Phase II Study of V-BEAM Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation
|Conditions:||Blood Cancer, Hematology|
|Therapuetic Areas:||Hematology, Oncology|
|Age Range:||18 - Any|
|Start Date:||September 2012|
|End Date:||October 2017|
|Contact:||Ravi Vij, M.D.|
A Phase II Study of V-BEAM (Bortezomib, Carmustine, Etoposide, Cytarabine, and Melphalan) as Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation for Multiple Myeloma
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.
- Patient must have a histologically confirmed diagnosis of multiple myeloma.
- Patient must have received a prior autologous stem cell transplantation with
melphalan conditioning for multiple myeloma with subsequent disease progression and
repeat autologous stem cell transplantation is deemed appropriate by the treating
- Patient must receive induction chemotherapy including 2 to 4 cycles of anti-myeloma
therapy including bortezomib, with or without immune modulating agents and/or
corticosteroids, Completion of induction therapy will occur within 30 days of first
study drug dose.
- Patient must have ≥ 2x106/kg CD34+ autologous stem cells available for
- Patient must be ≥ 18 years of age.
- Patient must have life expectancy of greater than 6 months.
- Patient must have an ECOG performance status ≤ 2 or Karnofsky performance status ≥
60% (see Appendices A and B)
- Patient must have normal bone marrow and organ function as defined below within 14
days prior to first study drug dose (conditioning regimen):
- Absolute neutrophil count ≥500/mm3
- Platelets ≥ 50,000/mm3
- Hemoglobin ≥ 8 g/dl
- Total bilirubin ≤ 1.5 x IULN
- AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
- Creatinine clearance (Appendix C) ≥30 mL/min/1.73m2
- Women of childbearing potential and men must agree to use adequate contraception
(hormonal or barrier method of birth control, abstinence) prior to study entry
through Day +100 visit. Should a woman become pregnant or suspect she is pregnant
while participating in this study, she must inform her treating physician
- Patient must be able to understand and willing to sign an IRB approved written
informed consent document.
- Patient must not be refractory to induction therapy. Refractory is defined as disease
progression while on therapy or within 30 days following completion of therapy.
- Patient must not have had disease progression requiring active treatment within 12
months of previous autologous stem cell transplant. Maintenance therapy is not
considered active treatment.
- Patient must not have peripheral neuropathy ≥ grade 3 based on NCI CTCAE v 4.0
- Patient must not be receiving renal replacement therapy, hemodialysis, or peritoneal
- Patient must not have another concurrent malignancy requiring treatment.
- Patient must not be receiving any other investigational agents within 14 days prior
to the first dose of study drug.
- Patient must not have known brain metastases. Patients with known brain metastases
must be excluded from this clinical trial because of their poor prognosis and because
they often develop progressive neurologic dysfunction that would confound the
evaluation of neurologic and other adverse events.
- Patient must not have a history of allergic reactions attributed to compounds of
similar chemical or biologic composition to bortezomib, carmustine, etoposide,
cytarabine, and melphalan, or other agents used in the study.
- Patient must not have an uncontrolled intercurrent illness including, but not limited
to, ongoing or active infection, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that
would limit compliance with study requirements.
- Patient must not be pregnant and/or breastfeeding.
Inclusion of Women and Minorities
-Both men and women and members of all races and ethnic groups are eligible for this
We found this trial at
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
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