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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 UniversityChicago, Illinois  60611
H. Lee Moffitt Cancer CenterTampa, Florida  33612
James Berenson, MD, IncWest Hollywood, California  90069
Research FacilityNew York, New York  10021