Safety and Efficacy of TKI258 in Relapsed or Refractory Multiple Myeloma Patients, Who Are With or Without t(4;14) Chromosomal Translocation
- Registration Number
- NCT01058434
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
This study will evaluate safety and efficacy of TKI258 in patients with relapsed or refractory multiple myeloma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
-
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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TKI258 TKI258 -
- Primary Outcome Measures
Name Time Method Overall response rate 4 weeks
- Secondary Outcome Measures
Name Time Method frequency and severity of adverse events as per CTCAE throughout the study Plasma exposure of TKI258 during the first 3 cycles Progression free survival (PFS) every 4 weeks
Trial Locations
- Locations (16)
University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst.
🇺🇸Mobile, Alabama, United States
Duke University Medical Center Dept. of DUMC (4)
🇺🇸Durham, North Carolina, United States
St. Jude Heritage Medical Group Virginia Crosson Cancer Center
🇺🇸Yorba Linda, California, United States
Central Hematology Oncology Medical Group
🇺🇸Alhambra, California, United States
Mayo Clinic - Rochester Rochester
🇺🇸Rochester, Minnesota, United States
Central Coast Medical Oncology Corporation
🇺🇸Santa Maria, California, United States
Lancaster Cancer Center
🇺🇸Lancaster, Pennsylvania, United States
Novartis Investigative Site
🇹🇷Izmir, Turkey
Memorial Sloan Kettering Cancer Center MSKCC
🇺🇸New York, New York, United States
Hematology and Oncology Specialists Dept of Hem&Onc Specialist - 2
🇺🇸Metairie, Louisiana, United States
University of Texas Southwestern Medical Center UTSW Medical Center
🇺🇸Dallas, Texas, United States
Medical College of Wisconsin Med College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Tennessee Cancer Institute SC-2
🇺🇸Memphis, Tennessee, United States
University of Wisconsin SC
🇺🇸Madison, Wisconsin, United States
Kootenai Medical Center Kootenai Medical Center
🇺🇸Coeur d'Alene, Idaho, United States
Cancer Centers of the Carolinas Dept. of CC of the Carolinas
🇺🇸Greenville, South Carolina, United States