Relapsed and/or Refractory Multiple Myeloma
Conditions
Interventions
Ixazomib(4mg) + Lenalidomide + Dexamethasone
Ixazomib(3mg) + Lenalidomide + Dexamethasone
Ixazomib(3mg) + Lenalidomide + Dexamethasone
Sponsors
Kobe University Hospital, Medical Oncology / Hematology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Men and women of age 20 years or older at the consent acquisition date (2)Performance status of 0-2 according to the Eastern Cooperative Oncology Group (ECOG) scale. (3)Patients with RRMM (4) The latest inspection value within 14 days before registration meets all of the following. The evaluation of CCr and T-Bil is different Two bleeds (that is not possible on the same date) will be subject to both criteria. [Renal disorder cohort] 1. Number of neutrophils >= 1,000/uL 2. Platelet count >= 75,000 / uL 3. AST <= 90 U / L: 3 times or less than normal upper limit value 4. ALT <=126 U / L (male) or 69 U / L (female): 3 times or less of normal upper limit 5. T-Bil <= 2.25 mg / mL: 1.5 times or less of normal upper limit value 6. CCr <= 30 mL / min [Liver disorder cohort] 1. Number of neutrophils >= 1,000 / uL 2. Platelet count >= 75,000 / uL 3. T-Bil> 2.25 mg / mL: exceeds 1.5 normal upper limit 4. CCr> 30 mL / min (6) Survival of more than 6 months can be expected from the date of registration. (7) With regard to participation in this examination, document consent was obtained by the volunteer's free will.
Exclusion criteria
Exclusion criteria: (1) Patients with another active malignancy (2) Patients who underwent surgical operations requiring general anesthesia within 14 days before registration (3) have active infection requiring systemic treatment. (4) has central invasive lesion of multiple myeloma / plasmacytoma. (5) have poorly controlled cardiovascular disease (hypertension, arrhythmia, heart failure, unstable angina or myocardial infarction that developed within 6 months before enrollment). (6) Active HBV infection (Hbs antigen positive and HBV-DNA positive) and HCV infection (HCV antibody positive and HCV-RNA positive), or known HIV infection. (7) Severe complications (active gastrointestinal ulcer, intestinal palsy, intestinal obstruction, inflammatory bowel disease, interstitial pneumonia or pulmonary fibrosis, poorly controlled diabetes etc.). (8) Patients whose mental illness or psychiatric symptoms, which interferes with daily life, are merged and judged to be difficult to participate in the examination. (9) Patients who are considered difficult to participate in the exam because of complicated with psychiatric disorders or psychiatric symptoms that interfere with daily living (10) Patients who are hypersensitive to test drugs and their analogs and additivesients whose oral medications are difficult to administer or whose administration conditions can not be observed or whose undergoing gastrointestinal procedures that affect oral drug absorption and tolerability. (11) pregnant women,Lactating women,or a woman with the possibility (or intention). of a pregnant. (12) patients undergoing systemic administration of strong CYP1A2 inhibitors (fluvoxamine, ciprofloxacin), potent CYP3A inhibitors (clarithromycin, itraconazole, voriconazole), potent CYP3A inducers (rifampicin, rifabutin, carbamazepine, Phenytoin, Phenobarbital), ginkgo biloba or St. John's Wort. (13) Patients who are judged inappropriate as subjects of this study by an investigator or a test sharing doctor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The AUC of the severe renal impairment cohort | — |
Secondary
| Measure | Time frame |
|---|---|
| The PK(Cmax, Tmax) of the severe renal impairment cohort Overall response rate at 24 weeks from the start of study treatment [renal impairment cohort] Overall survival rate at 24 weeks from the start of study treatment [renal impairment cohort] Adverse events and serious adverse events from the start of the study treatment up to 24 weeks.[renal impairment cohort] The PK (AUC, Cmax, Tmax) of the severe hepatic impairment cohort Overall response rate at 24 weeks from the start of study treatment [hepatic impairment cohort] Overall survival rate at 24 weeks from the start of study treatment [hepatic impairment cohort] Adverse events and serious adverse events from the start of the study treatment up to 24 weeks [hepatic impairment cohort] Overall survival rate at 52 weeks from the start of study treatment [renal impairment cohort, hepatic impairment cohort] PPK parameters of Ixazomib [renal impairment cohort, hepatic impairment cohort] PK parameters of Lenalidomide [renal impairment cohort, hepatic impairment cohort] PPK parameters of Lenalidomide [renal impairment cohort, hepatic impairment cohort] | — |
Countries
Japan
Contacts
Public ContactAkihito Kitao
Kobe University Hospital Medical Oncology / Hematology
Outcome results
None listed