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

  Show 30 Study Locations
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
Translocation, Genetic
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
Chromosome Aberrations
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014