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

SymBio Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Multiple Myeloma

Treatments: Drug: prednisolone; Drug: SyB L-0501

Study type: Interventional

Funder types: Industry

Identifiers

NCT01179490

2010002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 5 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

5 participants in 1 patient group

SyB L-0501 + prednisolone

Experimental group

Description:

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.

Treatment:

Drug: prednisolone

Drug: SyB L-0501