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ClinicalTrial.gov Identifier : NCT00742560

A Phase 1b/2, Dose-Escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Relapsed Multiple Myeloma

    Status Active, not recruiting
    Related Conditions

Enrollment Details

101 Worldwide Enrollment Goal

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type I and II phase trial.

Protocol ID
HuLuc63-1703

Brief summary

Top

A Phase 1b/2, Multicenter, Open-label, Dose-escalation Study of Elotuzumab (Humanized Anti CS1 Monoclonal IgG1 Antibody) in Combination with Lenalidomide and Dexamethasone in Subjects with Relapsed Multiple Myeloma.

Participant Attributes :
  • Male and Female
  • Ages 18 Years and older

Canada: 3

0
Calgary, AB
1
Toronto, ON
2
Halifax, NS
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Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
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    Allocation

    Non-Randomized

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
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    Endpoint Classification

    Safety/Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
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    Intervention Model

    Single Group Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
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    Masking

    Open Label

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
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    Purpose

    Treatment

    • Age 18 years or older with a confirmed diagnosis of MM and documentation of one to three prior therapies.
    • Confirmed evidence of disease progression from immediately prior MM therapy or refractory to the immediately prior treatment.
    • Measurable disease M protein component in serum (at least 0.5 g/dL) and/or urine (if present), (>=0.2 g excreted in a 24 hour collection sample). Subjects with free light chain only disease are excluded.
    • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2.
    • Creatinine clearance >=50 mL/min measured by Cockcroft-Gault method.
    • Hematologic parameters defined by:
    • Alanine aminotransferase (ALT) AND aspartate aminotransferase (AST) <3 × upper limit of normal.
    • Total bilirubin <2 × upper limit of normal, direct bilirubin <2.0 mg/dL.
    • Negative urine pregnancy test in women of childbearing potential at screening and prior to prescribing lenalidomide. Females of childbearing potential (FCBP) must either commit to continued abstinence from heterosexual intercourse or begin acceptable methods of birth control for 28 days prior to prescribing lenalidomide. Men must agree to use a latex condom during sexual contact with FCBP even if they have had a successful vasectomy, and must agree not to donate semen during study drug therapy and for a period of time after therapy.
    • Able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject's privacy regulations).
    • Able to take aspirin daily as prophylactic anticoagulation therapy (subjects intolerant to aspirin may use warfarin or low-molecular-weight heparin).
    • Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer from which the subject has been disease-free for at least 2 years.
    • Active or prior plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 10^9/L).
    • Uncontrolled medical problems such as diabetes mellitus, coronary artery disease, hypertension, unstable angina, arrhythmias, pulmonary disease, and symptomatic heart failure.
    • Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia.
    • Treatment with any investigational drug within 2 weeks or 3 half lives (whichever is longer) of the first dose of elotuzumab.
    • Use of corticosteroids, thalidomide, bortezomib, or cytotoxic chemotherapy within 2 weeks of the first dose of elotuzumab except for steroids with little or no systemic absorption (ie, topical or inhaled steroids).
    • Prior lenalidomide therapy.
    • Prior peripheral stem-cell transplant within 12 weeks of the first dose of elotuzumab.
    • Treatment with nitrosoureas, such as carmustine (BiCNU), nitrogen mustard agents, or melphalan, within 6 weeks of first dose of elotuzumab.
    • Neuropathy >=Grade 3 or painful neuropathy >=Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v3.0).
    • Known active infections requiring IV antibiotic, antiviral, or antifungal therapy.
    • Hypersensitivity to recombinant proteins or excipients in elotuzumab, lenalidomide, or dexamethasone.
    • Female subjects who are pregnant or breastfeeding.
    • Subjects with serum calcium (corrected for albumin) >= 12 mg/dL.

More on this trial

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