Clinical trial · Interventional
Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization
Pharmacokinetic and Pharmacodynamic Study of Lenograstim for Hematopoietic Stem Cell Mobilization in Patients With Multiple Myeloma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Twenty four patients with multiple myeloma will be randomized to either AM group (administration of lenograstim at 8 am) or PM group (administration of lenograstim at 6 am ). Apheresis of hematopoietic stem cell will start at 10 am on D5 in AM group and at 8 am on D4 in PM group, respectively. Pharmacokinetic data of lenograstim will be correlated with pharmacodynamic data of CD34+ cell count, absolute neutrophil cell count and hematopoeitic progenitor cell count. In addition, the yield of stem cell collection between two arms will be analyzed.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenograstim 10 microgram/kg/day | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- AM group
- description
- Lenograstim is administered at 8 am and apheresis is started at 10 am on D4.
- interventionNames
- Drug: lenograstim 10 microgram/kg/day
- type
- EXPERIMENTAL
- label
- PM group
- description
- Lenograstim is administered at 6 pm and apheresis is started at 8 am on D5
- interventionNames
- Drug: lenograstim 10 microgram/kg/day
Primary outcomes (1)
- measure
- pharmacokinetic data of lenograstim
- timeFrame
- on day 1 of apheresis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * age: above 17 years, below 65 years old * informed consent * ECOG 0-1 * autologous stem cell transplant candidate among patients with multiple myeloma Exclusion Criteria: * prior history of hematopoetic stem cell transplantation * history of failure to mobilize hematopoietic stem cells * history of G-CSF administration within 2 weeks before enrollment to this study
References
Publications (0)
Data not yet available