Relapsed/Refractory Multiple MyelomaPhase 2NCT01849848
Study of SyB L-0501 to Treat Relapsed/Refractory Multiple Myeloma
A Phase 2 study testing SyB L-0501 in people with Relapsed/Refractory Multiple Myeloma, run by SymBio Pharmaceuticals at 14 sites in Japan.
Trial summary
The purpose of this study is to determine the antitumor efficacy and safety of bendamustine (SyB L-0501: 90 mg/m^2/day) for a maximum of 6 cycles (1 cycle: intravenous administration for 2 consecutive days and 26-day observation period) in patients with relapsed/refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Relapsed/Refractory Multiple Myeloma
- What is being tested?
- SyB L-0501
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 14 sitesJapan
- Study dates
- Nov 2011to Jul 2013
- 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
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed with multiple myeloma on the basis of the response criteria of the International Myeloma Working Group (IMWG) and confirmed to meet one or more of the following criteria:
- (definition of progression according to the IMWG response criteria)
- 25% or more increase compared to baseline for the following values
- Serum M-protein level (however, the absolute value is 0.5 g/dL or higher)
- Urine M-protein level (however, absolute value is 200 mg/24 hours or higher)
- For lesions without measurable serum or urine M-protein values. involved/uninvolved free light chain (FLC) ratio (however, absolute value is 10 mg/dL or higher)
Show all 32Show fewer
- Clear appearance of new bone lesions or soft tissue plasmacytoma or apparent growth in size of current bone lesions or soft tissue plasmacytoma
- Appearance of hypercalcemia (corrected calcium level ≥ 11.5 mg/dL and if determined to be caused solely by myelomas)
- Patients with measurable lesions (meets at least one of the following two criteria
- Serum M-protein [Immunoglobulin G (IgG)≥ 1.0 g/dL, Immunoglobulin A (IgA) ≥ 0.5 g/dL, Immunoglobulin D (IgD) ≥ 0.1 g/dL)
- Urine M-protein ≥ 200 mg/24 hours
- Patients who meet either one of the following items for all prior chemotherapy using proteasome inhibitors, Immunomodulatory Drugs (IMiDs) (thalidomide or lenalidomide) or alkylating agents.
- No response*
- Relapse/recurrence after response*
- Intolerance
- Not applicable (reason can be confirmed in the source document) because of predicted aggravation of complications (neurotoxicity, etc.) * Patients whose disease has progressed based on the IMWG response criteria after receiving the most recent therapy
- Patients who have undergone a washout period of more than 3 weeks after the end of the previous therapy and determined not to be under the effect of previous treatment (antitumor effectiveness).
- Patients who are expected to survive for at least 3 months
- Patients aged from 20 to 79 years at the time of interim registration
- Performance Status (P.S.) of 0 to 125. However, P.S. 2 due to pain from lytic bone lesions is acceptable
- Patients with adequately maintained organ functions (e.g., bone marrow, heart, lung, liver, and kidney functions)
- Neutrophil count:≥ 1,500 /mm^3
- Platelet count:≥ 75,000 /mm^3
- Albumin:≥ 2.5 g /dL
- Aspartate aminotransferase (AST) Glutamic oxaloacetic transaminase (GOT): < than 3.0 times the upper limit of normal range for the site
- Alanine aminotransferase (ALT) Glutamic pyruvic transaminase (GPT): < than 3.0 times the upper limit of normal range for the site
- Total bilirubin: < than 1.5 times the upper limit of normal range for the site
- Serum creatinine: < than 3.0 times the upper limit of normal range for the site
- Partial pressure of O2 (PaO2) ≥ 65 mmHg
- No abnormalities which require treatment are detected on ECG
- Left ventricular ejection fraction (LVEF)(echocardiography): ≥ 55%
- Patients who have provided written consent for participation in this study
Who cannot join
- Patients with apparent infections (including viral infections)
- Patients with serious complications (hepatic or renal dysfunction, etc.)
- Patients with complications or medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease) within 2 years of the date of interim registration or patients with arrhythmias that require treatment
- Patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or diarrhea)
- Patients positive for Hepatitis B surface (HBs) antigen, Hepatitis C virus (HCV) antibody, or HIV antibody
- Patients with serious bleeding tendencies (e.g., disseminated intravascular coagulation: DIC)
Show all 21Show fewer
- Patients with, or confirmed in the past to have had, interstitial pneumonia, pulmonary fibrosis, or pulmonary emphysema which requires treatment.
