Clinical trial NCT01432353: A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: approximately 3.5 years
measure: Safety: Maximum tolerated dose/dose-limiting toxicities
timeFrame: approximately 1.5 years
measure: Recommended Phase II dose for every-3-week or weekly administration of DFRF4539A
timeFrame: approximately 3.5 years
Secondary outcomes:
measure: Immunogenicity: Serum antitherapeutic antibody levels
timeFrame: approximately 3.5 years
measure: Pharmacokinetics: Area under the concentration - time curve (AUC)
timeFrame: approximately 3.5 years
measure: Objective response, tumor assessments according to International Myeloma Working Group (IMWG) Uniform Response Criteria and/or European Bone Marrow Transplant (EBMT) Criteria
timeFrame: approximately 3.5 years
measure: Duration of objective response, defined as time from first documented objective response to progression or death of any cause
timeFrame: approximately 3.5 years
measure: 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
timeFrame: approximately 3.5 years
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Duarte
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Bethesda
country: United States
state: Maryland
city: New York
country: United States
state: New York
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: