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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence and nature of dose-limiting toxicities (DLTs)

Outcome Time Frame:

Throughout study or until early study discontinuation

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

MFG4809g

NCT ID:

NCT01122875

Start Date:

November 2010

Completion Date:

October 2012

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Phoenix, Arizona  85012
Albany, New York  12208
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Hackensack, New Jersey  07601
Boston, Massachusetts  
Salt Lake City, Utah  84112