Multiple Myeloma
Conditions
Interventions
Experimental group:Midodrine Combined with Daratumumab and Dexamethasone
Sponsors
The First Affiliated Hospital of Fujian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, no gender restriction; 2.ECOG Performance Status score of 0–2; 3.Estimated life expectancy of more than 12 weeks; 4.Diagnosed with relapsed/refractory multiple myeloma (RRMM) according to the 2016 International Myeloma Working Group (IMWG) criteria, with measurable disease, meeting at least one of the following: Serum M protein >= 0.5 g/dL (>=5 g/L); Urine M protein >= 200 mg/24 hours; Abnormal serum free light chain (FLC) ratio with involved FLC level >=10 mg/dL (>=100 mg/L). 5.Previously received at least three therapies for multiple myeloma, including at least one immunomodulatory drug (e.g., lenalidomide or pomalidomide) and at least one proteasome inhibitor (e.g., bortezomib or carfilzomib), and demonstrated resistance—defined as disease progression during treatment or within 60 days after treatment discontinuation, or a response less than partial remission. 6.Prior exposure to daratumumab, either as monotherapy or in combination, with evidence of resistance—defined as disease progression during or within 60 days after the last dose of daratumumab, or a response less than remission. 7.At screening, the subject must meet the following laboratory criteria (pre-treatment values): Hemoglobin >= 6.0 g/dL (prior red blood cell transfusion or erythropoietin use permitted); Absolute neutrophil count >= 0.75 x 10^9/L (granulocyte colony-stimulating factor allowed); Platelet count >= 50 x 10^9/L (platelet transfusion to meet minimum level allowed); Aspartate aminotransferase (AST) = 50%. 8.Voluntary participation in the study, with signed informed consent obtained before screening and willingness and ability to comply with all study procedures.
Exclusion criteria
Exclusion criteria: 1.Smoldering multiple myeloma; 2.Plasma cell leukemia; 3.Diagnosis or prior treatment for other aggressive malignancies besides multiple myeloma, with the exception of malignancies that were treated with curative intent and have shown no evidence of active disease for >=3 years prior to enrollment; 4.Clinically significant cardiovascular disease, including myocardial infarction within 6 months prior to study entry, unstable angina, NYHA Class III–IV heart failure, or uncontrolled arrhythmias; 5.Uncontrolled hypertension, defined as systolic blood pressure >=160 mmHg and/or diastolic pressure >=100 mmHg despite treatment with >=3 classes of antihypertensive agents during screening; 6.Severe renal impairment, defined as creatinine clearance <30 mL/min or requiring dialysis; 7.HIV infection; 8.Pregnant women or subjects of childbearing potential intending to conceive (including male subjects whose partners plan to become pregnant); 9.Known hypersensitivity to any components of the study drugs, such as midodrine, daratumumab, or dexamethasone; 10.Any condition that, in the opinion of the investigator, may increase the subject’s risk or interfere with the study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose limiting toxicity (DLT);Incidence and severity of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Duration of Response;Progression-Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactZhiyong Zeng
The First Affiliated Hospital of Fujian Medical University
Outcome results
None listed