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

Completed · Phase 2

Conditions studied: Relapsed or Refractory Multiple Myeloma

In brief

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

Key facts

Study ID

NCT01058434

Run by

Novartis Pharmaceuticals

People needed

43

Starts

2010-05-01

Expected to finish

2013-02-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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