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Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation

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.
ClinicalTrials.gov Identifier: NCT01058434
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : November 16, 2016
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will evaluate safety and efficacy of TKI258 in patients with relapsed or refractory multiple myeloma

Condition or disease Intervention/treatment Phase
Relapsed or Refractory Multiple Myeloma Drug: TKI258 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Multi-center, Non-randomized, Open-label Study of TKI258 in Patients With Relapsed or Refractory Multiple Myeloma, Who Are With or Without t(4;14) Translocation
Study Start Date : May 2010
Primary Completion Date : February 2013
Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: TKI258 Drug: TKI258

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. frequency and severity of adverse events as per CTCAE [ Time Frame: throughtout the study ]
  2. Progression free survival (PFS) [ Time Frame: every 4 weeks ]
  3. Plasma exposure of TKI258 [ Time Frame: during the first 3 cycles ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment.
  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:

  1. Patients with non-secretory, or oligosecretory, multiple myeloma.
  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.

Other protocol-defined inclusion/exclusion criteria may apply

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 ClinicalTrials.gov identifier (NCT number): NCT01058434

  Hide Study Locations
United States, Alabama
University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.
Mobile, Alabama, United States, 36688
United States, California
Central Hematology Oncology Medical Group
Alhambra, California, United States, 91801
Central Coast Medical Oncology Corporation
Santa Maria, California, United States, 93454
St. Jude Heritage Medical Group Virginia Crosson Cancer Center
Yorba Linda, California, United States, 92886
United States, Idaho
Kootenai Medical Center Kootenai Medical Center
Coeur d'Alene, Idaho, United States, 83814
United States, Louisiana
Hematology and Oncology Specialists Dept of Hem&Onc Specialist - 2
Metairie, Louisiana, United States, 70006
United States, Minnesota
Mayo Clinic - Rochester Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Memorial Sloan Kettering Cancer Center MSKCC
New York, New York, United States, 10021
United States, North Carolina
Duke University Medical Center Dept. of DUMC (4)
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Lancaster Cancer Center
Lancaster, Pennsylvania, United States, 17601
United States, South Carolina
Cancer Centers of the Carolinas Dept. of CC of the Carolinas
Greenville, South Carolina, United States, 29605
United States, Tennessee
University of Tennessee Cancer Institute SC-2
Memphis, Tennessee, United States, 38104
United States, Texas
University of Texas Southwestern Medical Center UTSW Medical Center
Dallas, Texas, United States, 75390-8527
United States, Wisconsin
University of Wisconsin SC
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin Med College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Australia, South Australia
Novartis Investigative Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Novartis Investigative Site
Melbourne, Victoria, Australia, 3002
Novartis Investigative Site
Prahran, Victoria, Australia, 3181
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Novartis Investigative Site
Montreal, Quebec, Canada, H3A 1A1
Novartis Investigative Site
Nantes Cedex 1, France, 44093
Novartis Investigative Site
Bochum, Germany, 44892
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Köln, Germany, 50924
Novartis Investigative Site
Amsterdam, Netherlands, 1081 HV
Novartis Investigative Site
Rotterdam, Netherlands, 3015 CE
Novartis Investigative Site
Rotterdam, Netherlands, 3075 EA
Novartis Investigative Site
Altunizade, Turkey, 34662
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Izmir, Turkey, 35040
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01058434     History of Changes
Other Study ID Numbers: CTKI258A2204
2009-012417-22 ( EudraCT Number )
First Posted: January 28, 2010    Key Record Dates
Last Update Posted: November 16, 2016
Last Verified: July 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases