Bendamustine and Melphalan in Myeloma

• Status: Completed
• Trial end date: 2020-05-28
• Target enrollment: 0
• Participant gender: All

Summary

Two high-dose chemotherapy regimens (melphalan alone versus the combination of melphalan and bendamustine) used for conditioning treatment before autologous stem cell transplantation will be compared in a 1:1 randomization in myeloma patients. The experimental arm is the bendamustine and melphalan (BenMel) combined regimen. The melphalan alone (Mel) regimen is the control (standard) treatment. Despite remarkable progress using novel agents both for induction before ASCT as well for maintenance after ASCT, definite cure in myeloma patients remains exceptional due to residual disease escaping intensive treatment. The aim of the study is to show an improvement of the rate of complete Remission 60 days after ASCT in myeloma patients from 50% with melphalan alone to 65% with the combination of bendamustine and melphalan.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Collaborator: Mundipharma Medical Company
• Treatments: Bendamustine Hydrochloride; Melphalan

Criteria

Inclusion Criteria:

• Myeloma patients after standard first-line induction treatment. A second induction regimen in refractory myeloma patients is allowed.

• Patients must be considered being fit for subsequent consolidation with high-dose chemotherapy with melphalan with autologous stem cell support.

• Patients must be aged 18-75 years.

• Patients must have an ECOG < 3.

• Patients must have a creatinine clearance ≥ 40 ml/min.

• Patients must have a LVEF ≥ 40% within three months prior to start of study medication (Echo can be postponed to study treatment visit if clinically indicated).

• Female patients of child-bearing potential: No known pregnancy (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 chemotherapy…)

• Patients must have given voluntary written informed consent.

Exclusion Criteria:

• Patients with uncontrolled acute infection.

• Patients with a transplantation comorbidity index (HCTCI) > 6 points.

• Patients with concurrent 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 24 months before registration and no evidence of active disease shall be documented since then.

• Patients with major coagulopathy or bleeding disorder.

• Patients with other serious medical condition 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.

• Pregnancy or lactating female patients.

• The 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.