Study of SyB L-0501 to Treat Relapsed/Refractory Multiple Myeloma

NCT01849848 | Completed Phase 2 Results

• 1 other identifier: 2011004
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Relapsed/Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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

  up to around 44 weeks

Secondary Outcomes (10)

• Response Rate (sCR+CR) Based on IMWG Criteria

  up to around 44 weeks

• Complete Response (CR) Based on the Blade Criteria

  up to around 44 weeks

• Response Rate (CR+PR) Based on the Blade Criteria

  up to around 44 weeks

• Progression-Free Survival (PFS)

  up to around 44 weeks

• Time to Treatment Failure (TTF)

  up to around 44 weeks

Study Arms (1)

SyB L-0501

EXPERIMENTAL

Drug: SyB L-0501

Interventions

SyB L-0501 DRUG

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.

SyB L-0501

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• % 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)
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• SymBio Pharmaceuticals: lead

Study Sites (14)

Unknown Facility

Chūōku, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Isehara, Japan

Location

Unknown Facility

Kōtoku, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Nagoya, Japan

Location

Unknown Facility

Niigata, Japan

Location

Unknown Facility

Okayama, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Sendai, Japan

Location

Unknown Facility

Shibukawa, Japan

Location

Unknown Facility

Shibuya-ku, Japan

Location

Unknown Facility

Tokushima, Japan

Location

Unknown Facility

Utsunomiya, Japan

Location

MeSH Terms

Conditions

Multiple Myeloma

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

Results Point of Contact

• Title: Toshihiko Nagase
• Organization: SymBio Pharmaceuticals

+81-3-5472-1127

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: April 17, 2013
• First Posted: May 9, 2013
• Study Start: November 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: February 6, 2015
• Results First Posted: January 9, 2015

Record last verified: 2015-01

Locations

JP (14)