Clinical trial · Interventional
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
NCT01179490CI-TRIAL-00009745terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| prednisolone | Drug | Prednisolone | ALIAS |
| SyB L-0501 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SyB L-0501 + prednisolone
- 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 (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
- interventionNames
- Drug: SyB L-0501
- Drug: prednisolone
Primary outcomes (1)
- measure
- Complete Response (CR) Rate [Based on the Modified Southwest Oncology Group (SWOG) Criteria]
- timeFrame
- Up to 36 weeks
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.