Clinical Trials /

A Study of Bendamustine, Melphalan (+/- Rituximab) Conditioning and Autologous Stem Cell Transplantation for Treatment of Multiple Myeloma and Relapsed/Refractory B-cell Lymphoma in Elderly Patients

NCT03352765

Description:

This study is testing a combination of chemo-immuno therapy called RBM. RBM consists of combination of drugs: rituximab, bendamustine, and melphalan followed by reinfusion of the participants own stem cells which is called autologous stem cell transplant (ASCT). Compared to the standard BEAM regimen, this RBM regimen may or may not be less effective in lymphoma, but will likely have fewer side effects.

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Multiple Myeloma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Study of Bendamustine, Melphalan (+/- Rituximab) Conditioning and Autologous Stem Cell Transplantation for Treatment of Multiple Myeloma and Relapsed/Refractory B-cell Lymphoma in Elderly Patients
  • Official Title: A Phase I/II Study of Bendamustine and Melphalan (+/- Rituximab) Conditioning and Autologous Stem Cell Transplantation for Treatment of Multiple Myeloma and Relapsed/Refractory B-cell Lymphoma in Elderly Patients

Clinical Trial IDs

  • ORG STUDY ID: 17-373
  • NCT ID: NCT03352765

Conditions

  • Lymphoma

Interventions

DrugSynonymsArms
rituximabrituximab, bendamustine & melphalan and ASCT
bendamustinerituximab, bendamustine & melphalan and ASCT
melphalanrituximab, bendamustine & melphalan and ASCT

Purpose

This study is testing a combination of chemo-immuno therapy called RBM. RBM consists of combination of drugs: rituximab, bendamustine, and melphalan followed by reinfusion of the participants own stem cells which is called autologous stem cell transplant (ASCT). Compared to the standard BEAM regimen, this RBM regimen may or may not be less effective in lymphoma, but will likely have fewer side effects.

Trial Arms

NameTypeDescriptionInterventions
rituximab, bendamustine & melphalan and ASCTExperimentalThis is a phase I/II study of rituximab, bendamustine and melphalan (RBM) conditioning followed by ASCT in elderly patients with B-cell NHL. Conditioning regimen consist of rituximab 375 mg/m2 on days -11 and -4, bendamustine 160 mg/m2 intravenously on days -3 and -2; melphalan 140 mg/m2 intravenously on day -1 before the reinfusion of autologous stem cells on day 0. The conditioning timeline can be modified if there are patient scheduling conflicts.
  • rituximab
  • bendamustine
  • melphalan

Eligibility Criteria

        Inclusion Criteria:

        Phase I eligibility:

          -  Any patient with multiple myeloma B-cell non-Hodgkin lymphoma would be eligible for
             phase I portion of the study.

        Phase II eligibility:

          -  Histologically confirmed diagnosis of multiple myeloma or rel/ref DLBCL, or diffuse
             large B cell lymphoma transformed from an indolent lymphoma Since the endpoint of the
             Phase I portion is safety, any patient with myeloma or B-cell NHL can be enrolled. For
             phase II study patients with myeloma and B-NHL will be analyzed separately. The PFS
             endpoint varies greatly amongst different types of lymphoma. In order to accurately
             interpret the survival data, a homogeneous cohort of patients with DLBCL will be
             evaluated. DLBCL is the most aggressive B-NHL with limited options. Other B-NHL's are
             generally more indolent and have more options available to them.

        Additional eligibility for both the phase I and phase II studies:

          -  Patients between the ages of 65 to 69 years old with a Hematopoietic Stem Cell
             Transplant Comorbidity Index (HCT-CI) score of 3 or higher.

          -  Any patient age 70 years old or older, irrespective of their Hematopoietic Stem Cell
             Transplant Comorbidity Index (HCT-CI) score.

          -  KPS ≥ 70

          -  Males must agree to use an acceptable form of contraception per institutional
             practices.

          -  Complete or partial response to salvage chemotherapy by IWG Working Group Criteria

          -  Cardiac ejection fraction of ≥ 45%

          -  Hemoglobin-adjusted diffusing capacity of carbon monoxide (DLCO) of ≥45%

          -  Creatinine clearance of ≥50 mL/min

          -  Completion of most recent salvage therapy within 8 weeks of enrollment

          -  Direct bilirubin ≤2.0 mg/dL in the absence of suspected Gilbert's disease (if
             Gilbert's disease is suspected, the total bilirubin must be ≤3.0 mg/dL), and AST ≤ 2.5
             ULN.

        Exclusion Criteria:

          -  In Lymphoma: Disease progression by IWG Working Group Criteria since last therapy

          -  Patients with history of CNS involvement

          -  Prior autologous (only in lymphoma) or allogeneic stem cell transplantation

          -  Patients who have failed bendamustine-based regimen previously

          -  Patients within 6 months of MI and stroke will be excluded
      
Maximum Eligible Age:N/A
Minimum Eligible Age:65 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose limiting toxicities (DLT)
Time Frame:1 year
Safety Issue:
Description:are defined as grade > 3, non-hematologic toxicity related to treatment excluding grade 3 nausea or vomiting responsive to anti-emetic treatment, grade 3 diarrhea responding to anti-diarrheal treatment, grade 3 fatigue, grade 3 skin rash responsive to topical or systemic steroids, grade 3 fevers (> 40 degrees Celsius for < 24 hours) and alopecia per CTCAE

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Memorial Sloan Kettering Cancer Center

Trial Keywords

  • Rituximab
  • Bendamustine
  • Melphalan
  • Autologous Stem Cell Transplantation (ASCT)
  • 17-373

Last Updated

December 3, 2019