PTK/ZK as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00240162|
Recruitment Status : Terminated (investigator letter from drug manufacturer stating animal studies showed increased risk of cancer which was an unknown adverse event)
First Posted : October 17, 2005
Results First Posted : September 4, 2014
Last Update Posted : September 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Drug: PTK787/ZK 222584||Phase 2|
To evaluate the efficacy of PTK787/ZK 222584, in inducing at least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are < 5 g/dL following high dose chemotherapy (HDCT) and Autologous Stem Cell Transplantation (ASCT).
To assess the time to progression and disease free survival of patients treated with PTK787/ZK 222584.
To assess the safety and tolerability of PTK787/ZK 222584 in multiple myeloma patients following ASCT.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of PTK787/ZK 222584, a Novel, Oral Angiogenesis Inhibitor as Post Transplant Maintenance Therapy in Patients With Multiple Myeloma Following High Dose Chemotherapy and Autologous Stem Cell Transplant|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Experimental: 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.
Drug: PTK787/ZK 222584
Other Name: N/Bemzoylstaurosporine
- 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 ]
- Time to Progression [ Time Frame: Until the patient progresses or expires (up to 457 days) ]
Time to progression is from the start of treatment until the first date that criteria for progressive disease (PD) are met.
- 25% increase in the level of the serum monoclonal paraprotein, which must also be an absolute increase of at least 0.5 g/dL and confirmed by at lease 1 repeated investigation.
- 25% increase in the 24 hr urinary light chain excretion, which must also be an absolute increase of at least 200 mg/ 24 hr and confirmed by at least 1 repeated investigation.
35% increase in plasma cells in a bone marrow aspirate or on trephine biopsy, which must also be an absolute increase of at least 10%.
- Increase in the size of existing bone lesions or soft tissue plasmacytomas
- New lytic bone lesions or soft tissue plasmacytomas or definite increase in the size of residual bone lesions (development of a compression fracture does not exclude continued response and may not indicate progression).
- Hypercalcemia - corrected serum calcium > 11.5 mg/dL
- Safety and Tolerability of PTK787/ZK 222584 [ Time Frame: 30 days after treatment ends [median of 15 cycles (11-32)] ]Number of Grade 3/4 adverse events per the National Cancer Institute (NCI) Common Toxicity Criteria v 3.0.
- Disease Free Survival [ Time Frame: Until the patient expires ]
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 ClinicalTrials.gov identifier (NCT number): NCT00240162
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Ravi Vij, M.D.||Washington University School of Medicine|