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

Time frame: Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dose

Population: PK evaluable population was defined as participants who received protocol-specified single dose in Part A; did not receive any excluded concomitant medications through the completion of PK sampling; and had sufficient concentration-time data to permit reliable estimation of PK parameters by non-compartmental analysis methods.

Time frame: Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dose

Population: PK evaluable population was defined as participants who received protocol-specified single dose in Part A; did not receive any excluded concomitant medications through the completion of PK sampling; and had sufficient concentration-time data to permit reliable estimation of PK parameters by non-compartmental analysis methods.

Time frame: Part A, Day 1: Predose and at multiple timepoints (up to 336 hours) post-dose

Population: Pharmacokinetic (PK) evaluable population was defined as participants who received protocol-specified single dose in Part A; did not receive any excluded concomitant medications through the completion of PK sampling; and had sufficient concentration-time data to permit reliable estimation of PK parameters by non-compartmental analysis methods.

DOR was defined as time from date of first documentation of a PR or better to date of first documentation of progressive disease (PD) for responders. Increase of \>25% from lowest response value in any one or more of following: Serum M-component and/or (absolute increase must be \>0.5 g/dL); Urine M-component and/or (the absolute increase must be \>200 mg/24 h); difference between involved and uninvolved free light chain (FLC) levels and the absolute increase must be \> 10 mg/dL; Bone marrow plasma cell percentage; absolute percentage must be \> 5%; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcaemia (corrected serum calcium \> 11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Responders without PD were censored at the date of the last response assessment that was stable disease (SD) or better.

Time frame: Day 1 of every other cycle from cycle 1 (each cycle of 28 days) up to progression of disease (approximately up to 855 days)

Population: Response evaluable population is defined as participants who received at least 1 cycle of Ixazomib treatment in Part B and at least 1 post-baseline response assessment. Here, number of participants analyzed is the participants who had confirmed response.

Adverse Event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Time frame: From signing of first dose of study drug up to the 30 days after the last dose of study drug (approximately up to 885 days)

Population: Safety population is defined as participants who received at least 1 dose of study drug.

Overall response rate defined as percentage of relapsed/refractory multiple myeloma participants who achieved partial response (PR), complete response (CR) and very good partial response (VGPR) according to International Myeloma Working Group Criteria. PR=\>50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or \<200 mg/24 h. If serum and urine M-protein are unmeasurable, \>50% decrease in difference between involved and uninvolved free light chain levels in place of M-protein criteria. If serum and urine M-protein and serum free light assay are not measurable, \>50% reduction in plasma cells in place of M-protein, provided baseline bone marrow plasma cell \>0%; CR=negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow; VGPR=serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \<100 mg/24 h.

Time frame: Day 1 of every other cycle from cycle 1 (each cycle of 28 days) up to progression of disease (approximately up to 855 days)

Population: Response evaluable is defined as participants who received at least 1 cycle of ixazomib treatment in Part B and at least 1 post-baseline response assessment.