A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma

Study Overview
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Brief Summary
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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.

Official Title
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An Open-label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Drug: DFRF4539A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients; >/= 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 Relapsed or refractory multiple myeloma for which no effective standard therapy exists One of the prior therapies must have included a proteosome inhibitor or an immunomodulatory drug Measurable disease as defined by protocol Exclusion Criteria: Prior use of monoclonal antibody within 4 weeks before Cycle 1, Day 1 Treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any investigational anti-cancer agent within 2 weeks prior to Cycle 1, Day 1 Toxicities from any previous treatment must be resolved prior to Cycle 1, Day 1, except for neuropathy Completion of autologous stem cell transplant within 100 days prior to Cycle 1, Day 1 Prior allogeneic stem cell transplant History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) Grade > 1 peripheral neuropathy Active infection at screening or any major episode of infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to Cycle 1, Day 1 Positive for hepatitis B, hepatitis C or HIV infection Pregnant or lactating women or women who intend to become pregnant within the period of time of this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br> | Drug: DFRF4539A<br>* multiple ascending doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 3.5 years | 
| Safety: Maximum tolerated dose/dose-limiting toxicities |  | approximately 1.5 years | 
| Recommended Phase II dose for every-3-week or weekly administration of DFRF4539A |  | approximately 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity: Serum antitherapeutic antibody levels |  | approximately 3.5 years | 
| Pharmacokinetics: Area under the concentration - time curve (AUC) |  | 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 |  | approximately 3.5 years | 
| Duration of objective response, defined as time from first documented objective response to progression or death of any cause |  | 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 |  | approximately 3.5 years |