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

NCT01432353 | Completed Phase 1

• 2 other identifiers: FRF4998gGO27825
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 8

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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• Safety: Incidence of adverse events

  approximately 3.5 years

• Safety: Maximum tolerated dose/dose-limiting toxicities

  approximately 1.5 years

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

  approximately 3.5 years

Secondary Outcomes (5)

• Immunogenicity: Serum antitherapeutic antibody levels

  approximately 3.5 years

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

  approximately 3.5 years

• 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

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

  approximately 3.5 years

• 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

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: DFRF4539A

Interventions

DFRF4539A DRUG

multiple ascending doses

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (8)

Unknown Facility

Scottsdale, Arizona, 85259, United States

Location

Unknown Facility

Duarte, California, 91010, United States

Location

Unknown Facility

Jacksonville, Florida, 32224, United States

Location

Unknown Facility

Sarasota, Florida, 34232, United States

Location

Unknown Facility

Chicago, Illinois, 60611, United States

Location

Unknown Facility

Bethesda, Maryland, 20817, United States

Location

Unknown Facility

New York, New York, 10021, United States

Location

Unknown Facility

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Trials

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2011
• First Posted: September 13, 2011
• Study Start: September 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (8)