Bone Healing During Ninlaro Exposure

Prior treatment

• Treatment with Denosumab within the last 4 weeks.
• Known concurrent malignancy (last five years), excluding skin cancer.
• Radiotherapy within 14 days before inclusion.
• Major surgery within 14 days before inclusion.
• Systemic treatment with strong CYP3A inducers (rifampin, rifapentine, rifabutin, carbamazepine, phenytoin, phenobarbital) or use of St. John's wort.
• Participation in other clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout its.
• Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment.

Other illness

• Known hypersensitivity to Ixazomib.
• Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive Pregnant or lactating women
• Evidence of current uncontrolled cardiovascular conditions, including uncontrolled hypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure, unstable angina, or myocardial infarction within the past 6 months.
• Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of Ixazomibzomib including difficulty swallowing.

Lab values

• Absolute neutrophil count \< 1,000mm3 without growth factor support.
• Platelet count \< 75,000/mm3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before inclusion -Total bilirubin \> 1.5 x the upper limit of the normal range.
• Calculated creatinine clearance \< 30 mL/min (using the Cockcroft-Gault equation).
• Total bilirubin \> 1.5 the upper limit of the normal range (ULN).

Other

• Central nervous system involvement.
• Alanine aminotransferase \> 3 x upper limit of the normal range.
• Peripheral neuropathy grade 1 with pain or grade 2.

• Symptomatic Multiple Myeloma according to the IMWG criteria.
• Detectable osteolysis on low dose CT (at least 5 mm in size).
• Stable disease, defined as no signs of progressive disease for three months without anti myeloma treatment.
• Achieved, partial response or better, during last line of therapy.
• Signed informed consent.
• Age ≥ 18 years.
• Remaining life expectancy ≥ 6 months.
• ECOG performance status 0-2.
  • Female patients who
• Are postmenopausal for at least 1 year before the screening visit, OR
• Are surgically sterile, OR
• If they are of childbearing potential, agree to practice 2 effective methods of contraception, simultaneously, from the time of signing the informed consent form through 90 days after the last dose of study drug, OR
• Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception).
  • Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following
• Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, OR
• Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception).