multiple myeloma
Conditions
Interventions
case series:No
Sponsors
West China Hospital, Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Subjects aged >= 18 years; 2. Patients diagnosed as symptomatic multiple myeloma according to the IMWG 2014 diagnostic criteria; 3. According to IMWG standard disease can be measured: there are evaluable blood and urine M protein indicators (serum M-protein >=1g/dL (>=10 g/L), if it is a subject with IgA, IgD, IgE or IgM multiple myeloma , then >= 0.5 g/dL (>=5 g/L); or urine M-protein level >= 200 mg/24 hours; or light chain multiple myeloma, no measurable foci in serum or urine, serum immunoglobulin Free light chain (FLC) >= 10 mg/dL and abnormal serum immunoglobulin kappa/lambda FLC ratio), or there is a measurable extramedullary mass; 4. Functional constipation according to the Roman IV diagnostic criteria; 5. Absolute neutrophil count >= 1.0 x 10^9/L; 6. Platelet count >= 75 x 10^9/L; 7. Voluntary written consent; 8. Patients willing and able to adhere to the study schedule and management.
Exclusion criteria
Exclusion criteria: 1. Known allergy to Ixazomib,its analogues, or excipients in the various formulations; 2. The patient who had cardiovascular and cerebrovascular events such as acute myocardial infarction, acute heart failure, acute cerebral infarction or acute cerebral hemorrhage in the past half a month; 3. Patient has >=Grade 2 PN, or Grade 1 with pain on clinical examination at the time of enrollment; 4. Patients planning to participate in any interventional clinical trial; 5. Other conditions considered by the investigator to be unsuitable for inclusion, due to any serious medical or mental illness and other reasons that may hinder their compliance with the study protocol and follow-up time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| totally relaxed;Very good partial relief;2-year progression free survival;PAC-SYM constipation assessment scale;PAC-QOL constipation assessment scale;Wexner constipation assessment scale;Incidence of adverse events; | — |
Countries
China
Contacts
Public ContactZhang Li
West China Hospital, Sichuan University
Outcome results
None listed