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Recruiting Phase 2 NCT05636787

Clinical Trial Investigating the Chemotherapeutic Compound Treosulfan (Trecondi® Ideogen) in Myeloma Patients

Trial Parameters

Condition Multiple Myeloma
Sponsor Insel Gruppe AG, University Hospital Bern
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 120
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2023-06-06
Completion 2028-01
Interventions
TreosulfanMelphalan

Brief Summary

Clinical trial investigating the chemotherapeutic compound treosulfan (Trecondi® Ideogen) in myeloma patients.

Eligibility Criteria

Inclusion criteria: 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. Exclusion criteria: 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

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