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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genentech, Inc.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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