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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: SymBio Pharmaceuticals
• Treatments: Bendamustine Hydrochloride; Methylprednisolone; Methylprednisolone acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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