High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma

Northside Hospital, Inc.

Status and phase

Completed

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: BeEAM

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02416206

NSH 1107

Details and patient eligibility

About

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.

Full description

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.

Enrollment

65 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.