Bendamustine and Melphalan in Myeloma

NCT03187223 | Completed Phase 2 Results

• 1 other identifier: BEB-2 Trial
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Bendamustine; Melphalan; ASCT

Outcome Measures

Primary Outcomes (1)

• Complete Remission Rate

  Number of Patient achieving complete remissions (CR1) at 60 days after ASCT

  60 days

Secondary Outcomes (4)

• Adverse Events

  60 days

• Hematologic Engraftment After High-dose Chemotherapy

  30 days

• Overall Survival

  12 months

• Quality of Life: EORTC Q30 Questionnaire

  60 days

Study Arms (2)

Arm A (Mel)

ACTIVE COMPARATOR

Melphalan 100mg/m2/day iv days -2 and -1

Drug: Melphalan

Arm B (BenMel)

EXPERIMENTAL

Melphalan 100mg/m2/day iv days -2 and -1 Bendamustine 200mg/m2/day iv days -4 and -3

Drug: Melphalan; Drug: Bendamustine

Interventions

Melphalan DRUG

High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0.

Also known as: Alkeran

Arm A (Mel); Arm B (BenMel)

Bendamustine DRUG

High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive bendamustine at a total dose of 400mg/m2, divided in two doses of 200mg/m2/day on days -4 and -3. Melphalan is given at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day, each on days -2 and -1, with the ASCT at day 0.

Also known as: Ribomustin

Arm B (BenMel)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Mundipharma Medical Company: collaborator

Study Sites (1)

Department for Medical Oncology University Hospital/Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Melphalan; Bendamustine Hydrochloride

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; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Prof Dr. Thomas Pabst
• Organization: Department of Medical Oncology, Inselspital, University Hospital and University of Bern, Bern, Switzerland

Thomas.Pabst@insel.ch

+41 31 63 2 84 30

Study Officials

• Thomas Pabst, MD

  Department of Medical Oncology, University Hospital Bern

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 investigating the drugs bendamustine hydrochloride and melphalan.

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 14, 2017
• Study Start: July 20, 2017
• Primary Completion: March 12, 2020
• Study Completion: May 28, 2020
• Last Updated: January 30, 2025
• Results First Posted: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

CH (1)