Clinical trial NCT01179490: Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma
Official title: A Multicenter, Open-Label, Phase 2 Study of SyB L-0501 (Bendamustine Hydrochloride) for Patients With Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Lead sponsor: SymBio Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]
timeFrame: Up to 36 weeks
Secondary outcomes:
measure: CR Rate [Based on the International Myeloma Working Group (IMWG) Criteria]
timeFrame: Up to 36 weeks
measure: Response Rate (Based on the IMWG Criteria)
timeFrame: Up to 36 weeks
measure: CR Rate Based on the (Bladé) Criteria
timeFrame: Up to 36 weeks
measure: Response Rate (Based on the Bladé Criteria)
timeFrame: Up to 36 weeks
measure: Response Rate (Based on the Modified SWOG Criteria)
timeFrame: Up to 36 weeks
measure: Progression-Free Survival (PFS)
timeFrame: Up to 2 years
measure: Time to Treatment Failure (TTF)
timeFrame: Up to 2 years
measure: Duration of Response (DOR)
timeFrame: Up to 2 years
measure: Overall Survival (OS)
timeFrame: Up to 2 years
measure: Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event
timeFrame: Up to 2 years
measure: Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events
timeFrame: Up to 2 years
measure: Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
timeFrame: Up to 2 years
measure: Number of Abnormalities (Grade ≥3) in Laboratory Test Values
timeFrame: Up to 2 years
measure: Pharmacokinetic Parameters (Cmax)
timeFrame: On Day 1 only
measure: Pharmacokinetic Parameters (Tmax)
timeFrame: On Day 1 only
measure: Pharmacokinetic Parameters (AUC)
timeFrame: On Day 1 only
measure: Pharmacokinetic Parameters (t1/2)
timeFrame: On Day 1 only
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Research site
state: Aichi
city: Isehara
country: Japan
facility: Research site
state: Kanagawa
city: Fukuoka
country: Japan
facility: Research site
Study officials:
affiliation: Nagoya City University Graduate School of Medical Sciences
name: Shinsuke Iida, MD, Ph D
role: STUDY_CHAIR
References: