Status:
COMPLETED
A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma
Lead Sponsor:
Genentech, Inc.
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT01432353
Start Date
September 1 2011
End Date
April 1 2014
Last Update
November 2 2016
Active Locations (8)
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1
Scottsdale, Arizona, United States, 85259
2
Duarte, California, United States, 91010
3
Jacksonville, Florida, United States, 32224
4
Sarasota, Florida, United States, 34232