A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma
NCT ID: NCT01432353
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2011-09-30
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
DFRF4539A
multiple ascending doses
Interventions
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DFRF4539A
multiple ascending doses
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Scottsdale, Arizona, United States
Duarte, California, United States
Jacksonville, Florida, United States
Sarasota, Florida, United States
Chicago, Illinois, United States
Bethesda, Maryland, United States
New York, New York, United States
Nashville, Tennessee, United States
Countries
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Other Identifiers
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GO27825
Identifier Type: OTHER
Identifier Source: secondary_id
FRF4998g
Identifier Type: -
Identifier Source: org_study_id