Mobilization of CD34+ cells with standard or reduced dose filgrastim after vinorelbine in multiple myeloma patients. A randomized prospecitve single center phase II study.

Mobilization of CD34+ cells with standard or reduced dose filgrastim after vinorelbine in multiple myeloma patients. A randomized prospecitve single center phase II study. - ONK-USZ-002

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

DRKS

Registry ID

DRKS00003251

Enrollment

Registered

2011-09-21

Start date

2011-09-20

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

C90.0

Interventions

Group 1: Standard Arm A: Filgrastim (Neupogen®) 5 µg/kg BW, BID, s.c, Start on day 4 overall 9 injections. Group 2: Experimental Arm B: Filgrastim (Neupogen®) 5 µg/kg BW, BID, s.c, Start on day 4 ov

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: All patients with multiple myeloma planned to undergo ASCT. Patients planned to receive vinorelbine for CD34+ cell mobilisation. No more than 1 induction chemotherapy (steroids only are allowed). Written informed consent.

Exclusion criteria

Exclusion criteria: Known hypersensitivity or allergy to filgrastim (Neupogen®). Active Hepatitis B/C or HIV-infection. Treatment with other investigational products. Participation in another study with investigational drug. Inability to follow the procedures of the study. Known or suspected non-compliance. Drug or alcohol abuse. Pregnancy or breast feeding. Contraindications on ethical grounds.

Design outcomes

Primary

Measure	Time frame
Feasibility of reduced dose filgrastim for mobilization of CD34+ stem cells in myeloma patients after vinorelbine administration. Number of aphereses neccessary. Median number of CD34+ stem cells collected.	—

Secondary

Measure	Time frame
Cost comparison between the two treatment arms. Evaluation of the cost of filgrastim and the cost of required analgesics. Bone pain assessment. Immune monitoring. Validation of CD 133 as alternative stem cell marker.	—

Countries

Switzerland

Contacts

Public ContactHelga Bachmann

UniversitätsSpital Zürich

helga.bachmann@usz.ch+41-44-255-4228

Outcome results

None listed

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