Multiple myeloma
Conditions
Interventions
KRD:Carfilzomib was combined with lenalidomide and dexamethasone
Sponsors
Qingdao Municipal Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: To be enrolled in study treatment, patients must meet the following criteria: 1) Age 18 years, male and female; clearly understand the trial content, seek informed consent from patients and family members to participate in and complete the trial, and sign the informed consent voluntarily 2) Symptomatic multiple myeloma was diagnosed by the 2014 IMWG multiple myeloma diagnostic criteria, and was characterized by the presence of measurable secretory disease a) Left ventricular ejection fraction (LVEF) 40%; b) Platelet count 50×10^9 / L, absolute neutrophil count 1×10^9 / L, and hemoglobin 8.0 g/dl, respectively 3) Women of childbearing age had a negative pregnancy examination before enrollment, and agreed to use contraception during the study and within 3 months after the last treatment; 4) ECOG score of 0-2; 5) Estimated survival period of at least 12 weeks;
Exclusion criteria
Exclusion criteria: One of the following conditions will not be included in this trial 1) Inactive multiple myeloma, associated with extramedullary lesions, primary amyloidosis, MGUS (monoclonal gammaglobulinopathy of unknown significance), Chinese macroglobulinaemia, POEMS syndrome, plasma cell leukemia, or smoldering myeloma; 2) Patients with relapsed and refractory MM: disease progression during treatment after at least the remission of MR efficacy or disease progression within 60 days after the last treatment; 3) Patients with primary refractory MM: developed disease progression during treatment, and did not achieve at least minimal remission (MR) or above in treatment; 4) Patients who have previously received other anti-tumor therapy; 5) History of other malignant tumors except multiple myeloma within 3 years prior to screening (except for cured malignant tumors with a very low risk of recurrence within 3 years); 6) Psytic subjects with difficult control; 7) Subjects considered unsuitable by the investigator to participate in the trial.(Any clinically significant medical condition that may affect protocol adherence or the subject's ability to provide informed consent) ? The patient had a history of allergy to epoxketone proteasome inhibitors and / or immunomodulators; ? Known significant cardiac abnormalities include: a) Congestive heart failure, New York Heart Association (NYHA) grade III or IV b) Uncontrolled angina pectoris, cardiac arrhythmia, or hypertension c) A myocardial infarction within the past 4 months d) Clinically significant pericardial disease or cardiac amyloidosis. e) Any other uncontrolled or severe cardiovascular disease ? Women are during pregnancy or breastfeeding. ? Based on subject self-report or medical record review, evidence of any of the following: a) Major surgery or severe traumatic injury within 4 weeks before enrollment; b) Active infection with hepatitis B virus or hepatitis C virus, known infection with human immunodeficiency virus (HIV); c) Patients with inflammatory bowel disease and other immune-related diseases; d) Active infections that require anti-infection treatment with intravenous fluids; e) Other malignancies, uncontrollable infections, serious somatic or mental diseases may interfere with the participation in this clinical study; ? Psychiatric patients and potential impact informed consent signed and disease consultation follow-up of serious mental illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients with NDMM = very good partial response rate after induction therapy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate after induction, ASCT, and consolidation therapy;complete remission rate;Patients were evaluated for the rate of negative conversion of minimal residual disease when the response reached = CR;Progression-Free-Survival;Overall Survival;Duration of Response;1-year sustained MRD negativity rate;1-year progression-free survival;1-year overall survival;Safety;Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactYuping Zhong
Qingdao Municipal Hospital
Outcome results
None listed