multiple myeloma
Conditions
Interventions
1:no
Sponsors
Beijing Jishuitan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1 Age = 18 years, no gender limit; 2 Diagnosed with MM according to the International Myeloma Working Group criteria; patients with only light chain and free light chain disease may be enrolled if they meet all criteria for MM diagnosis; 3 Patients must have completed 6 months of DRd induction therapy and have achieved PR or better as defined by the IMWG2016 criteria; 4 Patients must be assessed by their physician as unsuitable for transplantation or, if suitable for transplantation, are not expected to undergo transplantation within 24 months of study enrollment; if clinically indicated, it is acceptable to undergo a stem cell acquisition and mobilization protocol; 5 ECOG score of 0 to 2; 6 Patients must meet the criteria for clinical laboratory testing as outlined in the information in the instructions for Ixazomib; 7 sign the informed consent.
Exclusion criteria
Exclusion criteria: 1 Participation in other interventional clinical trials within 30 days of the start of the trial and ongoing for the duration of the trial; 2 Female patients who are breastfeeding or who have a positive serum pregnancy test during screening; 3 Major surgery within 14 days prior to selection; 4 Radiation therapy within 14 days prior to enrollment; 5 Central nervous system involvement; 6 Need for systemic antibiotic therapy or other serious infection within 14 days prior to study entry; 7 Evidence of current uncontrolled cardiovascular disease, including uncontrolled hypertension, uncontrolled arrhythmia, symptomatic congestive heart failure, unstable angina pectoris, or myocardial infarction within the past 6 months; 8 Systemic treatment with strong CYP3A inducers or use of ginkgo biloba within 14 days prior to the first dose of ixazomib; 9 Active systemic infection, active hepatitis B or C virus infection, or positive for human immunodeficiency virus; 10 Any serious medical or psychiatric condition that, in the opinion of the investigator, may interfere with completion of treatment in accordance with the study protocol; 11 Patients who are known to be allergic to any study drug, its analogues, or excipients of different formulations in any preparation; 12 Gastrointestinal disorders or gastrointestinal surgery may interfere with the absorption or tolerance of oral ixazomib, including difficulty in swallowing; 13 Diagnosis or treatment of another malignancy within 2 years prior to study entry, or previous diagnosis of another malignancy with evidence of any residual lesions (patients will not be excluded if they have a non-melanoma skin cancer or any type of carcinoma in situ that has been completely excised); 14 Patients previously treated with Ixazomib; 15 Disease progression during induction therapy with the DRd.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| M protein quantification;bone marrow plasma cell percentage;progression free survival;overall survival;Bone marrow flow cytometry;bone marrow FISH;MRI / CT;Immunostationary electrophoresis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Liver and kidney function;Routine blood; | — |
Countries
China
Contacts
Public ContactLi Bao
Beijing Jishuitan Hospital, Capital Medical University
Outcome results
None listed