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.

SparkCures ID	874
Trial Phase	Phase 2
Enrollment	65 Patients
Treatments	Autologous Stem Cell Transplant Bendamustine Cytarabine Etoposide Melphalan
Trial Sponsors	Northside Hospital (Atlanta)
Trial Collaborators	Teva Pharmaceuticals
NCT Identifier	NCT02416206

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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.

High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma

Overview

Am I Eligible?

US Trial Locations