests due to MM-related pain or condition, exception may be granted if the principal investigator documents that the patient is a candidate for high-dose therapy.
  • Patients must have at least 2x106 CD34+ cells/kg stored for transplant. In addition, there will be a 'back-up' available of 2x106 CD34+ cells/kg2x106 CD34+ cells/kg
  • Patients must have signed an Institutional Review Board-approved informed consent and HIPAA authorization form.

Exclusion Criteria:

  • Prior allo-transplant.
  • Prior auto-transplantation is permitted provided the patient is still presently a transplant candidate and at least 2 months should have passed since last auto-transplant
  • History of poorly-controlled hypertension, diabetes mellitus, or any other serious medical illness or psychiatric illness that could potentially interfere with the completion of treatment according to this protocol or could be considered to be an exclusion criterion deemed by the PI.
  • Patients must not have prior malignancy, except for adequately-treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has not received treatment for one year prior to enrollment. Other cancers will only be acceptable if the patient's life expectancy exceeds three years as determined by the PI.
  • Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy test documented within one week of registration. Women/men of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
  • The subject may not be positive for HIV I/II or HTLV-I/II.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03003728

Contacts
Contact: Nathan Petty 501-526-6990 ext 2435 pettynathanm@uams.edu
Contact: David Avery daavery@uams.edu

Sponsors and Collaborators
University of Arkansas
Bristol-Myers Squibb
Altor Bioscience Corporation
Investigators
Principal Investigator: Frits van Rhee, MD, PhD University of Arkansas
  More Information

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT03003728     History of Changes
Other Study ID Numbers: 205992
Study First Received: December 21, 2016
Last Updated: April 18, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017