Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation
Primary Purpose
Relapsed or Refractory Multiple Myeloma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TKI258
Sponsored by

About this trial
This is an interventional treatment trial for Relapsed or Refractory Multiple Myeloma focused on measuring Multiple myeloma, relapsed, refractory, t(4;14), FGFR3
Eligibility Criteria
Inclusion Criteria:
- Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment.
- 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)
- 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.
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:
- Patients with non-secretory, or oligosecretory, multiple myeloma.
- Patients with symptomatic amyloidosis, or with plasma cell leukemia.
- 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
Sites / Locations
- University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.
- Central Hematology Oncology Medical Group
- Central Coast Medical Oncology Corporation
- St. Jude Heritage Medical Group Virginia Crosson Cancer Center
- Kootenai Medical Center Kootenai Medical Center
- Hematology and Oncology Specialists Dept of Hem&Onc Specialist - 2
- Mayo Clinic - Rochester Rochester
- Memorial Sloan Kettering Cancer Center MSKCC
- Duke University Medical Center Dept. of DUMC (4)
- Lancaster Cancer Center
- Cancer Centers of the Carolinas Dept. of CC of the Carolinas
- University of Tennessee Cancer Institute SC-2
- University of Texas Southwestern Medical Center UTSW Medical Center
- University of Wisconsin SC
- Medical College of Wisconsin Med College of Wisconsin
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TKI258
Arm Description
Outcomes
Primary Outcome Measures
Overall response rate
Secondary Outcome Measures
frequency and severity of adverse events as per CTCAE
Progression free survival (PFS)
Plasma exposure of TKI258
Full Information
NCT ID
NCT01058434
First Posted
January 26, 2010
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01058434
Brief Title
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
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
Brief Summary
This study will evaluate safety and efficacy of TKI258 in patients with relapsed or refractory multiple myeloma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsed or Refractory Multiple Myeloma
Keywords
Multiple myeloma, relapsed, refractory, t(4;14), FGFR3
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TKI258
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TKI258
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
frequency and severity of adverse events as per CTCAE
Time Frame
throughout the study
Title
Progression free survival (PFS)
Time Frame
every 4 weeks
Title
Plasma exposure of TKI258
Time Frame
during the first 3 cycles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cytopathologically or histologically confirmed diagnosis of multiple myeloma previously requiring systemic treatment.
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)
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.
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:
Patients with non-secretory, or oligosecretory, multiple myeloma.
Patients with symptomatic amyloidosis, or with plasma cell leukemia.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36688
Country
United States
Facility Name
Central Hematology Oncology Medical Group
City
Alhambra
State/Province
California
ZIP/Postal Code
91801
Country
United States
Facility Name
Central Coast Medical Oncology Corporation
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
St. Jude Heritage Medical Group Virginia Crosson Cancer Center
City
Yorba Linda
State/Province
California
ZIP/Postal Code
92886
Country
United States
Facility Name
Kootenai Medical Center Kootenai Medical Center
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Hematology and Oncology Specialists Dept of Hem&Onc Specialist - 2
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Mayo Clinic - Rochester Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center MSKCC
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Duke University Medical Center Dept. of DUMC (4)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Lancaster Cancer Center
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Cancer Centers of the Carolinas Dept. of CC of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
University of Tennessee Cancer Institute SC-2
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
University of Texas Southwestern Medical Center UTSW Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8527
Country
United States
Facility Name
University of Wisconsin SC
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin Med College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Novartis Investigative Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Novartis Investigative Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Novartis Investigative Site
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 1A1
Country
Canada
Facility Name
Novartis Investigative Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Facility Name
Novartis Investigative Site
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Novartis Investigative Site
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Novartis Investigative Site
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3015 CE
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Altunizade
ZIP/Postal Code
34662
Country
Turkey
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novartis Investigative Site
City
Izmir
ZIP/Postal Code
35040
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
25402977
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.
Results Reference
result
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9317
Description
CTKI258A2204 Results at Novartis Clinical Trials Results Website
Learn more about this trial
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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