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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

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ClinicalTrials.gov Identifier: NCT01058434
Recruitment Status : Completed
First Posted : January 28, 2010
Last Update Posted : November 16, 2016
Sponsor:
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
Actual Primary Completion Date : February 2013
Actual 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
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


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


  Show 30 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications of Results:
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
relapsed
refractory
t(4;14)
FGFR3

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