A Study of the Safety and Pharmacokinetics of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma
NCT ID: NCT01122875
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
14 participants
INTERVENTIONAL
2010-11-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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A
MFGR1877S
Intravenous repeating dose
Interventions
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MFGR1877S
Intravenous repeating dose
Eligibility Criteria
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Inclusion Criteria
* Life expectancy of at least 12 weeks
* Histologic documentation of previously treated t(4;14)-positive multiple myeloma for which no effective standard therapy exists
Exclusion Criteria
* Treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 4 weeks of study treatment
* Completion of autologous stem cell transplant within 6 months prior to study treatment
* Prior allogeneic stem cell transplant
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* Evidence of significant, uncontrolled concomitant diseases, including significant cardiovascular disease or pulmonary disease
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at screening or any recent major episode of infection requiring treatment with IV antibiotics or hospitalization prior to study treatment
* Recent major surgery (prior to study treatment), other than for diagnosis
* Presence of positive test results for Hepatitis B or Hepatitis C
* Known history of HIV seropositive status
* Women who are pregnant or lactating
* Childbearing potential without agreement to use effective form of contraception for the duration of the 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
Atlanta, Georgia, United States
Chicago, Illinois, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Hackensack, New Jersey, United States
New York, New York, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Toronto, Ontario, Canada
Countries
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Other Identifiers
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GO01331
Identifier Type: OTHER
Identifier Source: secondary_id
MFG4809g
Identifier Type: -
Identifier Source: org_study_id