Prophylactic administation of pegylated granulocyte colony-stimulating factor in relapsed or refractory multiple myeloma who received pomalidomide-containing regimen

Open-labeled, multicenter phase II study of prophylactic administration of pegylated granulocyte colony-stimulating factor in relapsed or refractory multiple myeloma who received pomalidomide/dexamethasone-containing regimens

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0002985

Enrollment

Registered

2018-07-05

Start date

2018-08-01

Completion date

Unknown

Last updated

2025-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Pegfilgrastim 6 mg SC on day 1 for 4 cycles of pomalidomide and dexamethasone-containing regimen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (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.

Exclusion criteria

Exclusion criteria: (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 3 X normal range (6) Renal failure with hemodialysis or peritoneal dialysis (7) Presence of Uncontrolled severe infection (8) Pregnant or lactating female

Design outcomes

Primary

Measure	Time frame
the incidence of severe neutropenia;the incidence of febrile neutropenia	—

Secondary

Measure	Time frame
Duration of severe neutropenia;Frequency and duration of administation;Adverse events associated with pegfilgratim;change of immune function	—

Countries

Korea, Republic of

Contacts

Public ContactSung-Hoon Jung

Chonnam National University Hospital Hwasun Hospital

shglory@hanmail.net+82-61-379-7629

Outcome results