- Patients with a complication of apparent cardiac amyloidosis
- Patients with infiltration to the central nervous system (CNS) or patients with clinical symptoms of suspected infiltration to the CNS,
- Patients with active multiple primary cancer
- Patients with, or confirmed in the past to have had, autoimmune hemolytic anemia
- Patients who have received this investigational product in the past
- Patients who have received allogeneic stem cell transplants in the past. (patients who have received autologous stem cell transplantation are acceptable)
- Patients who received cytokine preparations such as erythropoietin or granulocyte colony stimulating factor (G-CSF) or blood transfusions within 1 week prior to the examination conducted before interim registration for this study
- Patients who received other investigational products or unapproved medications within 3 months before interim registration for this study
- Patients with prior allergies to medications that are similar to this investigational product (e.g., alkylating agents, or purine-nucleoside derivatives) or mannitol
- Patients with drug addiction, narcotics addiction, and/or alcohol dependency
- Patients who are pregnant, who may possibly be pregnant, or lactating
- Patients who do not agree to practice contraception for the following periods:
- Male: During investigational product administration and until 6 months after final administration Female: During investigational product administration and until 4 months after final administration
- Patients otherwise judged by the investigator or sub-investigator to be unsuitable for inclusion in this study
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Japan14 sites
Study site
Chūōku
Study site
Fukuoka
Study site
Isehara
Study site
Kōtoku
Study site
Kyoto
Study site
Nagoya
Study site
Niigata
Study site
Okayama
Study site
Sapporo
Study site
Sendai
Study site
Shibukawa
Study site
Shibuya-ku
Study site
Tokushima
Study site
Utsunomiya
About this study
Official title: A Multicenter, Open-Label Phase II Study of SyB L-0501 in Patients With Relapsed/Refractory Multiple Myeloma
The purpose of this study is to determine the antitumor efficacy and safety of bendamustine (SyB L-0501: 90 mg/m^2/day) for a maximum of 6 cycles (1 cycle: intravenous administration for 2 consecutive days and 26-day observation period) in patients with relapsed/refractory multiple myeloma.
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Being tested
- SyB L-0501
- 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
The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
| Study group | Role | What they receive |
|---|---|---|
| SyB L-0501 | Experimental | Not described Receives: Drug: SyB L-0501 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria
The criteria for sCR, CR, VGPR, and PR based on IMWG are shown below.
sCR: Fulfills CR criteria as well as all of the following conditions
- Normal free light chain (FLC) ratio(κ/λ)
- Disappearance of clonal cells in bone marrow by immunohistochemistry or immunofluorescence
CR: Fulfills all of the following criteria
- Negative immunofixation of serum and urine M-protein
- <5% plasma cells in bone marrow
- Disappearance of any soft tissue plasmacytoma
VGPR: Fulfills at least one of the following criteria
- Serum and urine M-protein detectable by immunofixation but not electrophoresis
- ≥90% reduction in serum M-protein and 24-hour M-protein excretion amount in urine <0.1 g/24 hour
PR: Fulfills the following criteria
- ≥50% reduction in serum M-protein, and ≥90% reduction in urine M-protein, urine M-protein excretion amount is reduced to < 0.2 g/24hours
Measured: up to around 44 weeks
Secondary outcomes (10)
Response Rate (sCR+CR) Based on IMWG Criteria
Measured: up to around 44 weeks
Complete Response (CR) Based on the Blade Criteria
The criteria for CR based on the Blade are shown below.
CR requires all of the followings:
- Absence of the original monoclonal paraprotein in serum and urine by immunofixation, maintained for a minimum of 6 weeks
- <5% plasma cells in a bone marrow aspirate and also on trephine bone biopsy
- No increase in size or number of lytic bone lesions
- Disappearance of soft tissue plasmacytomas
Measured: up to around 44 weeks
Response Rate (CR+PR) Based on the Blade Criteria
The criteria for PR based on the Blade are shown below.
PR 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
- ≥50% reduction in the size of soft tissue plasmacytomas
- No increase in size or number of lytic bone lesions
Measured: up to around 44 weeks
Progression-Free Survival (PFS)
Using the registration date as the start date, PFS with relapse/recurrence or progression, and death regardless of the cause as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and the 95% confidence interval are to be calculated.
Measured: up to around 44 weeks
Time to Treatment Failure (TTF)
Using the registration date as the start date, TTF with relapse/recurrence or progression, death regardless of the cause, and early discontinuation of treatment as events are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.
Measured: up to around 44 weeks
Duration of Response (DOR)
From initial response (PR or higher), DOR with relapse/recurrence or progression, and death, regardless of cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.
Measured: up to around 44 weeks
Overall Survival (OS)
Using the registration date as the start date, OS with death, regardless of the cause, as events, are to be summarized using the Kaplan-Meier estimator and the 50% point according to the Greenwood's formula and 95% confidence interval are to be calculated.
Measured: up to around 44 weeks
Adverse Events
All adverse events occurring during the administration of the investigational product are to be examined for safety by cross tabulation lists and tables of incidence from the viewpoint of relationship with the drug, disease severity and medicine treated group.
