PTK/ZK as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma

This study has been terminated.
(investigator letter from drug manufacturer stating animal studies showed increased risk of cancer which was an unknown adverse event)
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00240162
First received: October 13, 2005
Last updated: September 5, 2014
Last verified: September 2014
Results First Received: August 22, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Multiple Myeloma
Intervention: Drug: PTK787/ZK 222584

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study opened to participant enrollment on 09/21/2005 and closed to participant enrollment on 06/17/2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
PTK787/ZK 222584 Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.

Participant Flow:   Overall Study
    PTK787/ZK 222584  
STARTED     21  
COMPLETED     21  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PTK787/ZK 222584 Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.

Baseline Measures
    PTK787/ZK 222584  
Number of Participants  
[units: participants]
  21  
Age  
[units: years]
Median ( Full Range )
  57  
  ( 38 to 76 )  
Gender  
[units: participants]
 
Female     7  
Male     14  
Region of Enrollment  
[units: participants]
 
United States     21  
Durie-Salmon stage at study entry [1]
[units: participants]
 
Stage IA     7  
Stage IIA     7  
Stage IIIA     7  
International Staging System (ISS) at study entry [2]
[units: participants]
 
Stage I     17  
Stage II     3  
Stage III     1  
Beta-2 Microglobulin at study entry  
[units: mg/L]
Median ( Full Range )
  2.3  
  ( 1.2 to 5.65 )  
Paraprotein at study entry  
[units: participants]
 
IgG     18  
IgA     3  
Serum M-spike at study entry  
[units: g/dL]
Median ( Full Range )
  0.5  
  ( 0 to 2.4 )  
Bone marrow aspirate plasma  
[units: percentage of cells at study entry]
Median ( Full Range )
  5  
  ( 0 to 15 )  
Conventional cytogenetics  
[units: participants]
 
Normal karyotype     8  
Monosomy 13     1  
Hypodiploid karyotype with t(11;14)     1  
Monosomy 13 and t(4:14)     2  
Others     8  
No available cytogenetics     1  
[1]
  • Stage I:Hemoglobin (hgb) level >10.5 g/dL & calcium level is normal or ≤12 mg/dL & Low M-protein levels (IgG level is <5 g/dL; IgA level <3 g/dL) & Urine light chains <4 g per 24 hours, & Bone X-ray normal bone structure or a solitary bone plasmacytoma
  • Stage IIA:Levels of hgb, calcium, M-protein and Bence Jones protein fall somewhere between stages I and III & No kidney failure (creatinine ≤2 mg/dL)
  • Stage III: High M protein (IgG is>7 g/dL; IgA is >5g/dL) & Urine light chains >12 g per 24 hours & hgb <8.5 g/dL & calcium >2 m/dL) & X-ray studies of bone >3 lytic bone lesions
[2]
  • Stage I:Beta 2-microglobulin level <3.5 mg/L & Albumin level ≥3.5 g/dL
  • Stage II Beta 2-microglobulin level <3.5 g/L & Albumin level <3.5 g/dL OR Beta 2-microglobulin level is 3.5 to 5.5 mg/L
  • Stage III Beta 2-microglobulin level is ≥5.5 mg/L



  Outcome Measures
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1.  Primary:   Detectable Paraprotein Level (IgG or IgA)at ≤5 g/dL Who Show a 50% Reduction (Complete Response + Partial Response) in Their Paraprotein After Starting Treatment With the Study Drug   [ Time Frame: Day 90 ]

2.  Secondary:   Time to Progression   [ Time Frame: Until the patient progresses or expires (up to 457 days) ]

3.  Secondary:   Safety and Tolerability of PTK787/ZK 222584   [ Time Frame: 30 days after treatment ends [median of 15 cycles (11-32)] ]

4.  Secondary:   Disease Free Survival   [ Time Frame: Until the patient expires ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
In November 2008, it was reported that the drug might have carcinogenic potential in animal models. At that time, the remaining three patients were taken off study.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Ravi Vij, M.D.
Organization: Washington University School of Medicine
phone: 314-454-8304
e-mail: rvij@dom.wustl.edu


No publications provided


Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00240162     History of Changes
Other Study ID Numbers: 05-0639, IND#: 72,721
Study First Received: October 13, 2005
Results First Received: August 22, 2014
Last Updated: September 5, 2014
Health Authority: United States: Food and Drug Administration