Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma
Multiple Myeloma
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma
Eligibility Criteria
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
Sites / Locations
- Research site
- Research site
- Research site
Arms of the Study
Arm 1
Experimental
SyB L-0501 + prednisolone
SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.