Measured: up to around 44 weeks
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 Common Terminology Criteria for Adverse Events (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 adverse event
Measured: up to around 44 weeks
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 Common Terminology Criteria for Adverse Events (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 adverse event
Measured: up to around 44 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2013 (estimated)
- Study startNov 2011
- Primary completionJul 2013
- Study completionJul 2013
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 Relapsed/Refractory 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
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- SymBio Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849848
- Sponsor's protocol ID
- 2011004
- Status last verified
- Jan 2015
- First submitted
- 17 Apr 2013
- Last updated
- 6 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Phase II Study of SyB L-0501 in Patients With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT01849848
- Acronym / sponsor ID
- 2011004
- Conditions
- Relapsed/Refractory Multiple Myeloma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- SymBio PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 9 May 2013 (estimated)
- Results
- Posted 9 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the antitumor efficacy and safety of bendamustine (SyB L-0501: 90 mg/m^2/day) for a maximum of 6 cycles (1 cycle: intravenous administration for 2 consecutive days and 26-day observation period) in patients with relapsed/refractory multiple myeloma.
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 | Experimental | Drug: SyB L-0501 |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Patients who are diagnosed with multiple myeloma on the basis of the response criteria of the International Myeloma Working Group (IMWG) and confirmed to meet one or more of the following criteria:
- (definition of progression according to the IMWG response criteria)
- Patients with measurable lesions (meets at least one of the following two criteria
- Patients who meet either one of the following items for all prior chemotherapy using proteasome inhibitors, Immunomodulatory Drugs (IMiDs) (thalidomide or lenalidomide) or alkylating agents.
- Patients who have undergone a washout period of more than 3 weeks after the end of the previous therapy and determined not to be under the effect of previous treatment (antitumor effectiveness).
Key exclusion criteria (21 listed)
- Patients with apparent infections (including viral infections)
- Patients with serious complications (hepatic or renal dysfunction, etc.)
- Patients with complications or medical history of serious cardiac disease (e.g., myocardial infarction, ischemic heart disease) within 2 years of the date of interim registration or patients with arrhythmias that require treatment
- Patients with serious gastrointestinal symptoms (e.g., severe nausea, vomiting, or diarrhea)
- Patients positive for Hepatitis B surface (HBs) antigen, Hepatitis C virus (HCV) antibody, or HIV antibody
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-0501The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle. | Drug | SyB L-0501 |
Primary outcome
Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria
Time frame: up to around 44 weeks
The criteria for sCR, CR, VGPR, and PR based on IMWG are shown below. sCR: Fulfills CR criteria as well as all of the following conditions * Normal free light chain (FLC) ratio(κ/λ) * Disappearance of clonal cells in bone marrow by immunohistochemistry or immunofluorescence CR: Fulfills all of the following criteria * Negative immunofixation of serum and urine M-protein * <5% plasma cells in bone marrow * Disappearance of any soft tissue plasmacytoma VGPR: Fulfills at least one of the following criteria * Serum and urine M-protein detectable by immunofixation but not electrophoresis * ≥90% reduction in serum M-protein and 24-hour M-protein excretion amount in urine <0.1 g/24 hour PR: Fulfills the following criteria * ≥50% reduction in serum M-protein, and ≥90% reduction in urine M-protein, urine M-protein excretion amount is reduced to < 0.2 g/24hours
10 secondary outcomes
Response Rate (sCR+CR) Based on IMWG Criteria
Time frame: up to around 44 weeks
Complete Response (CR) Based on the Blade Criteria
Time frame: up to around 44 weeks
Response Rate (CR+PR) Based on the Blade Criteria
Time frame: up to around 44 weeks
Progression-Free Survival (PFS)
Time frame: up to around 44 weeks
Time to Treatment Failure (TTF)
Time frame: up to around 44 weeks
Duration of Response (DOR)
Time frame: up to around 44 weeks
Overall Survival (OS)
Time frame: up to around 44 weeks
Adverse Events
Time frame: up to around 44 weeks
Number of Subjects With Abnormality (Grade ≥3) in Laboratory Test Values
Time frame: up to around 44 weeks
Number of Abnormalities (Grade ≥3) in Laboratory Test Values
Time frame: up to around 44 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2015.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
14 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 in people with Relapsed/Refractory Multiple Myeloma, run by SymBio Pharmaceuticals at 14 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 32 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: finished, as of the sponsor's last update on 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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 9 Jan 2015). 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?
Response Rate [Stringent CR (sCR)+Complete Response (CR)+Very Good PR (VGPR)+Partial Response (PR)]Based on International Myeloma Working Group (IMWG) Criteria (time frame: up to around 44 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 6 Feb 2015.