Busulfan and Melphalan Conditioning in Multiple Myeloma

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether intravenous busulfan and melphalan as a conditioning regimen is effective in the treatment of multiple myeloma undergoing autologous stem cell transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chonnam National University Hospital
• Collaborator: Korea Otsuka Pharmaceutical Co., Ltd.
• Treatments: Busulfan; Melphalan

Criteria

Inclusion Criteria:

• Patients with a confirmed diagnosis of MM

• Symptomatic MM

• Age 20 - 65 years

• The MM patients who performed the stem cell collection with appropriate stem cell counts, cluster of differentiation 34 positive cells more than 2 x 10^6 /kg

• Eastern Cooperative Oncology Group 0 - 2

• The MM patients who received induction chemotherapy regardless of types of induction

• Patient has measurable disease when the patients started the primary induction therapy, defined as follows: Measurable disease is defined as serum M-protein more than 1 g/dL, urine M-protein more than 200 mg/24 hours, or free light chain more than 100 mg/L

• Adequate liver functions before ASCT Transaminase less than 3 x upper normal value Bilirubin less than 2 x upper normal value

• Adequate hematological function - Platelet count more than 50,000 /microliter, hemoglobin more than 8 g / dL but, Prior red blood cell transfusion or recombinant human erythropoietin use is allowed, absolute neutrophil count more than 1,000 / microliter

• Expected survival: 6 months or more

• Informed consent

Exclusion Criteria:

• Systemic amyloid light chain amyloidosis, smoldering multiple myeloma or monoclonal gammopathy of undetermined significance

• Patient with plasma cell leukemia

• Patients who received an extensive radiation therapy within 4 weeks

• Patient is known to be Human Immunodeficiency Virus positive

• Patient has known clinically active Hepatitis B or C

• Pregnant or lactating women, women of childbearing potential not employing adequate contraception

• Other serious illness or medical conditions Uncontrolled or severe cardiovascular disease, including myocardial infarction, within 6 months of enrollment, New York Heart Association Class III or IV heart failure, uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis History of significant neurological or psychiatric disorders including dementia or seizures Active uncontrolled infection Active ulcers detected at gastroscopy Other serious medical illnesses

• Known hypersensitivity to any of the study drugs or its ingredients concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy