RecruitingPhase 2NCT05636787

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

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)

Sponsor

Insel Gruppe AG, University Hospital Bern

Enrollment

120 participants

Start Date

Jun 6, 2023

Study Type

INTERVENTIONAL

Conditions

Multiple Myeloma

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria10

Patients with an uncontrolled acute infection.
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.
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.
Lack of patient cooperation to allow study treatment as outlined in this protocol.
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.
Contraindications and hypersensitivity to any of the active chemotherapy compounds.