Clinical trial NCT01122875: A Study of the Safety and Pharmacokinetics of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma
Official title: An Open-Label, Multicenter, Phase I Trial of the Safety and Pharmacokinetics of Escalating Doses of MFGR1877S in Patients With Relapsed or Refractory t(4;14)-Positive Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-13
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open-label, dose-escalation study of MFGR1877S in patients with relapsed or refractory t(4;14)-positive multiple myeloma.


Eligibility criteria: Inclusion Criteria:

* ECOG performance status of 0, 1, or 2
* Life expectancy of at least 12 weeks
* Histologic documentation of previously treated t(4;14)-positive multiple myeloma for which no effective standard therapy exists

Exclusion Criteria:

* Prior use of any monoclonal antibody before study treatment
* Treatment with radiotherapy, thalidomide, lenalidomide, bortezomib, any chemotherapeutic agent, or treatment with any other investigational anti-cancer agent within 4 weeks of study treatment
* Completion of autologous stem cell transplant within 6 months prior to study treatment
* Prior allogeneic stem cell transplant
* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy
* Evidence of significant, uncontrolled concomitant diseases, including significant cardiovascular disease or pulmonary disease
* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at screening or any recent major episode of infection requiring treatment with IV antibiotics or hospitalization prior to study treatment
* Recent major surgery (prior to study treatment), other than for diagnosis
* Presence of positive test results for Hepatitis B or Hepatitis C
* Known history of HIV seropositive status
* Women who are pregnant or lactating
* Childbearing potential without agreement to use effective form of contraception for the duration of the study

Primary outcomes:
measure: Incidence and nature of dose-limiting toxicities (DLTs)
timeFrame: Throughout study or until early study discontinuation
Secondary outcomes:
measure: Incidence, nature, and severity of adverse events
timeFrame: Throughout study or until early study discontinuation
measure: Clinical activity of MFGR1877S (objective response, duration of response, and progression-free survival)
timeFrame: Throughout study or until early study discontinuation
measure: Pharmacokinetic parameters of MFGR1877S (total exposure, maximum and minimum serum concentrations, clearance, volume of distribution)
timeFrame: Throughout study or until early study discontinuation
Other outcomes:
Locations:
city: Scottsdale
country: United States
state: Arizona
city: Atlanta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Boston
country: United States
state: Massachusetts
city: Ann Arbor
country: United States
state: Michigan
city: Detroit
country: United States
state: Michigan
city: Hackensack
country: United States
state: New Jersey
city: New York
country: United States
state: New York
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Seattle
country: United States
state: Washington
city: Toronto
country: Canada
state: Ontario
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: