Effect of Daratumumab on Myeloma EMD
- Conditions
- multiple myeloma
- Registration Number
- JPRN-jRCTs031190045
- Lead Sponsor
- Inokuchi Koiti
- Brief Summary
Due to rare cases and reports of negative data, we decided to discontinue this study. In two patients with written informed consent, EMD was reduced with PR and the response was maintained for approxiamtely one year in one patient who was entered.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1
1) Relapse/refractory multiple myeloma currently with extramedullary disease
2) Extramedullary disease, defined as plasmacytoma outside bone marrow, has a single diameter of 2 cm or more than 2 cm and at least one measurable disease as follows
serum M-protein 0.5g/dL or or more than 0.5g/dL
urine M-protein 200 mg/24h or more than 200 mg/24h
serum free light chain (involved light chain) 100 mg/L or more than 100 mg/L
3) Normal organ function
absolute neutrophil count 1000/mm3 or more than 1000/mm3
platelet count 50,000/mm3 or more than 50,000/mm3
hemoglobin 8.0 g/dL or more than 8.0 g/dL
calculated creatinine clearance (using Cockcroft-Gault equation) 30 mL/min or more than 30 mL/min or Cr 3.0mg/dL or less than 3.0mg/dL
total bilirubin upper limit x 2 or or less than upper limit x 2
ALT, AST upper limit x 3 or or less than upper limit x 3
4) Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (including PS3 according bone diseases)
5) Patients who can comply the proper procedure of RevMate
6) Provide informed written consent
7) Willing to provide bone marrow and extramedullary samples for correlative research purposes
1)pregnant or breastfeeding females
2)patients with other active neoplasm
3)patients who were previously treated with daratumumab
4)known active systemic infection
5)known hepatitis B surface antigen-positive status
6)known hepatitis C antibody-positive status
7)known human immunodeficiency virus (HIV) antibody-positive status
8)patients undergoing major surgery (except surgery for myeloma bone disease) within 14 days prior to the registration
9)patients undergoing radiation therapy within 7 days prior to the registration
10)evidence of current uncontrolled cardiovascular conditions including hypertension, cardiac arrhythmias, congestive heart failure, unstable angina, or myocardial infarction within the past 6 months
11)any serious medical or psychiatric illness that could, in the investigator's opinion,potentially interfere with the completion of treatment according to this protocol
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method extramedullary plasmacytoma response
- Secondary Outcome Measures
Name Time Method response rate of multiple myeloma <br>biochemical response<br>incidence of adverse events<br>progression-free survival<br>overall survival