Multiple MyelomaPhase 2NCT01179490
Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma
A Phase 2 study testing SyB L-0501 and prednisolone in people with Multiple Myeloma, run by SymBio Pharmaceuticals at 3 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- SyB L-0501 and prednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 3 sitesJapan
- Study dates
- Sep 2010to Sep 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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 locations and contacts
3 sites in 1 country.
Japan3 sites
Research site
Fukuoka, Fukuoka
Research site
Isehara, Kanagawa
Research site
Nagoya, Aichi-ken
About this study
Official title: A Multicenter, Open-Label, Phase 2 Study of SyB L-0501 (Bendamustine Hydrochloride) for Patients With Multiple Myeloma
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- SyB L-0501, prednisolone
- Keywords
- Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyB L-0501Drug
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).
prednisoloneDrug
Prednisolone will be administered (60 mg/m2/day) orally for 4 consecutive days and the course will be observed for the next 24 days.
| Study group | Role | What they receive |
|---|---|---|
| SyB L-0501 + prednisolone | Experimental | 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. Receives: Drug: SyB L-0501; Drug: prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]
The proportion of subjects evaluated as CR was calculated.
CR (modified SWOG) requires all of the followings:
- Decline in serum myeloma protein by ≥75% to ≤25 g/L
- Reduction in 24 h urinary protein by ≥90% to ≤200 mg/24 h
- No increase in skeletal destruction
- Serum calcium within normal range
- No blood transfusion required in the previous 3 months
Measured: Up to 36 weeks
Secondary outcomes (17)
CR Rate [Based on the International Myeloma Working Group (IMWG) Criteria]
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
Measured: Up to 36 weeks
Response Rate (Based on the IMWG Criteria)
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
Measured: Up to 36 weeks
CR Rate Based on the (Bladé) Criteria
The proportion of subjects evaluated as CR was calculated.
CR (Bladé) requires all of the followings:
- Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks. The presence of oligoclonal bands consistent with oligoclonal immune reconstitution does not exclude CR.
- <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy, if biopsy is performed. If absence of monoclonal protein is sustained for 6 weeks it is not necessary to repeat the bone marrow, except in patients with non-secretory myeloma where the marrow examination must be repeated after an interval of at least 6 weeks to confirm CR.
- No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response)
- Disappearance of soft tissue plasmacytomas
Measured: Up to 36 weeks
Response Rate (Based on the Bladé Criteria)
The proportion of subjects evaluated as response (CR + PR) was calculated.
PR (Bladé) requires 1. or all of the others:
- Some, but not all, of the criteria for CR are fulfilled
- ≥50% reduction in the level of the serum monoclonal paraprotein, maintained for a minimum of 6 weeks.
- Reduction in 24 h urinary light chain excretion either by ≥90% or to <200 mg, maintained for a minimum of 6 weeks.
- For patients with non-secretory myeloma only, ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks.
- ≥50% reduction in the size of soft tissue plasmacytomas (by radiography or clinical examination).
- No increase in size or number of lytic bone lesions (development of a compression fracture does not exclude response).
Measured: Up to 36 weeks
Response Rate (Based on the Modified SWOG Criteria)
The proportion of subjects evaluated as response (CR + PR) was calculated.
PR (SWOG) requires the followings:
- Decline in myeloma protein of ≥25%-<74% in serum myeloma protein
- Reduction in 24h urinary myeloma protein of ≥25%-<89%
- No increase in skeletal destruction
- Serum calcium within normal range
Measured: Up to 36 weeks
Progression-Free Survival (PFS)
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.
Measured: Up to 2 years
Time to Treatment Failure (TTF)
TTF is the period from patient registration to either the date of recurrence, exacerbation, progression, death or discontinuation of treatment.
Measured: Up to 2 years
Duration of Response (DOR)
DOR is the period from the date of achieving CR or PR to either the date of recurrence, exacerbation, progression or death.
Measured: Up to 2 years
Overall Survival (OS)
OS is the period from the date of patient registration to the date of death.
