Comparison of Treosulfan with Melphalan versus Melphalan alone in high-dose chemotherapy prior to autologous transplantation in patients with multiple myeloma

Switzerland (ICTRP)

ICTRP Studien-ID
NCT05636787 (ICTRP)

Offizieller Titel (Genehmigt von der Ethikkommission)
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). (BASEC)

Wissenschaftlicher Titel
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) (ICTRP)

Öffentlicher Titel
Clinical Trial Investigating the Chemotherapeutic Compound Treosulfan (Trecondi? Ideogen) in Myeloma Patients (ICTRP)

Untersuchte Krankheit(en)
Multiple Myeloma (ICTRP)

Untersuchte Intervention
Drug: Treosulfan;Drug: Melphalan (ICTRP)

Studientyp
Interventional (ICTRP)

Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)

Ein-/Ausschlusskriterien
Gender: All
Maximum age: 75 Years
Minimum age: 18 Years
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. (ICTRP)

nicht verfügbar

Primäre und sekundäre Endpunkte
Complete Remission (CR) Rate (ICTRP)

Adverse Events;Infectious complications;Engraftment and hematologic recovery;Renal toxicity;Overall survival;Progression free survival;Hospitalisation duration;Minimal residual disease (MDR);Pharmacodynamics of Treosulfan (ICTRP)

Registrierungsdatum
23.11.2022 (ICTRP)

Einschluss des ersten Teilnehmers
nicht verfügbar

Sekundäre Sponsoren
nicht verfügbar

Weitere Kontakte
Thomas Pabst, Prof Dr. med;Thomas Pabst, Prof Dr. med;Thomas Pabst, MD, thomas.pabst@insel.ch, +41 31 632 84 30;+41 31 632 84 30, Department for Medical Oncology, University Hospital/Inselspital, (ICTRP)

Sekundäre IDs
TreoMel Trial (ICTRP)

Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar

Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT05636787 (ICTRP)