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A Study of Oral Ixazomib Maintenance Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation


Title A Phase 3, Randomized, Placebo-Controlled, Double-Blind Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Patients With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation
Therapeutic Area Multiple Myeloma
Principal Investigator Raymond Comenzo, MD
Min Age 18 Years
Gender both
Contact George Mensing
617-636-2683
More Information http://clinicaltrials.gov/ct2/show/NCT02312258

Overview

This study will assess whether taking ixazomib as maintenance therapy after standard treatments extends the period of time that a patient’s cancer stays inactive.

Maintenance therapy means that a drug is taken for a relatively long period (in this study, up to 24 months) to prolong the time that the myeloma remains under control after a prior therapy; in this study the prior therapy must not include autologous stem cell transplant.  It is not yet proven whether maintenance therapy given to people with multiple meyloma is better than waiting until the myeloma comes back to receive additional treatment.  The study will assess whether taking ixazomib immediately after responding to a prior therapy allows people with multiple myeloma to live longer by preventing or delaying the return of their disease.

This study is also being performed for these additional research purposes:

  • To evaluate the safety of ixazomib and to learn about the side effects associated with the use of this drug when it is used as a maintenance therapy.
  • To find out whether the presence of certain genes and proteins in the cancer cells of patients with multiple myeloma can predict whether ixazomib will work on cancers similar to yours.
  • To evaluate the health and overall well-being of patients while they are taking ixazomib.

    Study Details

    Inclusion Criteria

    • Previously received daratumumab or other anti-CD38 therapies
    • Prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of study start
    • Known chronic obstructive pulmonary disease, persistent asthma, or a history of asthma within 5 years

    Exclusion Criteria

    • No subjects with prior stem cell transplant
    • No subjects with complicating malignancies or diseases (including but not limited to: CNS involvement, diagnosis or treatment for other malignancies within 5 years, active serious infection, uncontrolled cardiovascular conditions, etc.)
    • No pregnant or nursing women

    Study Requirements

    To determine if they are eligible to be enrolled in the study, potential subjects will come to clinic for the following screening tests: medical history, physical exam, vitals, EKG, skeletal survey, blood tests, urine tests, and a bone marrow aspiration. Once enrolled, subjects will receive the study drug, a pill that can be swallowed, in cycles. Each cycle last 28 days. The study drug will be taken on day 1, day 8, and day 15 of each cycle. Subjects will come to clinic for physical exam, blood tests, and urine tests on day 1, day 8, and day 15 of cycle 1, day 1 and day 8 of cycle 2, and only on day 1 of each cycle thereafter. Subjects will also be asked to fill out questionnaires about how they are doing and how their disease affects their everyday life. Bone marrow aspirates will be taken at screening, at the time of complete response (if no complete response at screening), at cycle 13, and after stopping the study drug. After stopping the study drug, subjects will be followed either through continued clinic visits or phone calls to see how they are doing. Follow up will last up to 7 years.