Evaluation of febrile event during emopoietic progenitor cells aferesi post chemotherapy treatment in patients affected by multiple myeloma. - ND

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004885-18-IT

Enrollment

Registered

2006-04-21

Start date

2004-12-30

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Multiple myeloma MedDRA version: 6.1 Level: PT Classification code 10028228

Interventions

Trade Name: MYELOSTIM 34 1FL 263MCG 1SIR Pharmaceutical Form: Solution for injection INN or Proposed INN: Lenograstim CAS Number: 135968-09-1 Concentration unit: µg microgram(s) Concentration type: eq

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Multiple myeloma diagnosis -Time from prymary chemotherapy to HD chemotherapy between 30/60 days. -HCV HBSAG negative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: -Document or probabily infections. -Cardiological disease -Other medical conditions uncontrolled.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluation of febrile event incidence in both treatment arms.;Secondary Objective: Evaluation of quality and quantity of progenitor stem cells products.;Primary end point(s): Evaluation of febrile event incidence in both treatment arms.	—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026