Overview

Daratumumab With DCEP for Multiple Myeloma With Plasmacytoma

Status:
Unknown status

Trial end date:
2021-09-30

Target enrollment:
0

Participant gender:
All

Summary

This trial aimed to investigate the therapeutic efficacy of daratumumnab plus chemitherapy in multiple myeloma with plasmacytoma.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Seoul National University Hospital

Treatments:

Antibodies, Monoclonal
Daratumumab

Criteria

Inclusion Criteria:

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 Criteria:

- HSCT (hematopoietic stem cell transplantation) within the last 12 weeks

- Other severe acute or