Last updated: August 9, 2023
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Recruiting
Phase
2
Condition
Multiple Myeloma
Cancer
Lymphoproliferative Disorders
Treatment
Dexamethasone
Bortezomib
Lenalidomide
Clinical Study ID
NCT05900882
SVRd
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Men and women aged with18-75 years old.
- Confirmed diagnosis of Multiple Myeloma(MM) (IMWG consensus guidelines)
- Newly diagnosed patients presenting with extramedullary disease (EMD) including solelyparaskeletal plasmacytoma, plasmacytoma of soft tissue and other special sitesdetected by physical exam and confirmed by CT/MRI/PET-CT and/or biopsy (≥2cm).
- ANC≥1.010^9/L, HGB≥7510^9/L, PLT≥50*10^9/L (≥50% of bone marrow nucleated cells areplasma cells).
- Patients whose expecting survival time will be more than 3 months.
- Without active infectious disease.
- Female patients of child-bearing potential must have a negative serum pregnancy testat screening and all patients agree to use two reliable methods of contraception forsix months after their last dose of medication.
- Willingness and ability to comply with scheduled visits, treatment plans, laboratorytests and other study procedures.
- Each patient must sign an informed consent form (ICF) indicating that he or sheunderstands the purpose of and procedures required for the study and are willing toparticipate in the study.
Exclusion
Exclusion Criteria:
- Patients who have HBV, HCV, and other acquired and congenital immunodeficiencydiseases.
- Patients who have grade 2 or higher of peripheral neuropathy or neuralgia according tothe definition of NCI CTCAE version 4.0.
- Plasma cell leukemia.
- Serious thrombotic events.
- Active, unstable cardiovascular dysfunction: a. symptomatic ischemia; b. Uncontrolled,clinically significant conduction abnormalities (except antiarrhythmic ventriculartachycardia), but patients with first-degree atrioventricular block or asymptomaticleft anterior bundle/right fascicular block cannot be excluded. c. New York HeartAssociation (NYHA) Class III - IV or left ventricular ejection fraction (LVEF) <40%;d. Myocardial infarction Within 3 months before C1D1.
- Significant hepatic dysfunction (ALT and AST ≥ 3 times the upper limit of normal (ULN)).
- Serum bilirubin≥1.5 × ULN.
- creatinine clearance <30 ml/min.
- History of active malignancy during the past 5 years with the exception of basalcarcinoma of the skin or stage 0 cervical carcinoma.
- Previous major operation within 30 days before C1D1.
- Patients who have epilepsy, dementia requiring medication, or other mental disorderswho are unable to understand or adhere to the study protocol.
- According to the study protocol or in the opinion of the investigator,serious physicalor mental illness that is likely to interfere with the study procedures/results.
- Any psychological, familial, sociological and geographical condition potentiallyhampering compliance with the study protocol and follow-up schedule.
- Current participation in another clinical trial.
- Pregnant or lactating women.
- Patients with other commodities that the investigators considered not suitable for theenrollment.
Study Design
Total Participants: 35
Treatment Group(s): 4
Primary Treatment: Dexamethasone
Phase: 2
Study Start date:
July 15, 2022
Estimated Completion Date:
June 30, 2025
Study Description
Connect with a study center
Changzhou Second People's Hospital
Changzhou, Jiangsu 213000
ChinaSite Not Available
Nanjing First People's Hospital
Nanjing, Jiangsu 210000
ChinaSite Not Available
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu 210029
ChinaActive - Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu 226001
ChinaSite Not Available
Taizhou People's Hospital
Taizhou, Jiangsu 225300
ChinaSite Not Available
Yancheng First People's Hospital
Yancheng, Jiangsu 224006
ChinaSite Not Available
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