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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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Multiple Myeloma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Safety: Incidence of adverse events

Outcome Time Frame:

approximately 3.5 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

FRF4998g

NCT ID:

NCT01432353

Start Date:

September 2011

Completion Date:

January 2016

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Hinsdale, Illinois  60521
Phoenix, Arizona  85012
Fountain Valley, California  92708
Miami, Florida  33176
Albany, New York  12208
Nashville, Tennessee  37203-1632
Baltimore, Maryland  21287