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

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01432353
• Other study ID #: FRF4998g
• Secondary ID: GO27825
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2011
• Last updated: November 1, 2016
• Start date: September 2011
• Est. completion date: April 2014

Study information

• Verified date: November 2016
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• DFRF4539A
multiple ascending doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 3.5 years	No
Primary	Safety: Maximum tolerated dose/dose-limiting toxicities		approximately 1.5 years	No
Primary	Recommended Phase II dose for every-3-week or weekly administration of DFRF4539A		approximately 3.5 years	No
Secondary	Immunogenicity: Serum antitherapeutic antibody levels		approximately 3.5 years	No
Secondary	Pharmacokinetics: Area under the concentration - time curve (AUC)		approximately 3.5 years	No
Secondary	Objective response, tumor assessments according to International Myeloma Working Group (IMWG) Uniform Response Criteria and/or European Bone Marrow Transplant (EBMT) Criteria		approximately 3.5 years	No
Secondary	Duration of objective response, defined as time from first documented objective response to progression or death of any cause		approximately 3.5 years	No
Secondary	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		approximately 3.5 years	No