Prophylactic administation of pegylated granulocyte colony-stimulating factor in relapsed or refractory multiple myeloma who received pomalidomide-containing regime
- Conditions
- Neoplasms
- Registration Number
- KCT0002985
- Lead Sponsor
- Chonnam National University Hospital Hwasun Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 33
(1) Relapsed or refractory multiple myeloma who received pomalidomide and dexamethasone-containing regimen
(2) Absolute neutrophil count = 15,000/µL at screening
(3) Age = 19 years
(4) ECOG PS = 2
(5) Subjects must have signed an informed consent document indicating that they understand purpose
of and procedures required for the study and are willing to participate in the study.
(1) Smoldering myeloma
(2) Primary or secondary plasma cell leukemia
(3) History of radiation therapy within 4 weeks prior to enrolment
(4) Patients who have hypersensitivity to pegfilgrastim
(5) Presence of abnormal result of baseline test
Platelet count < 50,000 cells/µL (50 x 109/L) (when patients do not received a blood transfusion)
Serum AST or ALT > 3 X normal range
(6) Renal failure with hemodialysis or peritoneal dialysis
(7) Presence of Uncontrolled severe infection
(8) Pregnant or lactating female
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the incidence of severe neutropenia;the incidence of febrile neutropenia
- Secondary Outcome Measures
Name Time Method Duration of severe neutropenia;Frequency and duration of administation;Adverse events associated with pegfilgratim;change of immune function