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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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Relapsed or Refractory Multiple Myeloma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CTKI258A2204

NCT ID:

NCT01058434

Start Date:

May 2010

Completion Date:

January 2013

Related Keywords:

  • Relapsed or Refractory Multiple Myeloma
  • Multiple myeloma
  • relapsed
  • refractory
  • t(4;14)
  • FGFR3
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Translocation, Genetic

Name

Location

Lancaster Cancer CenterLancaster, Pennsylvania  17604
Central Coast Medical Oncology CorporationSanta Maria, California  93454
Central Hematology Oncology Medical GroupAlhambra, California  91801
University of Tennessee Cancer Institute SC-2Memphis, Tennessee  38104
University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.Mobile, Alabama  36688
St. Jude Heritage Medical Group Virginia Crosson Cancer CenterFullerton, California  92835
Kootenai Medical Center Kootenai Medical CenterCoeur d'Alene, Idaho  83814
Hematology and Oncology Specialists Dept of Hem&Onc Specialist - 2Metairie, Louisiana  70006
Mayo Clinic - Rochester RochesterRochester, Minnesota  55905
Memorial Sloan Kettering Cancer Center MSKCCNew York, New York  10021
Duke University Medical Center Dept. of DUMC (4)Durham, North Carolina  27710
Cancer Centers of the Carolinas Dept. of CC of the CarolinasGreenville, South Carolina  29605
University of Texas Southwestern Medical Center UTSW Medical CenterDallas, Texas  75390-8527
University of Wisconsin SCMadison, Wisconsin  53792
Medical College of Wisconsin Med College of WisconsinMilwaukee, Wisconsin  53226