A Study of DFRF4539A in Patients With Relapsed or Refractory Multiple Myeloma - Full Text View

Purpose

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	Intervention	Phase
Multiple Myeloma	Drug: DFRF4539A	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Multiple Myeloma

U.S. FDA Resources

Further study details as provided by Genentech:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	76
Study Start Date:	September 2011
Estimated Study Completion Date:	March 2015
Estimated Primary Completion Date:	March 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Single Arm	Drug: DFRF4539A multiple ascending doses

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432353

Contacts

Contact: Please reference Study ID Number: FRF4998g www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Locations

United States, Arizona
	Recruiting
Scottsdale, Arizona, United States, 85259
United States, California
	Recruiting
Duarte, California, United States, 91010
United States, Florida
	Recruiting
Jacksonville, Florida, United States, 32224
United States, Illinois
	Recruiting
Chicago, Illinois, United States, 60611
United States, Maryland
	Recruiting
Bethesda, Maryland, United States, 20817
United States, Tennessee
	Recruiting
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Genentech

Investigators

Study Director:

Clinical Trials

Genentech

More Information

No publications provided

Responsible Party:	Genentech
ClinicalTrials.gov Identifier:	NCT01432353 History of Changes
Other Study ID Numbers:	FRF4998g, GO27825
Study First Received:	September 8, 2011
Last Updated:	November 5, 2012
Health Authority:	United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013