Intervention: Ixazomib
Trial phase: Phase 1
ATC code: L01XG03
SMILES: CC(C)C[C@H](NC(=O)CNC(=O)c1cc(Cl)ccc1Cl)B(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Ixazomib 3.0 mg, capsules, orally once on Day 1 of part A of 15 days followed by ixazomib 4 mg, capsules, orally on Days 1, 8, and 15 of each 28-day cycle in end-stage renal disease participants until disease progression or unacceptable toxicity in part B.

Dose modification of 3 or 2.3 mg was administered per protocol dose modification guidelines.
Eligibility criteria:
Inclusion Criteria:

Male or female participants 18 years or older
Participants with multiple myeloma (MM) diagnosed according to standard criteria or participants 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. Participants with multiple myeloma must have had at least 1 prior therapy
A calculated creatinine clearance (CrCl) that meets entry criteria for enrollment (i.e., calculated CrCl either ≥ 90 mL/min for normal renal function or < 30 mL/min for severe renal impairment)
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
Female participants 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 participants 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 participants 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 physiologic dosing within 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 Cytochrome P1A2 (CYP1A2), strong and moderate inhibitors of Cytochrome P3A (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