Investigating Treosulfan for Myeloma Treatment

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)

This study is testing if a chemotherapy drug called treosulfan can help improve treatment for people with multiple myeloma who are preparing for a stem cell transplant.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Insel Gruppe AG, University Hospital Bern (Academic / other)
• Drugs / interventions: chemotherapy, Daratumumab
• Locations: 1 site (Bern)
• Trial ID: NCT05636787 on ClinicalTrials.gov

What this trial studies

This clinical trial is focused on evaluating the effectiveness of the chemotherapeutic compound treosulfan (Trecondi® Ideogen) in patients with multiple myeloma who have undergone standard first-line induction treatment. The study aims to improve the conditioning strategies for high-dose chemotherapy (HDCT) prior to autologous stem cell transplantation (ASCT). The trial will include patients aged 18-75 years who are deemed fit for this intensive treatment approach. The research is being conducted at the Inselspital in Bern, a leading center for ASCT in Europe.

Who should consider this trial

Good fit: Ideal candidates for this study are myeloma patients aged 18-75 who have completed standard first-line induction treatment and are fit for high-dose chemotherapy with ASCT.

Not a fit: Patients with uncontrolled acute infections or significant comorbidities that exceed the transplantation comorbidity index may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could provide a more effective treatment option for multiple myeloma patients, potentially improving their outcomes after high-dose chemotherapy.

How similar studies have performed: Previous studies have shown success with similar approaches, particularly in enhancing the efficacy of high-dose chemotherapy 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.

Where this trial is running

Bern

• Departement of Medical Oncology, University Hospital Berne — Bern, Switzerland (Recruiting)

Study contacts

• Study coordinator: Thomas Pabst, Prof Dr. med

Conditions Multiple Myeloma; Melphalan; Treosulfan