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

Relapsed or Refractory Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01058434
• Other study ID #: CTKI258A2204
• Secondary ID: 2009-012417-22
• Status: Completed
• Phase: Phase 2
• Start date: May 2010
• Est. completion date: February 2013

Study information

• Verified date: August 2020
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Relapsed or Refractory Multiple Myeloma

Intervention

Drug:
• TKI258

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Adelaide	South Australia
Australia	Novartis Investigative Site	Melbourne	Victoria
Australia	Novartis Investigative Site	Prahran	Victoria
Canada	Novartis Investigative Site	Montreal	Quebec
Canada	Novartis Investigative Site	Toronto	Ontario
France	Novartis Investigative Site	Nantes Cedex 1
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Heidelberg
Germany	Novartis Investigative Site	Köln
Netherlands	Novartis Investigative Site	Amsterdam
Netherlands	Novartis Investigative Site	Rotterdam
Netherlands	Novartis Investigative Site	Rotterdam
Turkey	Novartis Investigative Site	Altunizade
Turkey	Novartis Investigative Site	Ankara
Turkey	Novartis Investigative Site	Izmir
United States	Central Hematology Oncology Medical Group	Alhambra	California
United States	Kootenai Medical Center Kootenai Medical Center	Coeur d'Alene	Idaho
United States	University of Texas Southwestern Medical Center UTSW Medical Center	Dallas	Texas
United States	Duke University Medical Center Dept. of DUMC (4)	Durham	North Carolina
United States	Cancer Centers of the Carolinas Dept. of CC of the Carolinas	Greenville	South Carolina
United States	Lancaster Cancer Center	Lancaster	Pennsylvania
United States	University of Wisconsin SC	Madison	Wisconsin
United States	University of Tennessee Cancer Institute SC-2	Memphis	Tennessee
United States	Hematology and Oncology Specialists Dept of Hem&Onc Specialist - 2	Metairie	Louisiana
United States	Medical College of Wisconsin Med College of Wisconsin	Milwaukee	Wisconsin
United States	University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.	Mobile	Alabama
United States	Memorial Sloan Kettering Cancer Center MSKCC	New York	New York
United States	Mayo Clinic - Rochester Rochester	Rochester	Minnesota
United States	Central Coast Medical Oncology Corporation	Santa Maria	California
United States	St. Jude Heritage Medical Group Virginia Crosson Cancer Center	Yorba Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Netherlands,  Turkey, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate		4 weeks
Secondary	frequency and severity of adverse events as per CTCAE		throughout the study
Secondary	Progression free survival (PFS)		every 4 weeks
Secondary	Plasma exposure of TKI258		during the first 3 cycles

External Links

•   CTKI258A2204 Results at Novartis Clinical Trials Results Website