NCT05636787Recrutement en cours
Clinical Trial Investigating the Chemotherapeutic Compound Treosulfan (Trecondi® Ideogen) in Myeloma Patients
Résumé
Clinical trial investigating the chemotherapeutic compound treosulfan (Trecondi® Ideogen) in myeloma patients.
Critères d'inclusion
1. Eligible are myeloma patients after standard first-line induction treatment. Additional induction regimens in refractory myeloma patients are allowed. 2. Patients must be considered fit for subsequent consolidation with high-dose chemotherapy with autologous stem cell transplantation. 3. Patients must be aged 18-75 years. 4. Patients must have an ECOG \<3. 5. Patients must have a creatinine clearance ≥35 ml/min. 6. Patients must have an LVEF ≥40% within three months prior to start of study HDCT. 7. Patients must have given voluntary written informed consent.
Critères d'exclusion
1. Patients with an uncontrolled acute infection. 2. Patients with a transplantation comorbidity index (HCTCI) \> 6 points. 3. Patients with concurrent active malignant disease with the exception of basalioma/spinalioma of the skin or early-stage cervix carcinoma, or early-stage prostate cancer. Previous treatment for other malignancies (not listed above) must have been terminated at least 6 months before registration and no evidence of active disease may be documented since then. 4. Patients with major coagulopathy or bleeding disorder. 5. Patients with other medical conditions that could potentially interfere with the completion of treatment according to this protocol or that would impair tolerance to therapy or prolong hematological recovery. 6. Lack of patient cooperation to allow study treatment as outlined in this protocol. 7. Known pregnancy or lactating female patients. The pregnancy test could be omitted from the screening visit and postponed to the study treatment if indicated (a pregnancy test in female patients of child-bearing potential is not mandatory since patients are already under induction chemotherapy or mobilization chemotherapy, and pregnancy was excluded before starting induction chemotherapy; if, however, a pregnancy test is clinically indicated, it can be done either during screening or before the start of study treatment). Patient not willing to implement adequate contraceptive measures (hormonal treatment p.o. or i.m., intra-uterine surgical devices, or latex condoms) to avoid pregnancy during study treatment and for 12 additional months. 8. Use of any anti-cancer investigational agents within 14 days prior to the expected start of trial treatment. 9. Contraindications and hypersensitivity to any of the active chemotherapy compounds.
Contacts
Les coordonnées de l'équipe de l'essai s'affichent sur demande.
Voir la fiche officielle de l'essai- Statut
- Recrutement en cours
- Phase
- Phase 2
- Type d'étude
- Interventionnelle
- Pays
- Suisse
- Promoteur
- Insel Gruppe AG, University Hospital Bern(Autre)
- N° de protocole
- TreoMel Trial
- Pathologies
- Multiple Myeloma
- Interventions
- Médicament
Traitements évalués
- Treosulfan
- Melphalan
Lieux · 1
- Bern, SuisseDepartement of Medical Oncology, University Hospital BerneRecrute dans ce centre
Au total, dans le monde, le seul centre listé au registre recrute.
Statut par centre selon le registre ClinicalTrials.gov (dernière mise à jour publiée : 8 juillet 2024).
Ce statut peut avoir changé et ne dit rien de votre éligibilité : avant toute démarche, vérifiez avec votre oncologue ou le centre.
Voir aussi
Autres versions
Ces résultats sont indicatifs et ne remplacent pas un avis médical — à discuter avec votre médecin.