Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation
NCT ID: NCT01058434
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2010-05-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TKI258
TKI258
Interventions
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TKI258
Eligibility Criteria
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Inclusion Criteria
2. Evidence of relapsed or refractory disease as documented from the prior treatment history. (Refractory myeloma is defined as disease that is non-responsive while on salvage therapy, or progresses within 60 days of last therapy. Relapsed myeloma is defined as previously treated myeloma which after a period of being off-therapy requires the initiation of salvage therapy. Detailed definitions provided in the PTS-1)
3. Have received at least 2 prior treatment regimens for multiple myeloma including chemotherapy, autologous transplantation, immunotherapy, or other investigational agents. Pre-planned induction, followed by transplant and maintenance should be considered as one regimen.
4. Presence of measurable disease as defined by at least one of the following;
* Serum M-protein ≥ 1g/dL (measurable disease)
* Urine M-protein ≥ 200mg/24 hours by protein electrophoresis (measurable disease)
Exclusion Criteria
2. Patients with symptomatic amyloidosis, or with plasma cell leukemia.
3. Patients who have received allogeneic stem cell transplantation and who show evidence of active graft-versus-host disease that requires immunosuppressive therapy.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.
Mobile, Alabama, United States
Central Hematology Oncology Medical Group
Alhambra, California, United States
Central Coast Medical Oncology Corporation
Santa Maria, California, United States
St. Jude Heritage Medical Group Virginia Crosson Cancer Center
Yorba Linda, California, United States
Kootenai Medical Center Kootenai Medical Center
Coeur d'Alene, Idaho, United States
Hematology and Oncology Specialists Dept of Hem&Onc Specialist - 2
Metairie, Louisiana, United States
Mayo Clinic - Rochester Rochester
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center MSKCC
New York, New York, United States
Duke University Medical Center Dept. of DUMC (4)
Durham, North Carolina, United States
Lancaster Cancer Center
Lancaster, Pennsylvania, United States
Cancer Centers of the Carolinas Dept. of CC of the Carolinas
Greenville, South Carolina, United States
University of Tennessee Cancer Institute SC-2
Memphis, Tennessee, United States
University of Texas Southwestern Medical Center UTSW Medical Center
Dallas, Texas, United States
University of Wisconsin SC
Madison, Wisconsin, United States
Medical College of Wisconsin Med College of Wisconsin
Milwaukee, Wisconsin, United States
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
Melbourne, Victoria, Australia
Novartis Investigative Site
Prahran, Victoria, Australia
Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Nantes, , France
Novartis Investigative Site
Bochum, , Germany
Novartis Investigative Site
Cologne, , Germany
Novartis Investigative Site
Heidelberg, , Germany
Novartis Investigative Site
Amsterdam, , Netherlands
Novartis Investigative Site
Rotterdam, , Netherlands
Novartis Investigative Site
Rotterdam, , Netherlands
Novartis Investigative Site
Altunizade, , Turkey (Türkiye)
Novartis Investigative Site
Ankara, , Turkey (Türkiye)
Novartis Investigative Site
Izmir, , Turkey (Türkiye)
Countries
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References
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Scheid C, Reece D, Beksac M, Spencer A, Callander N, Sonneveld P, Kalimi G, Cai C, Shi M, Scott JW, Stewart AK. Phase 2 study of dovitinib in patients with relapsed or refractory multiple myeloma with or without t(4;14) translocation. Eur J Haematol. 2015 Oct;95(4):316-24. doi: 10.1111/ejh.12491. Epub 2015 Jan 22.
Related Links
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CTKI258A2204 Results at Novartis Clinical Trials Results Website
Other Identifiers
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2009-012417-22
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTKI258A2204
Identifier Type: -
Identifier Source: org_study_id