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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT01432353
First received: September 8, 2011
Last updated: October 6, 2014
Last verified: October 2014

September 8, 2011
October 6, 2014
September 2011
April 2014   (final data collection date for primary outcome measure)
  • Safety: Incidence of adverse events [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Safety: Maximum tolerated dose/dose-limiting toxicities [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Recommended Phase II dose for every-3-week or weekly administration of DFRF4539A [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Safety: Maximum tolerated dose/dose-limiting toxicities [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01432353 on ClinicalTrials.gov Archive Site
  • Immunogenicity: Serum antitherapeutic antibody levels [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration - time curve (AUC) [ Time Frame: approximately 3.5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Immunogenicity: Serum antitherapeutic antibody levels [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Area under the concentration - time curve (AUC) [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • 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 2.5 years ] [ Designated as safety issue: No ]
  • Duration of objective response, defined as time from first documented objective response to progression or death of any cause [ Time Frame: approximately 2.5 years ] [ Designated as safety issue: No ]
  • 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 2.5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma
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

This multicenter, open-label, dose-escalating study will assess the safety and e fficacy of DFRF4539A in patients with relapsed or refractory multiple myeloma. C ohorts of patients will receive multiple ascending doses of intravenous DFRF4539 A 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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Multiple Myeloma
Drug: DFRF4539A
multiple ascending doses
Experimental: Single Arm
Intervention: Drug: DFRF4539A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01432353
FRF4998g, GO27825
Not Provided
Genentech, Inc.
Genentech, Inc.
Not Provided
Study Director: Clinical Trials Genentech, Inc.
Genentech, Inc.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP