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



Status:Completed
Conditions:Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:September 2011
End Date:April 2014

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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

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.


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
We found this trial at
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