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Protein Tyrosine Kinases (PTK) in Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00165347
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : December 21, 2007
Brigham and Women's Hospital
Information provided by:
Dana-Farber Cancer Institute

Brief Summary:
The purpose of this study is to determine whether or not cancer cells in the body are affected by PTK and whether it affects the growth of these cells.

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: PTK787/ZK222584 Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of PTK787/ZK222584 in Multiple Myeloma
Study Start Date : December 2003
Actual Primary Completion Date : October 2006
Actual Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Primary Outcome Measures :
  1. To determine the effectiveness of PTK in treating patients with relapsed or refractory myeloma

Secondary Outcome Measures :
  1. To evaluate the progression free survival of patients treated with PTK
  2. to investigate the safety of PTK in patients with relapsed/refractory multiple myeloma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 plasmacytoma.
  • 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
  • AST/AGOT and ALT/SGPT < 3.0 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 registration.
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00165347

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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
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Principal Investigator: Nikhil Munshi, MD Dana-Farber Cancer Institute

Layout table for additonal information Identifier: NCT00165347     History of Changes
Other Study ID Numbers: 03-257
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007
Keywords provided by Dana-Farber Cancer Institute:
Multiple myeloma
Relapsed multiple myeloma
Refractory Multiple myeloma
Additional relevant MeSH terms:
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Blood Protein Disorders
Protein Kinase Inhibitors
Enzyme Inhibitors
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Molecular Mechanisms of Pharmacological Action