Efficacy and Safety Study of SyB L-0501 for Patients With Multiple Myeloma

NCT01179490 | Terminated Phase 2 Results DMC

• 1 other identifier: 2010002
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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: 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

  Up to 36 weeks

Secondary Outcomes (17)

• CR Rate [Based on the International Myeloma Working Group (IMWG) Criteria]

  Up to 36 weeks

• Response Rate (Based on the IMWG Criteria)

  Up to 36 weeks

• CR Rate Based on the (Bladé) Criteria

  Up to 36 weeks

• Response Rate (Based on the Bladé Criteria)

  Up to 36 weeks

• Response Rate (Based on the Modified SWOG Criteria)

  Up to 36 weeks

Study Arms (1)

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.

Drug: SyB L-0501; Drug: prednisolone

Interventions

SyB L-0501 DRUG

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).

SyB L-0501 + prednisolone

prednisolone DRUG

Prednisolone will be administered (60 mg/m2/day) orally for 4 consecutive days and the course will be observed for the next 24 days.

SyB L-0501 + prednisolone

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SymBio Pharmaceuticals: lead

Study Sites (3)

Research site

Nagoya, Aichi-ken, Japan

Location

Research site

Fukuoka, Fukuoka, Japan

Location

Research site

Isehara, Kanagawa, Japan

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Toshihiko Nagase
• Organization: Symbio Pharmaceuticals

tnagase.331@symbiopharma.com

81-3-5472-1127

Study Officials

• Shinsuke Iida, MD, Ph D

  Nagoya City University Graduate School of Medical Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2010
• First Posted: August 11, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Last Updated: March 18, 2013
• Results First Posted: March 18, 2013

Record last verified: 2013-03

Locations

JP (3)