Phase 2
Completed N=120
Bendamustine and Melphalan in Myeloma
Source: ClinicalTrials.gov NCT03187223 ↗Enrolled (actual)
120
Serious AEs
17.5%
Results posted
Jan 2025
Primary outcomePrimary: Complete Remission Rate — 31; 42 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Remission Rate |
31; 42 | — |
| SECONDARY Adverse Events |
36; 43 | — |
| SECONDARY Hematologic Engraftment After High-dose Chemotherapy |
12; 11 | — |
| SECONDARY Overall Survival |
96; 96 | — |
| SECONDARY Quality of Life: EORTC Q30 Questionnaire |
— | — |
Eligibility 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 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.
Data sourced from ClinicalTrials.gov (NCT03187223). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.