NCT05636787 Clinical Trial Investigating the Chemotherapeutic Compound Treosulfan (Trecondi® Ideogen) in Myeloma Patients
| NCT ID | NCT05636787 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Insel Gruppe AG, University Hospital Bern |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-06-06 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 120 participants in total. It began in 2023-06-06 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Thomas Pabst, Prof Dr. med
STUDY CHAIR
Department for Medical Oncology; University Hospital/Inselspital
Frequently Asked Questions
Who can join the NCT05636787 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05636787 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05636787 currently recruiting?
Yes, NCT05636787 is actively recruiting participants. Contact the research team at thomas.pabst@insel.ch for enrollment information.
Where is the NCT05636787 trial being conducted?
This trial is being conducted at Bern, Switzerland.
Who is sponsoring the NCT05636787 clinical trial?
NCT05636787 is sponsored by Insel Gruppe AG, University Hospital Bern. The principal investigator is Thomas Pabst, Prof Dr. med at Department for Medical Oncology; University Hospital/Inselspital. The trial plans to enroll 120 participants.