or
forgot password

A Phase II Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma


Phase 2
18 Years
N/A
Not Enrolling
Both
Multiple Myeloma

Thank you

Trial Information

A Phase II Clinical Trial of PXD101 in Patients With Advanced Multiple Myeloma

Inclusion Criteria


Inclusion criteria

- A confirmed diagnosis of multiple myeloma in patients who have failed at least two
prior lines of therapy

- Adequate bone marrow and hepatic functions

- Performance status (PS) less than 2 (Eastern Cooperative Oncology Group [ECOG] scale)

- Estimated life expectancy greater than 3 months

Exclusion criteria

- Anti-cancer therapy within the last 4 weeks

- Co-existing active infection or any co-existing medical condition likely to interfere
with trial procedures

- Significant cardiovascular disease

- A marked baseline prolongation of QT/QTc interval

- Patients with renal insufficiency

- Non-secretory multiple myeloma or symptomatic amyloidosis

- Pregnant or breast-feeding women

- Women of childbearing age and potential who do not use effective contraception

- Known HIV positivity

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

Authority:

United States: Food and Drug Administration

Study ID:

PXD101-301-G

NCT ID:

NCT00131261

Start Date:

January 2005

Completion Date:

June 2007

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

Northwestern University Chicago, Illinois  60611
H. Lee Moffitt Cancer Center Tampa, Florida  33612
James Berenson, MD, Inc West Hollywood, California  90069
Research Facility New York, New York  10021