Measured: Up to 2 years
Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event
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).
Measured: Up to 2 years
Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events
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).
Measured: Up to 2 years
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
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
Measured: Up to 2 years
Number of Abnormalities (Grade ≥3) in Laboratory Test Values
Abnormalities in laboratory test values in overall study period were analyzed. Severity of abnormalities were evaluated using CTCAE.
Measured: Up to 2 years
Pharmacokinetic Parameters (Cmax)
Plasma pharmacokinetics (Cmax) of unchanged bendamustine
Measured: On Day 1 only
Pharmacokinetic Parameters (Tmax)
Plasma pharmacokinetics (tmax) of unchanged bendamustine
Measured: On Day 1 only
Pharmacokinetic Parameters (AUC)
Plasma pharmacokinetics (AUC) of unchanged bendamustine
Measured: On Day 1 only
Pharmacokinetic Parameters (t1/2)
Plasma pharmacokinetics (t1/2) of unchanged bendamustine
Measured: On Day 1 only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- SymBio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shinsuke Iida, MD, Ph D, Study chair, Nagoya City University Graduate School of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179490
- Sponsor's protocol ID
- 2010002
- Status last verified
- Mar 2013
- First submitted
- 2 Aug 2010
- Last updated
- 18 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Phase 2 Study of SyB L-0501 (Bendamustine Hydrochloride) for Patients With Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01179490
- Acronym / sponsor ID
- 2010002
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- SymBio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Sep 2011 (actual)
- First posted
- 11 Aug 2010 (estimated)
- Results
- Posted 18 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SyB L-0501 + prednisolone | Experimental | Drug: SyB L-0501, Drug: prednisoloneSyB 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. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (21 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SyB L-0501SyB 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). | Drug | SyB L-0501 + prednisolone |
| prednisolonePrednisolone will be administered (60 mg/m2/day) orally for 4 consecutive days and the course will be observed for the next 24 days. | Drug | SyB L-0501 + prednisolone |
Primary outcome
Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]
Time frame: Up to 36 weeks
The proportion of subjects evaluated as CR was calculated. CR (modified SWOG) requires all of the followings: 1. Decline in serum myeloma protein by ≥75% to ≤25 g/L 2. Reduction in 24 h urinary protein by ≥90% to ≤200 mg/24 h 3. No increase in skeletal destruction 4. Serum calcium within normal range 5. No blood transfusion required in the previous 3 months
17 secondary outcomes
CR Rate [Based on the International Myeloma Working Group (IMWG) Criteria]
Time frame: Up to 36 weeks
Response Rate (Based on the IMWG Criteria)
Time frame: Up to 36 weeks
CR Rate Based on the (Bladé) Criteria
Time frame: Up to 36 weeks
Response Rate (Based on the Bladé Criteria)
Time frame: Up to 36 weeks
Response Rate (Based on the Modified SWOG Criteria)
Time frame: Up to 36 weeks
Progression-Free Survival (PFS)
Time frame: Up to 2 years
Time to Treatment Failure (TTF)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Number of Subjects With Adverse Event, Related Adverse Event, Serious Adverse Event, and Related Serious Adverse Event
Time frame: Up to 2 years
Number of Adverse Events, Related Adverse Events, Serious Adverse Events, and Related Serious Adverse Events
Time frame: Up to 2 years
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Time frame: Up to 2 years
Number of Abnormalities (Grade ≥3) in Laboratory Test Values
Time frame: Up to 2 years
Pharmacokinetic Parameters (Cmax)
Time frame: On Day 1 only
Pharmacokinetic Parameters (Tmax)
Time frame: On Day 1 only
Pharmacokinetic Parameters (AUC)
Time frame: On Day 1 only
Pharmacokinetic Parameters (t1/2)
Time frame: On Day 1 only
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shinsuke Iida, MD, Ph D study chair
Nagoya City University Graduate School of Medical Sciences
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SyB L-0501 and prednisolone in people with Multiple Myeloma, run by SymBio Pharmaceuticals at 3 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria] (time frame: Up to 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2013.