Study of Oral Ixazomib in Adult Participants With Relapsed and/or Refractory (RR) Multiple Myeloma
Condition: Relapsed and Refractory Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Ixazomib
Intervention description: Ixazomib capsules
Intervention MeSH terms: Ixazomib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed multiple myeloma; Refractory multiple myeloma; Ixazomib Proteasome inhibitor

Summary:

      This study will determine the safety profile, tolerability, and maximum tolerated dose (MTD)
      and disease response of Ixazomib administered orally in participants with relapsed and/or
      refractory multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

        Each participant must meet all of the following inclusion criteria to be enrolled in the
        study:

          -  Multiple myeloma diagnosed according to the standard criteria.

          -  Participants with multiple myeloma who have relapsed following at least 2 lines of
             therapy.

          -  Participants must have measurable disease.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

          -  Female participants who are post menopausal, surgically sterile, or agree to practice
             2 effective methods of contraception or abstain from heterosexual intercourse.

          -  Male participants who agree to practice effective barrier contraception or agree to
             abstain from heterosexual intercourse.

          -  Voluntary written consent.

          -  Suitable venous access for study-required blood sampling.

        Exclusion Criteria:

        Participants meeting any of the following exclusion criteria are not to be enrolled in the
        study:

          -  Peripheral neuropathy greater than or equal to (>=) Grade 2.

          -  Female participants who are lactating or have a positive serum pregnancy test during
             the screening period.

          -  Major surgery within 14 days before the first dose of study drug.

          -  Infection requiring systemic antibiotic therapy or other serious infection within 14
             days before the first dose of study treatment.

          -  Life-threatening illness unrelated to cancer.

          -  Diarrhea > Grade 1, based on the National Cancer Institute Common Terminology Criteria
             for Adverse Events (NCI CTCAE) categorization.

          -  Systemic antineoplastic or radiation therapy within 14 days of cytotoxic agents within
             21 days before the first dose of study treatment.

          -  Treatment with any investigational products within 21 days before the first dose of
             study treatment.

          -  Treatment with any investigational proteasome inhibitor.

          -  Systemic treatment with prohibited medication.

          -  Ongoing therapy with corticosteroids greater than 10mg of prednisone or its equivalent
             per day. Inhaled and topical steroids are permitted.

          -  Central nervous system involvement.

          -  Evidence of current uncontrolled cardiovascular conditions, including cardiac
             arrhythmias, congestive heart failure, angina, or myocardial infarction within the
             past 6 months.

          -  Corrected QT interval (QTc) > 470 milliseconds on a 12-lead electrocardiogram (ECG)
             obtained during the screening period.

          -  Known human immunodeficiency virus (HIV) positive, hepatitis B surface
             antigen-positive status, or known or suspected active hepatitis C infection.

          -  Any serious medical or psychiatric illness that could, in the investigator's opinion,
             potentially interfere with the completion of treatment according to the protocol.

          -  Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral
             absorption of tolerance of ixazomib including difficulty swallowing.