- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01179490
Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma
A Multicenter, Open-Label, Phase 2 Study of SyB L-0501 (Bendamustine Hydrochloride) for Patients With Multiple Myeloma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Fukuoka, Japan
- Research Site
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Aichi
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Nagoya, Aichi, Japan
- Research Site
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Kanagawa
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Isehara, Kanagawa, Japan
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]
Time Frame: Up to 36 weeks
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The proportion of subjects evaluated as CR was calculated. CR (modified SWOG) requires all of the followings:
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Up to 36 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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CR Rate [Based on the International Myeloma Working Group (IMWG) Criteria]
Time Frame: Up to 36 weeks
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The proportion of subjects evaluated as CR [strict CR (sCR) + CR] was calculated. sCR (IMWG): CR as defined below plus Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence CR (IMWG): Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow |
Up to 36 weeks
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Response Rate (Based on the IMWG Criteria)
Time Frame: Up to 36 weeks
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The proportion of subjects evaluated as response [sCR + CR + very good partial response (VGPR) + Partial Response (PR)] was calculated. VGPR (IMWG): Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level <100mg per 24 h PR (IMWG): ≥50% reduction of serum M-protein and reduction in 24 h urinary M-protein by ≥90% or to <200mg per 24 h |
Up to 36 weeks
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CR Rate Based on the (Bladé) Criteria
Time Frame: Up to 36 weeks
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The proportion of subjects evaluated as CR was calculated. CR (Bladé) requires all of the followings:
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Up to 36 weeks
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Response Rate (Based on the Bladé Criteria)
Time Frame: Up to 36 weeks
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The proportion of subjects evaluated as response (CR + PR) was calculated. PR (Bladé) requires 1. or all of the others:
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Up to 36 weeks
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Response Rate (Based on the Modified SWOG Criteria)
Time Frame: Up to 36 weeks
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The proportion of subjects evaluated as response (CR + PR) was calculated. PR (SWOG) requires the followings:
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Up to 36 weeks
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Progression-Free Survival (PFS)
Time Frame: Up to 2 years
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PFS is the period from patient registration to either the date of recurrence, exacerbation, progression or death. Recurrence, exacerbation, progression were assessed from serum M-protein, urine M-protein, serum free light chain (FLC), the percentage of marrow plasma cells, disappearance of clonal plasma cells, plasma cell tumor in soft tissue, and bone lesion. |
Up to 2 years
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Time to Treatment Failure (TTF)
Time Frame: Up to 2 years
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TTF is the period from patient registration to either the date of recurrence, exacerbation, progression, death or discontinuation of treatment.
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Up to 2 years
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Duration of Response (DOR)
Time Frame: Up to 2 years
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DOR is the period from the date of achieving CR or PR to either the date of recurrence, exacerbation, progression or death.
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Up to 2 years
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Overall Survival (OS)
Time Frame: Up to 2 years
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OS is the period from the date of patient registration to the date of death.
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Up to 2 years
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Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event
Time Frame: Up to 2 years
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Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02,
Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).
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Up to 2 years
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Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events
Time Frame: Up to 2 years
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Adverse events were evaluated using Common Terminology Criteria for Adverse Events (CTCAE) v4.02,
Japan Clinical Oncology Group/Japan Society of Clinical Oncology (JCOG/JSCO) version, and were encoded using Medical Dictionary for Regulatory Activities (MedDRA).
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Up to 2 years
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Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Time Frame: Up to 2 years
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Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE. grade 1 : mild grade 2 : moderate grade 3 : severe or medically significant but not immediately life-threatening grade 4 : life threatening or disabling grade 5 : death related to AE |
Up to 2 years
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Number of Abnormalities (Grade ≥3) in Laboratory Test Values
Time Frame: Up to 2 years
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Abnormalities in laboratory test values in overall study period were analyzed.
Severity of abnormalities were evaluated using CTCAE.
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Up to 2 years
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Pharmacokinetic Parameters (Cmax)
Time Frame: On Day 1 only
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Plasma pharmacokinetics (Cmax) of unchanged bendamustine
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On Day 1 only
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Pharmacokinetic Parameters (Tmax)
Time Frame: On Day 1 only
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Plasma pharmacokinetics (tmax) of unchanged bendamustine
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On Day 1 only
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Pharmacokinetic Parameters (AUC)
Time Frame: On Day 1 only
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Plasma pharmacokinetics (AUC) of unchanged bendamustine
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On Day 1 only
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Pharmacokinetic Parameters (t1/2)
Time Frame: On Day 1 only
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Plasma pharmacokinetics (t1/2) of unchanged bendamustine
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On Day 1 only
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Shinsuke Iida, MD, Ph D, Nagoya City University Graduate School of Medical Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Prednisolone
Other Study ID Numbers
- 2010002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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