Pharmacokinetics Study of Oral Ixazomib (MLN9708) in Relapsed/Refractory Multiple Myeloma and Advanced Solid Tumors Patients With Normal Renal Function or Severe Renal Impairment

Inclusion Criteria:

- Male or female patients 18 years or older

- Patients with multiple myeloma (MM) diagnosed according to standard criteria or
patients with a diagnosis of an advanced malignant solid tumor for which standard,
curative, or life prolonging treatment does not exist or is no longer effective.
Patients with multiple myeloma must have had at least 1 prior therapy

- Patients with relapsed/refractory multiple myeloma after at least 1 prior therapy

- A calculated creatinine clearance (CrCl) that meets entry criteria for enrollment (ie,
calculated CrCl either ≥ 90 or < 30 mL/min

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- Female patients who are post menopausal, surgically sterile, or agree to practice 2
effective methods of contraception through 90 days after the last dose of study drug
or agree to practice true abstinence

- Male patients who agree to practice effective barrier contraception through 90 after
the last dose of study drug or agree to practice true abstinence

- Voluntary written informed consent

- Suitable venous access

Exclusion Criteria:

- Female patients who are pregnant or lactating and breastfeeding

- Failure to have recovered from clinically significant effects of prior chemotherapy
(defined as toxicity greater than Grade 1 with the exception of alopecia)

- Major surgery or radiotherapy within 14 days before study drug administration

- Dexamethasone (or equivalent systemic steroid) higher than the physiologic dosing with
7 days before study drug administration

- Central nervous system involvement

- Infection requiring IV antibiotic therapy or other serious infection within 14 days
prior to first dose of study drug

- Diagnosis of Waldenstrom's macroglobulinemia, POEMS (polyneuropathy, organomegaly,
endocrinopathy, monoclonal gammopathy, and skin changes) syndrome, plasma cell
leukemia, myeloproliferative syndrome, or primary amyloidosis (with the exception of
patients in whom amyloidosis has been documented as a complication of MM, who will be
evaluated on a case-by-case basis for trial participation)

- Systemic treatment with strong and moderate inhibitors of CYP1A2, strong and moderate
inhibitors of CYP3A, or clinically significant CYP3A inducers or use of Ginkgo biloba
or St. John's wort within 14 days before the first dose of study drug

- Evidence of uncontrolled cardiovascular conditions

- Ongoing or active infection, or known human immunodeficiency virus (HIV) positive

- Comorbid systemic illness or psychiatric illness that could interfere with study
completion

- Known allergy to study medications

- Inability to swallow oral medication or condition that could interfere with oral
absorption or tolerance of treatment