Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Intervention: SyB L-0501; prednisolone
Intervention 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 will be administered (60 mg/m2/day) orally for 4 consecutive days and the course will be observed for the next 24 days.
Intervention MeSH terms: Prednisolone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No
Keywords: Multiple Myeloma

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.
    

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