A Multicenter, Open-Label, Phase 2 Study of SyB L-0501 (Bendamustine Hydrochloride) for Patients With Multiple Myeloma
Patients are included in the study if all of the following criteria are met: Patients
confirmed to have multiple myeloma (symptomatic myeloma) defined in the diagnostic
criteria of the International Myeloma Working Group (IMWG).
- Patients with measurable lesions
- Patients with no history of treatment (no history of chemotherapy or radiotherapy)
- Patients should not be considered candidates for high dose therapy/autologous stem
cell transplantation due to coexistent medical conditions, advanced age, poor
performance status, refusal of high dose chemotherapy, or other reasons as judged by
the patient and/or physician.
- Expected survival of at least 3 months
- Patients aged between 20 and 79 years (at the time of provisional registration)
- Performance status (P.S.) grade 0-2. P.S. 3 possible only for osteolytic lesions
- Patients with adequately maintained organ function (e.g., bone marrow, heart, lungs,
- Patients from whom written consent to participate in this study has been obtained.
Patients are excluded from participating in the study if 1 or more of the following
criteria are met:
- Patients with apparent infections (including viral infections)
- Patients with serious complications (hepatic failure, renal failure, or diabetes with
- Patients with complications or a medical history of serious cardiac disease (e.g.,
myocardial infarction, ischemic heart disease) within 2 years before preliminary
registration. Patients with arrhythmia requiring treatment.
- Patients with serious gastrointestinal symptoms (profound or serious nausea /
vomiting or diarrhea, etc.)
- Patients who were hepatitis B virus antigen (HBsAG)-positive, hepatitis C virus (HCV)
antibody-positive or human immunodeficiency virus (HIV) antibody-positive
- Patients with a serious bleeding tendency [e.g., Disseminated intravascular
- Patients with interstitial pneumonia, pulmonary fibrosis or pulmonary emphysema
requiring treatment, or such diseases in the past
- Patients with apparent amyloidosis as a complication
- Patients with clinical symptoms of invasion or suspected invasion of the central
- Patients with active multiple cancers
- Patients who have or previously had autoimmune hemolytic anemia.
- Patients administered this investigational drug in the past
- Patients who received hematopoietic stem cell transplantation in the past.
- Patients who received cytokines such as granulocyte colony stimulating factor (G-CSF)
or erythropoietin or a blood transfusion within 1 week before the screening
examination prior to preliminary registration for this study
- Patients who were administered an investigational drug during a clinical study or an
unapproved drug within 3 months prior to preliminary registration in this study
- Patients with prior allergies to medications similar to the investigational drug
(e.g., alkylating agents, or purine nucleotide analogs), mannitol or prednisolone
- Patients with drug addiction, narcotic addiction or alcoholism.
- Patients who were pregnant, breastfeeding women or who had a possibility to be
- Patients who do not agree to contraception during the following periods. For males,
during or for 6 months after completion of administration of the investigational
drug. For females, during or for 3 months after completion of administration of the
- Patients whom the investigator or the sub-investigators considered to be
inappropriate for the study