Status:
UNKNOWN
Daratumumab With DCEP for Multiple Myeloma With Plasmacytoma
Lead Sponsor:
Seoul National University Hospital
Conditions:
Multiple Myeloma in Relapse
Plasmacytoma
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
This trial aimed to investigate the therapeutic efficacy of daratumumnab plus chemitherapy in multiple myeloma with plasmacytoma.
Detailed Description
Multiple myeloma with plasmacytoma is a disease with significantly short overall survival. Cancer cells in plasmacytoma has inferior response compared to cancer cells in bone marrow in multiple myelom...
Eligibility Criteria
Inclusion
- ECOG performance status 2 or better Adequate physical condition that could tolerate cytotoxic chemotherapy judged by investigator Relapsed/Refractory Multiple myeloma with plasmacytoma Adequate cardiac function , hepatic and renal function Adequate hematopoietic function i. White blood cells ≥3000 ii. Absolute neutrophil count ≥1500 iii. Platelets ≥50,000 iv. Hemoglobin \>7.5mg/dL ( Transfusion is not permitted within 2 weeks.) v. Total bilirubin \<1.5 times upper limit of normal vi. AST and ALT \<1.5 times upper limit of normal vii. Serum creatinine \<1.5 times upper limit of normal Singed and dated informed consent of document indicating that the patient(or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment For women of child bearing age, it should be confirmed that they are not pregnant and that they should be contraception during the study period and for up to 3 months after the end of study Male should agree to the barrier method during the study period and up to 3 months after the end of the study
Exclusion
- HSCT (hematopoietic stem cell transplantation) within the last 12 weeks
- Other severe acute or
Key Trial Info
Start Date :
January 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04065308
Start Date
January 14 2019
End Date
September 30 2021
Last Update
August 22 2019
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea