Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma

A Multicenter, Open-Label, Phase 2 Study of SyB L-0501 (Bendamustine Hydrochloride) for Patients With Multiple Myeloma

The study objectives of this study are to determine the effects, safety, and pharmacokinetics of bendamustine for multiple myeloma to a regimen of bendamustine and prednisolone.

The study objectives of this study are to determine the effects, safety, and pharmacokinetics of bendamustine for untreated and maladjustment to hematopoietic stem cell transplantation (HSCT) multiple myeloma to a regimen of bendamustine and prednisolone.

Inclusion Criteria:

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, liver, kidneys,)
• Patients from whom written consent to participate in this study has been obtained.

Exclusion Criteria:

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 insulin administration)
• 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 coagulation (DIC)]
• 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 nervous system.
• 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 pregnant
• 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 investigational drug
• Patients whom the investigator or the sub-investigators considered to be inappropriate for the study