A Study of the Safety and Pharmacokinetics of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

This is a multicenter, open-label, dose-escalation study of MFGR1877S in patients with relapsed or refractory t(4;14)-positive multiple myeloma.

Key facts

Study ID

NCT01122875

Run by

Genentech, Inc.

People needed

14

Starts

2010-11-01

Expected to finish

2012-05-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG performance status of 0, 1, or 2
• 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

You may not qualify if…

• Prior use of any monoclonal antibody before study treatment
• 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

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Detroit, Michigan, United States
• Study site — Hackensack, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Dallas, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Seattle, Washington, United States
• Study site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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