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

About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Drug Therapy
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
Sites / Locations
- Winship Cancer Institute, Emory University
- Illinois Cancer Care
- University of Kansas Cancer Center, Clinical Research Center
- University of Maryland
- Mount Sinai Medical Center
- University of Oklahoma Peggy and Charles Stephenson Cancer Center
- Sarah Cannon Cancer Center
- Mary Crowley Cancer Research Centers Medical City
- Institute of Oncology Hematology Biomedical Research
- University of Texas Health Science Center San Antonio
- University Health Network
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Normal Renal Function: Ixazomib
Severe Renal Impairment: Ixazomib
End-stage Renal Disease: Ixazomib
In the 15 day period that constitutes Part A of the trial, participants received a single oral dose of ixazomib 3.0 mg capsules. Participants from Part A had the option of continuing the study by participating in Part B, where they received ixazomib (4, 3, or 2.3 mg per protocol) capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
In the 15 day period that constitutes Part A of the trial, participants received a single oral dose of ixazomib 3.0 mg capsules. Participants from Part A had the option of continuing the study by participating in Part B, where they received ixazomib (4, 3, or 2.3 mg per protocol) capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
In the 15 day period that constitutes Part A of the trial, participants received a single oral dose of ixazomib 3.0 mg capsules. Participants from Part A had the option of continuing the study by participating in Part B, where they received ixazomib (4, 3, or 2.3 mg per protocol) capsules, orally on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.