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

NCT05636787 | Recruiting Phase 2

• 1 other identifier: TreoMel Trial
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Melphalan; Treosulfan

Outcome Measures

Primary Outcomes (1)

• Complete Remission (CR) Rate

  Number of patients experiencing CR ( Myeloma assessment (serum free light chain ratio, M-gradient, IgG, IgA, IgM), Flow cytometry MRD, FISH analysis (plasma), Bone marrow (aspirate and biopsy) is performed only in patients fulfilling the criteria for CR. Bone marrow should be assessed at the end of the ASCT hospitalization)

  15 days after ASCT

Secondary Outcomes (9)

• Adverse Events

  15 days after ASCT

• Infectious complications

  15 days after ASCT

• Engraftment and hematologic recovery

  15 days after ASCT

• Renal toxicity

  15 days after ASCT

• Overall survival

  5 years

Study Arms (2)

Arm B - TreoMel

EXPERIMENTAL

Chemotherapy regime consisting of treosulfan on three days at 14 g/m2 followed by 200 mg/m2 melphalan given on two days at 100 mg/m2.

Drug: Treosulfan; Drug: Melphalan

Arm A - Mel

ACTIVE COMPARATOR

Chemotherapy regime consisting of 200 mg/m2 melphalan, split into two days à 100 mg/m2.

Drug: Melphalan

Interventions

Treosulfan DRUG

Efficacy of standard treatment melphalan will be compared to the combination melphalan with treosulfan

Arm B - TreoMel

Melphalan DRUG

Efficacy of standard treatment melphalan will be compared to the combination melphalan with treosulfan

Arm A - Mel; Arm B - TreoMel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Departement of Medical Oncology, University Hospital Berne

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma

Interventions

treosulfan; Melphalan

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Thomas Pabst, Prof Dr. med

  Department for Medical Oncology; University Hospital/Inselspital

  STUDY CHAIR

Central Study Contacts

Thomas Pabst, Prof Dr. med

CONTACT

+41 31 632 84 30; thomas.pabst@insel.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized prospective non-blinded clinical phase II trial

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 5, 2022
• Study Start: June 6, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 8, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)