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

January 26, 2010
July 8, 2013
May 2010
February 2013   (final data collection date for primary outcome measure)
Overall response rate [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01058434 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation
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

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

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsed or Refractory Multiple Myeloma
Drug: TKI258
Experimental: TKI258
Intervention: Drug: TKI258
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
February 2013
February 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   France,   Germany,   Netherlands,   Turkey
 
NCT01058434
CTKI258A2204, 2009-012417-22
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP