Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01058434

Collaborator

(none)

Enrollment

Locations

Arm

33.1

Duration (Months)

1.4

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Relapsed or Refractory Multiple Myeloma	Drug: TKI258	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TKI258	Drug: TKI258

Arm

Intervention/Treatment

Experimental: TKI258

Drug: TKI258

Outcome Measures

Primary Outcome Measures

Overall response rate [4 weeks]

Secondary Outcome Measures

frequency and severity of adverse events as per CTCAE [throughout the study]
Progression free survival (PFS) [every 4 weeks]
Plasma exposure of TKI258 [during the first 3 cycles]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.	Mobile	Alabama	United States	36688
2	Central Hematology Oncology Medical Group	Alhambra	California	United States	91801
3	Central Coast Medical Oncology Corporation	Santa Maria	California	United States	93454
4	St. Jude Heritage Medical Group Virginia Crosson Cancer Center	Yorba Linda	California	United States	92886
5	Kootenai Medical Center Kootenai Medical Center	Coeur d'Alene	Idaho	United States	83814
6	Hematology and Oncology Specialists Dept of Hem&Onc Specialist - 2	Metairie	Louisiana	United States	70006
7	Mayo Clinic - Rochester Rochester	Rochester	Minnesota	United States	55905
8	Memorial Sloan Kettering Cancer Center MSKCC	New York	New York	United States	10021
9	Duke University Medical Center Dept. of DUMC (4)	Durham	North Carolina	United States	27710
10	Lancaster Cancer Center	Lancaster	Pennsylvania	United States	17601
11	Cancer Centers of the Carolinas Dept. of CC of the Carolinas	Greenville	South Carolina	United States	29605
12	University of Tennessee Cancer Institute SC-2	Memphis	Tennessee	United States	38104
13	University of Texas Southwestern Medical Center UTSW Medical Center	Dallas	Texas	United States	75390-8527
14	University of Wisconsin SC	Madison	Wisconsin	United States	53792
15	Medical College of Wisconsin Med College of Wisconsin	Milwaukee	Wisconsin	United States	53226
16	Novartis Investigative Site	Adelaide	South Australia	Australia	5000
17	Novartis Investigative Site	Melbourne	Victoria	Australia	3002
18	Novartis Investigative Site	Prahran	Victoria	Australia	3181
19	Novartis Investigative Site	Toronto	Ontario	Canada	M5G 2M9
20	Novartis Investigative Site	Montreal	Quebec	Canada	H3A 1A1
21	Novartis Investigative Site	Nantes Cedex 1		France	44093
22	Novartis Investigative Site	Bochum		Germany	44892
23	Novartis Investigative Site	Heidelberg		Germany	69120
24	Novartis Investigative Site	Köln		Germany	50924
25	Novartis Investigative Site	Amsterdam		Netherlands	1081 HV
26	Novartis Investigative Site	Rotterdam		Netherlands	3015 CE
27	Novartis Investigative Site	Rotterdam		Netherlands	3075 EA
28	Novartis Investigative Site	Altunizade		Turkey	34662
29	Novartis Investigative Site	Ankara		Turkey	06100
30	Novartis Investigative Site	Izmir		Turkey	35040