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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01058434
First received: January 26, 2010
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • frequency and severity of adverse events as per CTCAE [ Time Frame: throughtout the study ] [ Designated as safety issue: No ]
  • Progression free survival (PFS) [ Time Frame: every 4 weeks ] [ Designated as safety issue: No ]
  • Plasma exposure of TKI258 [ Time Frame: during the first 3 cycles ] [ Designated as safety issue: No ]

Enrollment: 43
Study Start Date: May 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TKI258 Drug: TKI258

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058434

  Hide Study Locations
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
France
Novartis Investigative Site
Nantes Cedex 1, France, 44093
Germany
Novartis Investigative Site
Bochum, Germany, 44892
Novartis Investigative Site
Heidelberg, Germany, 69120
Novartis Investigative Site
Köln, Germany, 50924
Netherlands
Novartis Investigative Site
Amsterdam, Netherlands, 1081 HV
Novartis Investigative Site
Rotterdam, Netherlands, 3075 EA
Novartis Investigative Site
Rotterdam, Netherlands, 3015 CE
Turkey
Novartis Investigative Site
Altunizade, Turkey, 34662
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Izmir, Turkey, 35040
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01058434     History of Changes
Other Study ID Numbers: CTKI258A2204, 2009-012417-22
Study First Received: January 26, 2010
Last Updated: July 8, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: National Health and Medical Research Council
Germany: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Turkey: Ministry of Health
Spain: Ministry of Health

Keywords provided by Novartis:
Multiple myeloma
relapsed
refractory
t(4;14)
FGFR3

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

ClinicalTrials.gov processed this record on October 29, 2014