Clinical trial · Interventional
Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma
Assessment of the Efficacy and Tolerance, and Health Economic Study of a Single Administration of Pegfilgrastim in Lymphoma or Myeloma Patients Treated With Intensive Chemotherapy and Autologous Peripheral Stem Cell Transplantation
- 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)
The purpose of this study is to evaluate the efficacy and tolerance of a single administration of Pegfilgrastim in patients with lymphoma or myeloma receiving high-dose chemotherapy and autologous peripheral stem cell support, and to estimate the costs incurred. Eligible patients will be randomized. The estimated inclusion period is approximately 18 months. The duration of the research is 22 months. The maximum duration of participation for each patient is 3 months. The number of patients required in this multicentric and prospective study is 150 (13 participating centers). This is a phase II, controlled, randomized, non comparative and open-label multicentric study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myeloma | Multiple Myeloma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection of Filgrastim | Drug | — | UNRESOLVED |
| Injection of Pegfilgrastim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pegfilgrastim
- description
- Single subcutaneous administration of Pegfilgrastim (Neulasta® - Laboratory AMGEN) 6 mg at D5
- interventionNames
- Drug: Injection of Pegfilgrastim
- type
- ACTIVE_COMPARATOR
- label
- Filgrastim
- description
- Daily subcutaneous administration of Filgrastim (Neupogen® - Laboratory AMGEN) 5 µg/kg/day from D5 until recovery from aplasia (PNN \> 0.5 G/L)
- interventionNames
- Drug: Injection of Filgrastim
Primary outcomes (1)
- measure
- Efficacy of a single administration of Pegfilgrastim at D5 in shortening the duration of febrile neutropenia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female patients aged ≥ 18 years * Patients with histologically confirmed lymphoma or myeloma * Treatment with high-dose chemotherapy before inclusion * Intensification with high dose Melphalan for patients with myeloma * Whatever the conditioning regimen, except TBI for patients with 1st relapse of Hodgkin's lymphoma or with MNHL NB: Patients having received two intensification courses are eligible if there has been more than 100 days between courses. * Autologous PSC transplantation at the time of inclusion * Reinjection of ≥ 2.106 CD34/kg * Patients hospitalized in the investigator center throughout the procedure until recovery from aplasia (PNN \> 0.5 G/L) * Mandatory affiliation with a health insurance system * Patients able to understand, read and write French * Signed, written informed consent Exclusion Criteria: * TBI during conditioning * Severe intolerance to the growth factor under study, or hypersensitivity to one of their components * Immunosuppressive syndrome * Pregnant or lactating women * Difficult follow-up * Documented history of cognitive or psychiatric disorders * Participation or consideration of participation in another biomedical study during the follow-up period of the present trial.
References
Publications (0)
Data not yet available