Overview

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