Multiple myeloma
Conditions
Interventions
ITd:ITd for 6 cycles as intinal treatment and IT maintenance therapy for a maximum of 26 cycles(24 months).
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 years or older; 2. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care; 3. Previously untreated, symptomatic multiple myeloma as defined by the 3 criteria below: Monoclonal plasma cells in the bone marrow >=10% and/or presence of a biopsy-proven plasmacytoma; Monoclonal protein present in the serum and/or urine; Myeloma-related organ dysfunction (at least one of the following): [C] Calcium elevation in the blood (serum calcium >10.5 mg/l or upper limit of normal); [R] Renal insufficiency (serum creatinine >2 mg/dL); [A] Anemia (hemoglobin =1 g/dL (>=10 g/L); Urine M-protein >=200 mg/24 hours; Serum free light chain assay: involved free light chain level >=10 mg/dL (>=100 mg/L), provided that the serum free light chain ratio is abnormal; 5. 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 Male patients: Agree to practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug; 6. Transplant-ineligible or patients refused to take transplantation; 7. Eastern Cooperative Oncology Group (ECOG) performance status and/or other performance status 0, 1, 2. 8. Patients must meet the following clinical laboratory criteria: Absolute neutrophil count (ANC) >=1,000/mm*3 and platelet count >=75,000/mm*3. Platelet transfusions to help patients meet eligibility criteria are not allowed within 3 days before study enrollment; Total bilirubin =30 mL/min.
Exclusion criteria
Exclusion criteria: 1. Previous treatment with antimyeloma therapy(Except for receiving dexamethasone treatment(40mg/d) up to four times); 2. Female patients who are lactating or have a positive serum pregnancy test during the screening period; 3. Failure to have fully recovered (ie, =Grade 3 peripheral neuropathy, or >=Grade 2 with pain on clinical examination during the screening period; 16. 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; 17. Patients that have previously been treated with ixazomib, or participated in a study with ixazomib whether treated with ixazomib or not.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 years VGPR or better( CR+VGPR) rate as best response based on IMWG criteria, evaluated by investigator;ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| safety;2-years PFS rate;;2-years OS rate;;Efficacy parameter in different stratification groups;;2 years MRD negative rate.; | — |
Countries
China
Contacts
Public ContactLu Jin
Peking University People's Hospital
Outcome results
None listed