High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma
High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma
High-dose chemotherapy and autologous stem cell transplantation (ASCT) as part of the
 up-front treatment of patients with multiple myeloma has been associated with improved
 disease-free and overall survival in multiple large randomized controlled trials. Following
 3-6 cycles of standard induction therapy with biologic agents, consolidation with high dose
 Melphalan and ASCT has become the standard-of-care approach for fit myeloma patients up to 70
 years of age. Single-agent high-dose Melphalan (200mg/m2) is currently the standard-of-care
 preparative regimen prior to autologous transplant in Myeloma. Historical studies utilizing
 Busulfan- or Total Body Irradiation-based preparative regimens have yielded similar results
 to single-agent Melphalan with higher toxicity.
Myeloma patients, following up-front induction therapy, will receive an ASCT following a
 high-dose bendamustine-based preparative regimen (BeEAM). The primary endpoint of this trial
 will be the rate of CR at day 100 post-transplant. Experience from the literature, as well as
 results from our institution, suggests that following ASCT for the upfront treatment of
 myeloma, the rate of CR at day 100 post-transplant is approximately 45%. It is hoped that
 under this protocol, this rate will be at least 65%. Thus we statistically formalize this
 study by testing the null hypothesis that p, the CR rate is 0.65 or more versus the
 alternative hypothesis that p is less than 0.45. A sample size of 65 pts gives 90% power with
 an alpha=0.05, using the formula for a one sample binomial (two-sided) test of a proportion.
Inclusion Criteria:

 -  Age between 18 - 70 years

 -  Karnofsky status ≥ 70%

 -  Diagnosis of Multiple Myeloma

 -  Within 9 months of the start of induction chemotherapy and no evidence of relapse or
 progression.

 -  Availability of Cryopreserved peripheral blood stem cells with a CD34 dose of at least
 2x106/kg.

 Exclusion Criteria:

 -  Poor cardiac function: left ventricular ejection fraction <40%

 -  Poor pulmonary function: FEV1, FVC, or DLCO <40% predicted

 -  Poor liver function: bilirubin >2.5 mg/dl (not due to hemolysis, Gilbert's or primary
 malignancy), AST/ALT > 3X ULN

 -  Poor renal function: Creatinine >2.0 mg/dl or creatinine clearance < 40 mL/min
 (calculated creatinine clearance is permitted)

 -  Ongoing or active systemic infection, active hepatitis B or C virus infection, or
 known human immunodeficiency virus (HIV) positive.

 -  Women of childbearing potential who currently are pregnant or who are not practicing
 adequate contraception

 -  Patients who have any debilitating medical or psychiatric illness which would preclude
 their giving informed consent or their receiving optimal treatment and follow-up.