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 |
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.
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
8
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials