multiple myeloma
Conditions
Interventions
case group:Nil
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Subjects will be enrolled in this study only if they met all of the following inclusion criteria. 1.Age 18 years or older, regardless of gender. 2.Diagnosis of symptomatic multiple myeloma based on the 2014 IMWG diagnostic criteria and the presence of measurable disease, as defined by any of the following: 1)IgG myeloma: serum M protein level = 10g/L or urinary M protein level = 200 mg/24 hours; or 2)IgA, IgD, IgM or IgE myeloma: serum M protein level = 5g/L or urine M protein level = 200 mg/24 hours; or 3)Light chain myeloma: serum immunoglobulin free light chain = 100mg/L and abnormal serum immunoglobulin kappa lambda free light chain ratio; 3.First relapse of multiple myeloma; 1)Receiving first-line anti-multiple myeloma therapy; 2)The first-line therapy must be based on proteasome inhibitors and immunomodulators (RVD); 3)Achieve =PR to initial therapy. 4)RRMM: Meeting the response criteria for PD based on International Myeloma Working Group (IMWG) response criteria; 4.Each subject (or their legally acceptable representative) must sign an informed consent form indicating that he or she is willing to participate in the study; 5.Women of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use contraception during the study and for 3 months after the last treatment;
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Any potential subject who meets any of the following criteria will be excluded from participating in the study: 1)Diagnosis of inactive multiple myeloma, including primary amyloidosis, MGUS (monoclonal gammopathy of undetermined significance) or smoldering myeloma. 2)Relapsed and refractory myeloma:Relapsed and refractory myeloma is defined as disease that is nonresponsive while on salvage therapy, or progresses within 60 days of last therapy in patients who have achieved minimal response (MR) or better at some point previously before then progressing in their disease course; 3)Primary refractory myeloma:Primary refractory myeloma is defined as disease that is nonresponsive in patients who have never achieved a minimal response or better with any therapy; 4)Exposure history of first-line daratumumab and pomalidomide; 5)Subject has a history of malignancy within 3 years before the date of screening (except for cured malignancies with minimal risk of recurrence within 3 years); 6)Subjects with uncontrollable psychiatric disorders; 7)Subjects who, in the opinion of the investigator, are not suitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS2; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate, ORR;Deep response rate;MRD negative and continuous MRD negative rate;The impact of sustained negative MRD on PFS2;Overall survival ; | — |
Countries
China
Contacts
Public ContactFengyan JIin
The First Hospital of Jilin University
Outcome results
None listed