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Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of The Pleiotropic Pathway Modifier CC-122 Administered Orally to Subjects With Advanced Solid Tumors, Non-Hodgkin's Lymphoma, or Multiple Myeloma

Clinical Trial Details

This is a clinical trial for men and women with relapse refractory multiple myeloma. The main purpose of this study is to test the safety of a new experimental drug called CC-122, a Pleiotropic Pathway Modulator (PPM). Pleiotropy refers to a case where one gene may influence several other characteristics or may have multiple effects in numerous tissues. This is the first study where CC-122 is being given to people. CC-122 is not approved yet by United States Food and Drug Administration (FDA) or any other health regulatory authority to treat cancer. CC-122 comes in the form of capsules that are taken by mouth and swallowed with water. CC-122 is made by Celgene Corporation, the study sponsor.

The study will look at the following information:

  • How long CC-122 stays in the body.
  • What effects, good and/or bad, CC-122 it has on the subject and cancer.
  • If there are biomarkers in the blood cells or tumor that can show if CC-122 is turning on the immune system, directly affecting the tumor or blocking the growth of blood vessels. Biomarkers are substances (such as proteins) that can be measured to find out if the study drug is working in the body. The testing for biomarkers in tumors requires the doctor to take biopsies if it is safe to do so.
    • In the “dose expansion” part of the study (explained below), the tumor biopsy is a required unless the tumor is not easily reached.
    • In the “dose escalation” the biopsy will be optional.
    • If the genetic and chemical make-up of the blood cells or tumor play a role in how a subject responds or does not respond to CC-122. Testing the genetic material (also called DNA and RNA) in the blood or tumor cells is required to take part in this research study.
    • If the tumor type is multiple myeloma, CC-122 may be tested in combination with Dexamethasone for tolerability, safety, and efficacy.

    Part A of the study is full and only Part B is accruing subjects. Part B will include approximately 240 people. The goal of Part B is to test the highest, and/or the near-highest tolerated dose levels found in Part A in larger groups of patients. Additional goals in Part B are to test the safety and tolerability of higher doses of CC-122 than Part A and to compare different intermittent schedules (5 out of 7 days per week or 21 out of 28 days per month) and to compare the tolerability of these different doses and schedules. In addition, a new capsule, which possibly results in more drug getting into the body, will be assessed for safety and tolerability in Part B. Part B will take about 36 months to complete. At Weill Cornell, this study is only open to subjects with multiple myeloma.

    Key Eligibility: 
    • 18 years or older with confirmed relapsed and refractory multiple myeloma
    • At least 2 prior lines of therapy
    • Documented evidence of progressive disease within the last 60 days
    • No prior treatment with pomalidomide
    • Received at least 2 cycles of lenalidomide and a proteasome inhibitor

    Contact

    Sheetal Ramnath
    shr2026@med.cornell.edu

    Primary Investigator

    Ruben Niesvizky, M.D.

    Protocol ID(s)

    Weill Cornell Medicine IRB #:

    1604017174

    Status:

    Open to Enrollment

    Age Group

    Adult

    Sponsor

    Drug/Device

    Drug

    Study Type

    Phase