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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01432353
Recruitment Status : Completed
First Posted : September 13, 2011
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: DFRF4539A Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : September 2011
Primary Completion Date : April 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Single Arm Drug: DFRF4539A
multiple ascending doses


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01432353


Locations
United States, Arizona
Scottsdale, Arizona, United States, 85259
United States, California
Duarte, California, United States, 91010
United States, Florida
Jacksonville, Florida, United States, 32224
Sarasota, Florida, United States, 34232
United States, Illinois
Chicago, Illinois, United States, 60611
United States, Maryland
Bethesda, Maryland, United States, 20817
United States, New York
New York, New York, United States, 10021
United States, Tennessee
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Genentech, Inc.
More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT01432353     History of Changes
Other Study ID Numbers: FRF4998g
GO27825 ( Other Identifier: Hoffmann-La Roche )
First Posted: September 13, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases