Not currently recruiting at UCSF
Dose-Escalation Study of BFCR4350A in Participants With Relapsed or Refractory Multiple Myeloma (R/R MM)
a study on Multiple Myeloma
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at San Francisco, California and other locations
- Dates
- study startedestimated completion
Description
Summary
This is a phase I, multicenter, open-label, dose-escalation study of BFCR4350A administered as a single agent by IV infusion to participants with relapsed or refractory multiple myeloma (R/R MM).
Official Title
An Open-Label, Multicenter, Phase I Trial Evaluating the Safety and Pharmacokinetics of Escalating Doses of BFCR4350A in Patients With Relapsed or Refractory Multiple Myeloma
Keywords
Multiple Myeloma Neoplasms, Plasma Cell BFCR4350A Tocilizumab
Eligibility
You can join if…
Open to people ages 18 years and up
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Participants must have relapsed or refractory (R/R) multiple myeloma (MM) for which no established therapy for MM is appropriate and available or be intolerant to those established therapies
- Adverse events from prior anti-cancer therapy resolved to Grade < or = 1, except any grade alopecia and/or peripheral sensory or motor neuropathy which must have resolved to Grade < or = 2
- Measurable disease defined by laboratory test results
- Female participants of childbearing age must agree to remain abstinent or use reliable contraceptive methods during the treatment period, and at least 3 months after last dose of study drug
- Male participants must agree to refrain from donating sperm, to abstain or use a condom during the treatment period, and at least 60 days after last dose of study drug
You CAN'T join if...
- Inability to comply with protocol-mandated hospitalization and activities restrictions
- Pregnant, lactating, or planning to become pregnant during the study and up to 3 months after last dose of study drug
- Prior use of any monoclonal antibody, radioimmunoconjugate, or antibody-drug conjugate as anti-cancer therapy within 4 weeks before first infusion
- Prior treatment with systemic immunotherapeutic agents within 12 weeks or 5 half-lives of the drug, whichever is shorter, before first infusion
- Prior treatment with chimeric antigen receptor (CAR) T-cell therapy within 12 weeks before first BFCR4350A infusion
- Known treatment-related, immune-mediated adverse events associated with prior immunotherapeutic agents
- Treatment with radiotherapy, any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first BFCR4350A infusion
- Autologous stem cell transplantation (SCT) within 100 days prior to first infusion
- Prior allogeneic SCT or solid organ transplantation
- Absolute plasma cell count exceeding 500/micro L or 5% of the peripheral blood white cells
- History of autoimmune disease or of confirmed progressive multifocal leukoencephalopathy
- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
- Patients with known history of amyloidosis (e.g., positive Congo Red stain or equivalent in tissue biopsy)
- Patients with lesions in proximity of vital organs that may develop sudden decompensation/deterioration in the setting of a tumor flare
- History of other malignancy that could affect compliance with the protocol or interpretation of results
- Current or past history of central nervous system (CNS) disease, or CNS involvement by MM
- Significant cardiovascular disease that may limit a patient's ability to adequately respond to a CRS event
- Symptomatic active pulmonary disease requiring supplemental oxygen
- Within 14 days prior to first BFCR4350A infusion: known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics within 4 weeks prior to first infusion
- Known or suspected chronic active Epstein-Barr virus (EBV) infection, acute or chronic hepatitis C virus (HCV) infection
- Positive serologic or polymerase chain reaction (PCR) test results for acute or chronic hepatitis B virus (HBV) infection
- Recent major surgery within 4 weeks prior to first infusion
- Human Immunodeficiency Virus (HIV) positive
- History of illicit drug or alcohol abuse within 12 months prior to screening
- Any medical condition or laboratory test abnormality that precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results
Locations
- University of California San Francisco
not yet accepting patients
San Francisco California 94117 United States - City of Hope
accepting new patients
Duarte California 91010 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Genentech, Inc.
- ID
- NCT03275103
- Phase
- Phase 1
- Study Type
- Interventional
- Last Updated