Overview

High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma

Status:
Completed
Trial end date:
2021-04-21
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Northside Hospital, Inc.
Collaborator:
Teva Pharmaceuticals USA
Treatments:
Melphalan
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.