KCT0003345
Not yet recruiting
未知
A phase II trial to evaluate the efficacy of daratumumab with DCEP in Multiply Myeloma patients with Plasmacytoma who fail to achieve complete remission with bortezomib containing induction regimen
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Seoul National University Hospital
- Enrollment
- 33
- Status
- Not yet recruiting
- Last Updated
- 7 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •?over 19 years old
- •?Patient is accompanied by a bone marrow extracellular cell that meets the diagnostic criteria of the International Myeloma Working Group multiple myeloma and is confirmed by a biopsy with a maximum diameter of at least 1 centimeter in computerized tomography or magnetic resonance imaging or Positron emission tomography\-computed tomography at the time of scanning
- •?Patients who have failed to obtain Bortezomib\-based induced cancer treatment after performing at least two cycles of Bortezomib\-based therapy.
- •?Blood test indicates proper bone marrow and organ function
- •i.White blood cells \=3000
- •ii.Absolute neutrophil count \=1500
- •iii.Platelets \=50,000 (In case of a bone marrow transfer, it is allowed to register after improvement through the use of dexamethasone 10 mg 4 day. No blood transfusions are allowed within two weeks)
- •iv.Hemoglobin \>7\.5mg/dL (No blood transfusions are allowed within two weeks)
- •v.Total bilirubin \<1\.5 times upper limit of normal
- •vi.Aspartate aminotransferase and Alanine aminotransferase \<1\.5 times upper limit of normal
Exclusion Criteria
- •? In case self\- or homogenous hematopoietic stem cell transplants are performed within 12 weeks to treat multiple myeloma
- •?In case of using immunodeficiency drugs for multiple myeloma, chemotherapy or radiotherapy for extrasolar cells within two weeks.
- •? High\-capacity steroids used in relation to clinical symptoms,
- •(However, a total of 40 mg or less is permitted to be used in order to improve blood loss symptoms including platelets reduction.)
- •? If previously treated with DCEP regimen (Except if used for mobilization)
- •? When there was a central nervous system invasive at the point of entry into the diagnosis or study
- •?If there are symptoms of myocardial infarction, cerebral infarction, cerebral hemorrhage, or uncontrolled angina within six months, then new York Heart Association (New York Heart Association Class III or IV)
- •? In case there is an unregulated dynamic pulley discharge (COPD) or continuous asthma history within 6 months
- •? In case other malignant tumors were diagnosed in the last five years other than multiple myeloma.
- •However, it excludes flat epithelial cell cervical cancer and skin cancer, which do not have a history of chemotherapy after complete local control.
Outcomes
Primary Outcomes
Not specified
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