multiple myeloma MedDRA version: 20.0 Level: LLT Classification code 10028228 Term: Multiple myeloma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Ninlaro
Product Name: Ninlaro
Product Code: EMEA/H/C/003844
Pharmaceutical Form: Capsule
INN or Proposed INN: Ixazomib
CAS Number: 1072833-77-2
Other descriptive name: IXAZOMIB
Concentrati
Sponsors
Odense University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • 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 (appendix 1). • 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 (see appendix 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, at the same time, 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 (ie, 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.) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Treatment with denosumab within the last 4 weeks. • Known concurrent malignancy (last five years), excluding skin cancer. • Known hypersensitivity to Ixazomib. • Central nervous system involvement. • Ongoing or active systemic infection, active hepatitis B or C virus infection, or known human immunodeficiency virus (HIV) positive. • Pregnant or lactating women. • Absolute neutrophil count 1.5 x the upper limit of the normal range. • Alanine aminotransferase >3 x upper limit of the normal range. • Calculated creatinine clearance 1.5 x the upper limit of the normal range (ULN). • Radiotherapy within 14 days before inclusion. • Major surgery within 14 days before inclusion. • Evidence of current uncontrolled cardiovascular conditions, including uncontrolledhypertension, uncontrolled cardiac arrhythmias, uncontrolled congestive heart failure,unstable angina, or myocardial infarction within the past 6 months. • Systemic treatment with strong CYP3A inducers (rifampin, rifapentine, rifabutin,carbamazepine, phenytoin, phenobarbital) or use of St. John’s wort. • Peripheral neuropathy grade 1 with pain or grade 2. • 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 the duration of this trial. • Known GI disease or GI procedure that could interfere with the oral absorption or tolerance of Ixazomibzomib including difficulty swallowing. • Infection requiring systemic antibiotic therapy or other serious infection within 14 days before study enrollment. • Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to this protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to investigate if treatment with ixazomib can cause healing of preexisting osteolytic bone lesions in Multiple Myeloma. ;Secondary Objective: Increased bone formation during Ixazomib treatment in NaF PET. Increased bone anabolism during Ixazomib treatment. Increased bone formation to bone degradation ratio during Ixazomib treatment. Increased bone formation using bone histomorphometric evaluation. Investigate safety and toxicities during Ixazomib treatment. Depth of cancer response to Ixazomib treatment. Adherence to therapy. ;Primary end point(s): Healing of preexisting osteolytic bone lesions in Multiple Myeloma. ;Timepoint(s) of evaluation of this end point: after 3 months and 2 years of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Increased bone formation during Ixazomib treatment in NaF PET. Increased bone anabolism during Ixazomib treatment. Increased bone formation to bone degradation ratio during Ixazomib treatment. Increased bone formation using bone histomorphometric evaluation. Investigate safety and toxicities during Ixazomib treatment. Depth of cancer response to Ixazomib treatment. Adherence to therapy. ;Timepoint(s) of evaluation of this end point: secondary endpoints will be evaluated continuously during the trial | — |
Countries
Denmark
Contacts
Public ContactOdense University Hospital
Odense University Hospital
Outcome results
None listed