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Bendamustine and Melphalan in Myeloma (BEB-2)

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ClinicalTrials.gov Identifier: NCT03187223
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : December 3, 2018
Sponsor:
Collaborator:
Mundipharma Medical Company
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Melphalan Drug: Bendamustine Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized prospective non-blinded clinical phase II trial investigating the drugs bendamustine hydrochloride and melphalan.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase II Trial Comparing Bendamustine and Melphalan With Melphalan Alone as Conditioning Regimen for Autologous Stem Cell Transplantation (ASCT) in Myeloma Patients
Actual Study Start Date : July 20, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : March 2021


Arm Intervention/treatment
Active Comparator: Arm A (Mel)
Melphalan 100mg/m2/day iv days -2 and -1
Drug: Melphalan
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.
Other Name: Alkeran

Experimental: Arm B (BenMel)
Melphalan 100mg/m2/day iv days -2 and -1 Bendamustine 200mg/m2/day iv days -4 and -3
Drug: Melphalan
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.
Other Name: Alkeran

Drug: Bendamustine
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.
Other Name: Ribumustin




Primary Outcome Measures :
  1. Complete Remission rate [ Time Frame: 60 days ]
    Number of Patient achieving complete remissions (CR1) at 60 days after ASCT


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 60 days ]
    Number of Patient experiencing toxicities/adverse events assessed according to the CTCAE 4.0 during the study period

  2. Hematologic engraftment after high-dose chemotherapy [ Time Frame: 30 days ]
    Number of Patient achieving hematologic engraftment after high-dose chemotherapy induced myelosuppression is defined as the first day of neutrophils rising again above 0.5 G/l, and of platelets rising again above 20 G/L in the absence of platelet transfusions in the previous 3 days.

  3. Overall Survival [ Time Frame: 24 months ]
    Overall survival is defined as the time from ASCT until death of any cause or date of last follow-up

  4. Quality of Life: EORTC Q30 questionnaire [ Time Frame: 60 days ]
    Assessment of quality of life prior to ASCT and 60 days thereafter. The EORTC Q30 questionnaire will be given to patients at screening and at the day 60 assessment.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.
  • Female patients of child-bearing potential must have a negative pregnancy test (urine or serum) within 14 days prior to study treatment, and they must implement adequate measures (hormonal treatment p.o. or i.m., intra uterine surgical devices, or latex condoms) to avoid pregnancy during study treatment and for additional 12 months.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187223


Contacts
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Contact: Thomas Pabst, MD +41 31 632 84 30 thomas.pabst@insel.ch

Locations
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Switzerland
Department for Medical Oncology University Hospital/Inselspital Recruiting
Berne, Switzerland, 3010
Principal Investigator: Thomas Pabst, Prof Dr med         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Mundipharma Medical Company
Investigators
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Study Chair: Thomas Pabst, MD Department of Medical Oncology, University Hospital Bern

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT03187223     History of Changes
Other Study ID Numbers: BEB-2 Trial
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University Hospital Inselspital, Berne:
Multiple Myeloma
Bendamustine
Melphalan
ASCT
Additional relevant MeSH terms:
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Bendamustine Hydrochloride
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Melphalan
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs