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Phase II Study of PTK787/ZK222584 in Multiple Myeloma

Phase 2
18 Years
Not Enrolling
Multiple Myeloma

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Trial Information

Phase II Study of PTK787/ZK222584 in Multiple Myeloma

Patients will take PTK orally once a day for the duration of their time on the study. Each
cycle of chemotherapy will last for 4 weeks.

Measurement of vital signs will be done weekly during the first month of treatment.

Physical exam, vital signs, blood work, a quality of life assessment, and x-ray or MRI wil
be performed every 4 weeks.

Patients will remain on the study until their disease fails to respond to treatment or there
are intolerable side effects. Typically treatment is performed for 12 weeks and up to one
year in patients that are stable and responding.

Inclusion Criteria:

- Older than 18 years of age.

- Confirmed diagnosis of active progressive multiple myeloma

- History of > 2 prior cytotoxic treatment regimens. Bone marrow transplantation will
be considered as one regimen.

- Current measurable disease based on serum and/or urine M protein and/or measurable

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

- Absolute neutrophil count (ANC) > 1,500 mm3

- Platelets > 100,000 mm3

- Serum creatinine < 1.5 upper limit of normal (ULN)

- Serum bilirubin < 1.5 ULN


- Life expectancy > 12 weeks

Exclusion Criteria:

- Chemotherapy < 3 weeks prior to registration.

- Biologic or immunotherapy < 2 weeks prior to registration

- Full field radiotherapy < 4 weeks or limited field radiotherapy < 2 weeks prior to

- History or presence of central nervous system (CNS) disease

- History of leukemia

- History of another primary malignancy with the exception of inactive basal or
squamous cell carcinoma of the skin

- Major surgery < 4 weeks prior to registration

- Prior therapy with anti-vascular endothelial growth factor (VEGF) agents excluding
thalidomide, Revimid, velcade and arsenic trioxide

- Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung

- Pleural effusion or ascites that cause respiratory compromise

- Female patients that are pregnant or breast feeding

- Uncontrolled high blood pressure, history of labile hypertension or history of poor
compliance with an antihypertensive regimen

- Unstable angina pectoris

- Symptomatic congestive heart failure

- Myocardial infarction < 6 months prior to registration

- Serious uncontrolled cardiac arrhythmia

- Uncontrolled diabetes

- Active or uncontrolled infection

- Acute or chronic liver disease

- Impairment of gastrointestinal (GI) function or GI disease

- Confirmed HIV infection

Type of Study:


Study Design:

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

Outcome Measure:

To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma

Principal Investigator

Nikhil Munshi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

December 2003

Completion Date:

October 2006

Related Keywords:

  • Multiple Myeloma
  • Multiple myeloma
  • PTK
  • Relapsed multiple myeloma
  • Refractory Multiple myeloma
  • Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Dana-Farber Cancer Institute Boston, Massachusetts  02115