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NCT Number: NCT01432353

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DFRF4539A

Drug

multiple ascending doses

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: approximately 3.5 years

  2. Safety: Maximum tolerated dose/dose-limiting toxicities

    Time frame: approximately 1.5 years

  3. Recommended Phase II dose for every-3-week or weekly administration of DFRF4539A

    Time frame: approximately 3.5 years

Secondary outcomes

  1. Immunogenicity: Serum antitherapeutic antibody levels

    Time frame: approximately 3.5 years

  2. Pharmacokinetics: Area under the concentration - time curve (AUC)

    Time frame: approximately 3.5 years

  3. Objective response, tumor assessments according to International Myeloma Working Group (IMWG) Uniform Response Criteria and/or European Bone Marrow Transplant (EBMT) Criteria

    Time frame: approximately 3.5 years

  4. Duration of objective response, defined as time from first documented objective response to progression or death of any cause

    Time frame: approximately 3.5 years

  5. Progression-free survival, defined as time from first study treatment (Cycle 1, Day 1) to disease progression or death during study or within 30 days after last dose of study drug, whichever occurs first

    Time frame: approximately 3.5 years

Sponsors and collaborators

Lead sponsor

Genentech, Inc.

Industry

Registry information

Official study title

An Open-label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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