Study Evaluating the Safety and Tolerability of Weekly Dosing of Oral IXAZOMIB in Adult Patients With Relapsed and Refractory Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: Ixazomib citrate
Intervention description: Ixazomib citrate capsules
Intervention MeSH terms: Ixazomib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
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; Drug therapy

Summary:

      The primary objective of this study is to determine the safety profile, tolerability, and
      maximum tolerated dose of ixazomib citrate (MLN9708) when taken orally on a weekly dosing
      schedule by patients with relapsed and refractory multiple myeloma (RRMM). Secondary
      objectives include pharmacokinetics and response rates.
    

Eligibility criteria:

        Inclusion Criteria:

        Each patient must meet all of the following eligibility criteria to be enrolled in the
        study:

          -  Adult patients with multiple myeloma who have relapsed following at least 2 lines of
             therapy.

          -  Patients must have measurable disease.

          -  Appropriate functional status, including the recovery from the effects of prior
             antineoplastic therapy, and acceptable organ function as described in the protocol.

          -  Female patients who are post menopausal, surgically sterile, or agree to practice 2
             effective methods of contraception or abstain from heterosexual intercourse.

          -  Male patients who agree to practice effective barrier contraception or agree to
             abstain from heterosexual intercourse.

          -  Willing and able to give written informed consent.

          -  Suitable venous access for study-required blood sampling.

        Exclusion Criteria:

          -  Peripheral neuropathy that is greater or equal to Grade 2.

          -  Major surgery or, serious infections, or infections that required systemic antibiotic
             therapy within 14 days before the first dose of study drug.

          -  Life-threatening illness unrelated to cancer.

          -  Diarrhea that is greater than Grade 1 as outlined in the protocol

          -  Systemic antineoplastic or radiation therapy within 14 days or cytotoxic agents, or
             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 medications that are outlined in the protocol
             within 14 days of study treatment.

          -  Ongoing therapy with corticosteroids greater than 10mg of prednisone or its equivalent
             per day.

          -  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.

          -  Known human immunodeficiency virus (HIV) positive, hepatitis B surface
             antigen-positive status, or known or suspected active hepatitis C infection.

          -  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.