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.