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An Expanded Access Program for Elotuzumab in Combination With Lenalidomide Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma Identifier: NCT02368301

What is an Expanded Access Program?
A process regulated by the Food and Drug Administration (FDA) that allows manufacturers to provide investigational new drugs to patients with serious diseases or conditions who cannot participate in a clinical trial.

What is the purpose of this study?
The objective of this expanded access program is to provide treatment with elotuzumab in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma at U.S. sites where licensed physicians determine clinical need.

Can I participate in this study?
You may be eligible for this study if you meet the following criteria:

Conditions: Multiple Myeloma
Age: Between 18 – 100 Years
Gender: Male or Female

  • Eligibility Criteria

    Inclusion Criteria:

    • Men and women 18 years and older
    • Active, relapsed or refractory multiple myeloma by IMWG (International myeloma Working Group) criteria as assessed by the treating physician and have received one prior line of multiple myeloma therapy
    • Prior lenalidomide exposure is permitted only if they fulfill all of the following:
      • i) Were not refractory to prior lenalidomide defined as no progression while receiving lenalidomide (induction dose) or within 60 days of last dose of lenalidomide. Patients progressing on lenalidomide maintenance dose are eligible for enrolment.
      • ii) Patient did not discontinue lenalidomide due to a Grade ≥ 3 related AE

    Exclusion Criteria:

    • Active plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 109/L).
    • All Adverse Events of any prior chemotherapy, surgery, or radiotherapy not resolved to NCI CTCAE (v. 3.0) Grade ≤ 2
    • Significant cardiac disease as determined by the treating physician including cardiac amyloidosis
    • HIV infection or active hepatitis A, B, or C
    • History of participation in elotuzumab studies CA204-004, CA204-006 or CA204-009
    • Inadequate recovery from prior surgery or prior myeloma therapy. If prior allogeneic stem cell transplant, history of moderate to severe chronic graft versus host disease (GvHD)
    • Any medical conditions that, in the attending physician’s opinion, would impose excessive risk to the patient
    • Certain abnormal physical or laboratory findings
    • Hypersensitivity to lenalidomide, dexamethasone, any excipients in the elotuzumab formulation, or recombinant protein
  • Locations

    United States, Florida
    • Cancer Specialists of North Florida
      • Jacksonville, Florida, United States, 32258
      • Contact: Mehdi Moezi, Site 0008 904-272-3139
    • Medical Associates of Brevard
      • Melbourne, Florida, United States, 32935
      • Contact: Sumeet Chandra, Site 0007 321-254-4776

    United States, Maryland

    • Center For Cancer and Blood Disorders
      • Bethesda, Maryland, United States, 20817
      • Contact: Ralph Boccia, Site 0002 301-571-0988

    United States, Missouri

    • St. Louis Cancer Care LLP
      • Bridgeton, Missouri, United States, 63044
      • Contact: Juan Cuevas, Site 0005 314-201-3312

    United States, Nebraska

    • Southeast Nebraska Cancer Center
      • Lincoln, Nebraska, United States, 68510
      • Contact: Steven Dunder, Site 0004 402-420-7000
    • Oncology Hematology West PC
      • Omaha, Nebraska, United States, 68114
      • Contact: Stefano Tarantolo, Site 0006 402-280-4364

    United States, North Carolina

    • Randolph Cancer Center
      • Asheboro, North Carolina, United States, 27203
      • Contact: James Granfortuna, Site 0021 336-832-1100
    • Cone Health Cancer Center
      • Burlington, North Carolina, United States, 27215
      • Contact: James Granfortuna, Site 0020 336-832-1100
    • Cone Health Cancer Center
      • Greensboro, North Carolina, United States, 27403
      • Contact: James Granfortuna, Site 0019 336-832-1100

    United States, Tennessee

    • University of Tennessee Medical Center
      • Knoxville, Tennessee, United States, 32258
      • Contact: Wahid Hanna, Site 0011 865-305-9171

    United States, Utah

    • Northern Utah Associates
      • Ogden, Utah, United States, 84403
      • Contact: Vincent Hansen, Site 0001 801-387-7166

    United States, Virginia

    • Virginia Cancer Institute
      • Richmond, Virginia, United States, 23230
      • Contact: Maurice Schwarz, Site 0003 804-288-7159

For Physicians:
Physicians must submit requests for access to elotuzumab through the treatment use protocol (CA204-143) for patients with relapsed or refractory multiple myeloma. The application form may be accessed through the following link