BEAM regimen (BCNU, etoposide, cytarabine, and melphalan) is the most commonly used conditioning regimen for relapsed/refractory lymphoma patients needing autologous stem cell transplantation. Since these components are all effective in myeloma and bortezomib has shown promising results in the transplant setting, here the investigators propose a phase II study to investigate the combination of bortezomib and BEAM as a new conditioning regimen for patients who relapse or progress after the first autologous transplantation and for whom a second autologous transplant is considered.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Washington University School of Medicine
St Louis, Missouri, United States
Complete Response Rate (Complete Response + Stringent Complete Response)
Defined by the International Myeloma Working Group (IMWG) criteria
Time frame: Day +100
Number of Participants With Progression-free Survival (PFS)
PFS is defined as the duration from transplant to time of first progression, death, relapse after CR, or the date the patient was last known to be in remission. Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.
Time frame: Median follow-up of 6 months (range: 6.0-12.0 months)
Overall Response Rate (ORR)
ORR includes Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR) Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.
Time frame: 3 months following Day +100 visit
Very Good Partial Response Rate (VGPR+nCR+sCR+CR)
Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.
Time frame: Day +100
Toxicity of V-BEAM
Graded per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100. This outcomes measures the common toxicities observed. Please refer to the Serious Adverse Event and Other Adverse Event sections of the results for further details.
Time frame: 30 days after end of treatment / Day +100
Time to Neutrophil Engraftment After V-BEAM.
Time to neutrophil engraftment is defined as duration between Day 0 to the first day of ANC \> 0.5x109/L post transplant when it is sustained for more than three consecutive days.
Time frame: Day +100
Number of Participants With Overall Survival (OS)
OS is defined as the duration from the time of transplant to death or last follow-up.
Time frame: Median follow-up of 6 months (range: 6-12 months)
Treatment Related Mortality (TRM) of V-BEAM
Time frame: Day +100
Time to Platelet Engraftment After V-BEAM.
Time to platelet engraftment is defined as the duration between Day 0 to the first day of platelet count sustained at \> 20x109/L without transfusion. The median time to neutrophil and platelet engraftment will be reported.
Time frame: Day +100
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.