This multicenter, open-label, dose-escalating study will assess the safety and efficacy of DFRF4539A in patients with relapsed or refractory multiple myeloma. Cohorts of patients will receive multiple ascending doses of intravenous DFRF4539A every 3 weeks or weekly. Patients exhibiting acceptable safety and evidence of clinical benefit may receive DFRF4539A for up to 17 cycles. Anticipated time on study treatment is 1 year or until disease progression or unacceptable toxicity occurs.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
multiple ascending doses
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Duarte, California, United States
Unnamed facility
Jacksonville, Florida, United States
Unnamed facility
Sarasota, Florida, United States
Safety: Incidence of adverse events
Time frame: approximately 3.5 years
Safety: Maximum tolerated dose/dose-limiting toxicities
Time frame: approximately 1.5 years
Recommended Phase II dose for every-3-week or weekly administration of DFRF4539A
Time frame: approximately 3.5 years
Immunogenicity: Serum antitherapeutic antibody levels
Time frame: approximately 3.5 years
Pharmacokinetics: Area under the concentration - time curve (AUC)
Time frame: approximately 3.5 years
Objective response, tumor assessments according to International Myeloma Working Group (IMWG) Uniform Response Criteria and/or European Bone Marrow Transplant (EBMT) Criteria
Time frame: approximately 3.5 years
Duration of objective response, defined as time from first documented objective response to progression or death of any cause
Time frame: approximately 3.5 years
Progression-free survival, defined as time from first study treatment (Cycle 1, Day 1) to disease progression or death during study or within 30 days after last dose of study drug, whichever occurs first
Time frame: approximately 3.5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Bethesda, Maryland, United States
Unnamed facility
New York, New York, United States
Unnamed facility
Nashville, Tennessee, United States