Clinical trial NCT01058434: Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsed or Refractory Multiple Myeloma
Keywords: Multiple myeloma
relapsed
refractory
t(4;14)
FGFR3
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-01-28
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Overall response rate
timeFrame: 4 weeks
Secondary outcomes:
measure: frequency and severity of adverse events as per CTCAE
timeFrame: throughout the study
measure: Progression free survival (PFS)
timeFrame: every 4 weeks
measure: Plasma exposure of TKI258
timeFrame: during the first 3 cycles
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.
state: Alabama
city: Alhambra
country: United States
facility: Central Hematology Oncology Medical Group
state: California
city: Santa Maria
country: United States
facility: Central Coast Medical Oncology Corporation
state: California
city: Yorba Linda
country: United States
facility: St. Jude Heritage Medical Group Virginia Crosson Cancer Center
state: California
city: Coeur d'Alene
country: United States
facility: Kootenai Medical Center Kootenai Medical Center
state: Idaho
city: Metairie
country: United States
facility: Hematology and Oncology Specialists Dept of Hem&Onc Specialist - 2
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic - Rochester Rochester
state: Minnesota
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center MSKCC
state: New York
city: Durham
country: United States
facility: Duke University Medical Center Dept. of DUMC (4)
state: North Carolina
city: Lancaster
country: United States
facility: Lancaster Cancer Center
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas Dept. of CC of the Carolinas
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee Cancer Institute SC-2
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center UTSW Medical Center
state: Texas
city: Madison
country: United States
facility: University of Wisconsin SC
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Med College of Wisconsin
state: Wisconsin
city: Adelaide
country: Australia
facility: Novartis Investigative Site
state: South Australia
city: Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Prahran
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Nantes Cedex 1
country: France
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Heidelberg
country: Germany
facility: Novartis Investigative Site
city: Köln
country: Germany
facility: Novartis Investigative Site
city: Amsterdam
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
city: Altunizade
country: Turkey
facility: Novartis Investigative Site
city: Ankara
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Scheid C, Reece D, Beksac M, Spencer A, Callander N, Sonneveld P, Kalimi G, Cai C, Shi M, Scott JW, Stewart AK. Phase 2 study of dovitinib in patients with relapsed or refractory multiple myeloma with or without t(4;14) translocation. Eur J Haematol. 2015 Oct;95(4):316-24. doi: 10.1111/ejh.12491. Epub 2015 Jan 22.