Tests treosulfan with melphalan before stem cell transplant in myeloma
Compares treosulfan plus melphalan with melphalan alone before stem cell transplant in myeloma.
Plain-language title generated from the registry record
Registry title: Clinical Trial Investigating the Chemotherapeutic Compound Treosulfan (Trecondi® Ideogen) in Myeloma Patients
Key facts
- Where
- Bern, SwitzerlandSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT05636787, who can take part
Where in Switzerland
- Departement of Medical Oncology, University Hospital BerneBern, SwitzerlandTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Insel Gruppe AG, University Hospital Bern
- Trial code
- NCT05636787
- Record updated
- 8 July 2024
- Original description
Clinical trial investigating the chemotherapeutic compound treosulfan (Trecondi® Ideogen) in myeloma patients.Read full original descriptionShow less
A Randomized Phase II Trial Comparing Treosulfan and Melphalan With Melphalan Alone as Conditioning Regimen for Autologous Stem Cell Transplantation (ASCT) in Myeloma Patients (TreoMel Trial)
Clinical trial investigating the chemotherapeutic compound treosulfan (Trecondi® Ideogen) in myeloma patients.
Inclusion: Eligible are myeloma patients after standard first-line induction treatment. Additional induction regimens in refractory myeloma patients are allowed; Patients must be considered fit for subsequent consolidation with high-dose chemotherapy with autologous stem cell transplantation; Patients must be aged 18-75 years; Patients must have an ECOG <3; Patients must have a creatinine clearance ≥35 ml/min; Patients must have an LVEF ≥40% within three months prior to start of study HDCT; Patients must have given voluntary written informed consent.
Exclusion: Patients with a transplantation comorbidity index (HCTCI) > 6 points; 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; 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; Use of any anti-cancer investigational agents within 14 days prior to the expected start of trial treatment; Patients with an uncontrolled acute infection; Patients with major coagulopathy or bleeding disorder; 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; Contraindications and hypersensitivity to any of the active chemotherapy compounds; Lack of patient cooperation to allow study treatment as outlined in this protocol.