Atlanta, Georgia 30342


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT02416206


Primary Contact:

Principal Investigator
Scott R Solomon, MD
Northside Hospital

Scott R Solomon, MD
Phone: 404-255-1930
Email: ssolomon@bmtga.com


Backup Contact:

Email: stacey.brown@northside.com
Stacey L Brown, BA
Phone: 404-851-8238


Location Contact:

Atlanta, Georgia 30342
United States

Scott R. Solomon, MD
Phone: 404-255-1930

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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