A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma

Completed · Phase 1

Conditions studied: Multiple Myeloma

In brief

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.

Key facts

Study ID

NCT01432353

Run by

Genentech, Inc.

People needed

39

Starts

2011-09-01

Expected to finish

2014-04-01

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…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — Scottsdale, Arizona, United States
• Study site — Duarte, California, United States
• Study site — Jacksonville, Florida, United States
• Study site — Sarasota, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Bethesda, Maryland, United States
• Study site — New York, New York, United States
• Study site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.